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The effectiveness of penile curvature treatment by cavernous body rotation and plication of the tunica albuginea

The effectiveness of penile curvature treatment by cavernous body rotation and plication of the... Background There are several approaches to the surgical treatment of the penile curvature conditionally divided into three large groups: tunica albuginea plication ( TAP), corpus cavernosum rotation (CR), and transplantation of various materials. The study aims to compare the effectiveness of TAP and CR techniques in the treatment of penile curvature. There was a prospective randomized study of the effectiveness of surgical treatment of patients with an established diagnosis of the penile curvature from 2017 to 2020 in Irkutsk, Russian Federation. The final analysis of the results included 22 cases. Results The analysis of the comparative intergroup effectiveness of the treatment performed based on the criteria established in the study showed good treatment results in 8 (88.8%) patients in the CR group and 9 (69.2%) patients in the TAP group (p = 0.577). The other patients obtained satisfactory results. There were no negative outcomes. Simple logistic regression analysis showed that the preoperative flexion angle > 60 degrees (OR 2.7; 95% CI 0.12; 5.28; p = 0.040) was significant in predicting the complaints of penile shortening during TAP. Both methods are safe, effec- tive, and bring minimal risk of complications. Conclusion Thus, the effectiveness of both treatment methods is comparable. However, TAP surgery is not recom- mended for patients with an initial curvature of more than 60 degrees. Keywords Penile curvature, Congenital curvature of the penis, Corporoplasty, Rotational corporoplasty, Plication of the tunica albuginea of the corpora cavernosa, Corporal rotation Résumé Contexte Il existe plusieurs approches du traitement chirurgical de la courbure pénienne, divisées en trois grands groupes : plicature de la tunique albuginée (PTA), rotation du corps caverneux (RCC) et transplantation de divers matériaux. La présente étude vise à comparer l’efficacité des techniques PTA et RCC dans le traitement de la courbure du pénis. Il s’agit d’une étude prospective randomisée de l’efficacité du traitement chirurgical de patients ayant un diagnostic établi de courbure du pénis, de 2017 à 2020 à Irkoutsk, en Fédération de Russie. L’analyse finale des résul- tats comprend 22 cas. *Correspondence: Vladimir Vorobev vlvorobev7@rambler.ru Full list of author information is available at the end of the article © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 2 of 11 Résultats L’analyse de l’efficacité comparative intergroupe du traitement effectué sur la base des critères établis dans l’étude, a montré de bons résultats du traitement chez 8 (88,8%) patients du groupe RCC et 9 (69,2%) patients du groupe PTA (p = 0,577). Les autres patients ont obtenu des résultats satisfaisants. Il n’y a eu aucun résultat négatif. Une analyse de régression logistique simple a montré qu’un angle de flexion préopératoire > 60 degrés (OR 2,7 ; IC à 95 % 0,12 ; 5,28 ; p = 0,040) était significatif pour prédire les plaintes de raccourcissement du pénis avec l’approche de la PTA. Les deux méthodes sont sûres, efficaces et présentent un risque minimal de complications. Conclusions Ainsi, l’efficacité des deux méthodes de traitement est comparable. Cependant, la chirurgie avec l’approche de la PTA n’est pas recommandée chez les patients ayant une courbure initiale de plus de 60 degrés. Mots‑clés Courbure pénienne, Courbure congénitale du Pénis, Corporoplastie, Corporoplastie rotationnelle, Plicature de la Tunique albuginée des Corps caverneux, Rotation corporelle Background age 8.3 years; postpubertal, average age 16.2 years) Penile curvature due to various reasons (congenital or demonstrated comparable long-term results (78% and acquired) is a disease leading to persistent impairment 83% efficacy for the respective groups at 38,7 and 45.1 of copulatory function. The epidemiology is definitively months), which indicates the possibility of successful unclear as there are not enough large-scale researches treatment at any age [7]. available. The most famous work by Yachia et  al. [1 ] Nowadays there are various modifications of TAP by describes a 0.6% chance of birth a boy with penile cur- Nesbit. For example, a comparative study proved the vature. There is also information about a higher inci - technical superiority of the medial dissection of the dence of anomalies – 4 to 10%, based on the data of the neurovascular bundle without excision of the dorsal Birth Defects Monitoring Program (BDMP, USA) and vein over the lateral variant. Meanwhile, the probability data from other authors [2]. The prevalence of acquired of penile shortening, the effectiveness of its straighten - curvature varies from 0.5 to 13% [3]. Many authors do ing, and postoperative numbness of the glans penis did not include curvature less than 20 degrees in the statis- not differ significantly in both groups [8 ]. There are also tics, since it does not affect the copulatory act. modifications without circumcision, which have a simi - There are four main mechanisms of congenital cur - lar high efficiency (96%) and comparable risks of com - vatures development: cutaneous or subcutaneous plications [9, 10]. chord, the disproportion of the corpus cavernosum, or In general, the effectiveness of TAP is about 90–100% congenitally short urethra [2]. The congenital type is in the first postoperative year, typically accompanied by genetic; aberrant expression of COL1A1 and COL6A1 a loss of sensitivity of the glans penis (8.3% in the first affects tunica dartos abnormalities and the severity of year after surgery) and its shortening (26.6–80%; from curvature [4]. 1.5 up to 3–5  cm, depending on the bend) [11–15]. Based on severity the curvature can be insignificant Long-term results indicate a 35–48% risk of curvature (less than 20 degrees), mild (20–30 degrees), moderate recurrence, as well as the risk of anxiety about palpable (30–60 degrees), and severe (more than 60 degrees) [4, 5]. indurations in the plication area [13, 16]. The diagnosis is not difficult and is based on anamne - For the theoretical calculation of the degree of penis sis and assessing the erect penis (based on photographs shortening (L) depending on the curvature angle (Y) of the patient in at least three projections, or with arti- and the girth of the erect penis (C), the authors pro- ficial induction of erection in a hospital) [6 ]. posed a simple formula (L = CY / 180) and a table-nom- There are several approaches to the surgical treatment ogram, which can be useful in planning and discussing of curvature of the penis divided into three large groups: TAP operations [17]. tunica albuginea plication (TAP), corpus cavernosum The significant disadvantages of TAP, such as a signif - rotation (CR), and transplantation of various materials. icant shortening of the penis, the likelihood of repeated Orthoplasty, as a method of removing chords, is not a curvature, decreased sensitivity, and impaired sexual complete medical operation for most cases of curva- function led to the need to develop alternative surgical ture. The plication technique was first described at the techniques. beginning of the 19th century (Philip Syng Physick), but Snow [18] and Kass [19] proposed the dorsal rotation modern TAP methods are based mainly on a modified of the corpora cavernosa [6], and subsequently, Shaeer procedure proposed by Nesbit in 1965 [6]. modified it in three technics: the first [20] and the second Interestingly, the analysis of the surgical treatment [21] include corporotomy, and the third - without it [22]. effectiveness depending on age (prepubertal, average V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 3 of 11 The rotation technique with corporotomy provides length and curvature. Patient complaints were recorded. high efficiency (90%) with an average penis shortening of A similar examination was repeated every 6–12 months. about 5  mm [23]. The modified technique provides high At the planning stage of the study, the required sample efficiency (close to 100%) with insignificant (less than size was calculated using the STATISTICA software for 1  cm) shortening of the penis, regardless of the bending Windows version 10.0. According to the results of several angle, however, there is a slight decrease of the girth of studies presented in the introduction (averaged CR and TAP the erect penis [22, 24, 25]. efficacy indicators, the risk of penile shortening, changes The study aims to compare the effectiveness of the TAP in its girth, etc.), the calculation showed that 8 (the Chi- and CR techniques in the treatment of penile curvature. square method) and 9 (the t-test method) patients in each of the comparison groups will be enough to reproduce the differences in the postoperative state with the probabilities Materials and methods of error of the first and second types equal to 0.05 and 0.2, Research design respectively. Thus, the required total sample size (two com - The clinical trial was approved by the local ethics com - parison groups of patients) should be at least 18 patients. mittee (protocol №2, 15.11.2017) of the Irkutsk State The recruitment of patients who met the inclusion cri - Medical University (ISMU). A prospective, double-blind, teria was carried out prospectively using the continuous randomized (by the method of the blocked fixed randomi - sampling method until the desired sample size was reached. zation) study was carried out in a surgical hospital of the During this period, penile curvature was detected in 46 Irkutsk City Clinical Hospital No. 1 and Saint Luke hospital. patients. Only 35 patients met the study inclusion criteria. The clinical part of the study includes an analysis of All included patients were randomized into two groups surgical treatment results of patients with an established based on the approved study protocol. In both groups, diagnosis of penile curvature from 2017 to 2020. perioperative management was performed according to the The inclusion criteria: adult men with the congeni - fast-track surgery treatment protocol (FTS, approved by the tal or idiopathic penile curvature, ventral / dorsal / lat- ethical committee of the ISMU). The first group (group I) eral, completed IIEF 5 (International Index of Erectile of patients underwent surgical treatment using Shaeer’s cor- Function). Non-inclusion criteria: Peyronie’s disease, poral rotation III [20], and the patients of the second group patient failure, complex curvature, curvature less than 20 (group II) underwent TAP procedure according to Nesbit in degrees, erectile disfunctions, moderate or sever, previ- medial modification with or without circumcision Fig. 1 . ously performed operations for penile curvature. Exclu- sion criteria: changes in the surgical team; the patient dropped out of the study at any stage. Checkpoints The examination included anamnestic (to establish the The primary “hard” endpoints were considered: freedom type of disease, concomitant diseases, etc.), IIEF5 test, from complications Clavien-Dindo > 1. clinical blood and urine, cultural urine test, complete The secondary “soft” checkpoints of clinical efficacy biochemical profile of the blood, ultrasound and tomo - were the data of the subsequent postoperative examina- graphic of the urinary system and corpus cavernosum. tion: normal IIEF indices, the angle of postoperative cur- To clarify the state of the corpora cavernosa and the vature of the penis less than 10 degrees, restoration of the characteristics of blood flow during erection, an ultra - sensitivity of the glans penis, and the last control exami- sound examination of the penis with induction of an nation at least three months after the operation. erection was performed (intracavernous injection of 10 mg of alprostadil into each cavernous body). The measurement of the length and girth of the erect Statistical analysis penis is performed with a flexible measuring tape, or The initial data and surgical treatment results were ana - by the “string-ruler” method from the symphysis to the lyzed using STATISTICA software for Windows version extreme point of the glans penis. The IIFE-5 scale allowed 10.0 (Statsoft, Inc, USA), SPSS Statistics version 23.0 assessing the state of erectile function before surgery and (IBM, USA), and Stata version 16.0 (StataCorp, USA). 3 months after surgery. The curvature angle was meas - The Shapiro-Wilk test helped to verify the hypothesis ured using a protractor. of the normality of features distribution. The Leuven test Upon reaching a month and three months after the allowed verifying the equality of the variances of the dis- surgery, all patients underwent the standard assessment tributions of the features. of the state established by the study protocol: consulta- For descriptive statistics of quantitative normally dis- tion with a urologist, clinical blood and urine tests, ultra- tributed features with equality of variances, there are sound examination of the penis, measurement of its parametric methods: calculation of average values and standard deviations. For quantitative features with a Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 4 of 11 Fig. 1 Block diagram of the study design. Note: Intention-to-treat – those who have passed the assessment for acceptability, not included in the study. Per-protocol – included in the study according to the protocol distribution other than normal and qualitative ordinal feature), nonparametric U-Mann-Whitney test (groups features, there are nonparametric methods: calculating of continuous data with a distribution other than medians and the corresponding interval between the normal). 25th and 75th percentiles (Q1; Q3). For qualitative nomi- In case of statistically significant differences in the nal features, relative frequencies served as a percentage. groups, to overcome the problems of multiple com- To determine the reliability of differences in paired parisons the nonparametric Mann-Whitney test with comparisons, there was the nonparametric McNemar Bonferroni correction allowed performing a pairwise test (nominal data groups); the nonparametric test of comparison of the groups. Wilcoxon signs (ordinal data groups); the paired t-test Simple and multiple logistic regression helped to iden- (groups of continuous data with a normal distribution tify predictor variables for a binary response variable. The of the feature); and the nonparametric test of Wilcoxon predictor variables were selected according to the initial signs (groups of continuous data with a non-normal dis- and postoperative parameters. Cox proportional risks tribution of the feature). regression helped to assess the correlation between one To determine the reliability of differences intergroup or more continuous or categorical variables and the time (independent) comparisons, there was the Chi-square to an adverse event. The significance level for all methods test (nominal data groups), nonparametric Mann-Whit- is p ≤ 0.05. ney U-test (ordinal data groups), Student’s test (groups Comparison of the groups is presented by the compos- of continuous data with a normal distribution of the ite endpoints method [26]. V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 5 of 11 Treatment protocols 5 − 0, cyanoacrylic glue was applied to the wound. In the Perioperative preparation was carried out according to postoperative period, on the first day after surgery, only the ERAS program. Preoperative patient education and NSAIDs (ketoprofen) were used for pain control, it was discussion were conducted by a multidisciplinary team. allowed to consume liquid after 3  h and solid food 6  h Patients were recommended to stop smoking and alcohol after. Infusion therapy was ended with the resumption of cessation for the entire perioperative period. The patient nutrition. The urethra was intraoperatively catheterized, was allowed to consume liquids and carbohydrate mix- the catheter was removed 6  h later. The next day after tures 2  h before surgery, bowels preparing was not per- the surgery, the patient underwent the final assessment, formed – the patient was prescribed a slag-free diet four control blood and urine tests, an ultrasound examina- days before surgery, and premedication of NSAIDs (keto- tion. In the case of a satisfactory condition, the patient profen) was performed. Antibacterial prophylaxis was was discharged. performed once, 30  min before the operation. The pro - tocol of multimodal anesthesia was applied according to Results the decision of the team of anesthesiologists. Of the 35 patients initially included in both comparison All operations were performed with the induction of groups, 13 were subsequently excluded from the study. an erection by injecting saline solution into the cavern- From the group of patients excluded from the study, 5 ous bodies. When performing the plication, the stand- dropped out due to deviations from the study protocol, ard Nesbitt procedure was used, with modifications in and 8 – for personal reasons. Deviations from the proto- several cases: without deglovation, medial variant. Thus, col were conventionally divided into primary, secondary, not all patients underwent penile scalping. Dissection and tertiary (Table 1). of the neurovascular bundle was performed laterally or The primary deviation from the protocol meant a medially. After the tunica albuginea was exposed, the forced change in the treatment protocol before the surgi- necessary volume of plication’s sutures was estimated to cal intervention. For two patients of the first group, we eliminate the curvature. Then stitches were performed on had to change the surgical tactics to plasty of the tunica the marked zones. albuginea with the use of graft due to the complex variant The rotation was carried out according to the Shaeer’s of curvature. corporate rotation III method, a reference to which was Secondary deviations occurred in a single case in the presented earlier. The operation involves the isolation first group and two cases in the second group, due to a of the dorsal neurovascular bundle and the execution of change in intraoperative tactics. For the patient of the first longitudinal colliding separate sutures throughout the group, due to the small bending angle (26 degrees) and his cavernous bodies, which unfold and fix the dorsal sur - wishes, intraoperatively we assessed the prospect of per- faces in the direction of each other. Rotary seams are forming TAP, which was performed. In the second group, applied until the desired result is achieved. a combined TAP correction in combination with buccal Intraoperatively, non-absorbable suture material Pro- graft transplantation was performed intraoperatively due line was used on cavernous bodies, monopolar coagu- to a significant bending angle and complex bending shape. lation was not used. The skin suture by the Monocryl There were no tertiary deviations from the study protocol. Table 1 Analysis of deviations from the research protocol Deviations Characteristic Group I Group II P CR TAP (n = 17) (n = 18) Primary deviations Different treatment method has been chosen, n (%) 2 (11.7%) 0 (0%) 0.157 No primary deviations from protocol, n 15 18 - Secondary deviations Intraoperative change of tactics, n (%) 1 (6.6%) 2 (11.1%) 0.685 No primary and secondary deviations from the protocol, n 14 16 - Tertiary deviations Changing the diagnosis, n (%) 0 (0%) 0 (0%) - Protocol feasibility, n (%) 14(82.3) 16(88.8) 0.878 To determine the value of P, a Chi-square comparison was used CR corporal rotation, TAP tunica albuginea plication Primary deviations - before the surgical intervention Secondary deviations - a change in intraoperative tactics Tertiary deviations – after the surgical intervention Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 6 of 11 The indicator of the likelihood of completing the treat - Table 2 Comparative characteristics of patients in comparison groups before surgery ment protocol, considering all three groups of deviations in this sample, was 82.3% and 88.8% for clinical groups Parameters Group I Group II Р I and II (p = 0.878), respectively. Due to such forced CR TAP (n = 9) (n = 13) deviations from the study protocol, these patients were excluded from the analysis according to the protocol General: (per-protocol) as not meeting the study criteria. Age, years 27.4 (±9.8) 28.2 (±10.27) 0.858 There were 5 (21.7%) patients of group I and 3 (13.0%) Height, cm 175.7 (±4.4) 174.4 (±8.5) 0.676 of group II who refused to participate in the study at any Weight, kg 71.7 (±8.4) 71.5 (±12.4) 0.960 stage. The completeness of clinical follow-up for patients Indicators of penile status: in both groups was 39.1% (9 cases) for group I and 56.5% Penile curvature angle, degrees 48.8 (±17.1) 48.2 (±14.9) 0.924 (13 cases) for group II. The analysis of the effectiveness of Length of an erect penis, cm 16.7 (±1.9) 16.1 (±2.2) 0.473 postoperative follow-up demonstrated its comparability The girth of the erect penis, cm 13.3 (±1.6) 12.8 (±1.48) 0.523 in both groups (by the Chi-squared test; p = 0.482). Vertical curvature, n (%) 7 (77.7%) 9 (69.2%) 0.218 u Th s, the final clinical analysis included 22 patients Congenital curvature, n (%) 7 (77.7%) 9 (69.2%) 0.218 (per-protocol) meeting all the study criteria. Of these, 2 Anamnesis: groups of patients were formed. The patients of the CR Smoking, n (%) 4 (44.4%) 8 (61.5%) 0.664 method (n = 9, group I) and the patients of the TAP pro- Alcohol abuse, n (%) 1 (11.1%) 1 (7.6%) 0.802 cedure (n = 13, group II). Allergy, n (%) 2 (22.2%) 3 (23%) 0.970 Table 2 presents comparative data on the initial param- IIEF5 before surgery, scores 21 (21;22) 20 (20;22) 0.300 eters of patients in the study groups. To determine the value of P, the Student’s criterion was used (in groups of The angle of penile curvature was from a minimum continuous data with a normal distribution of the trait; described as mean of 22 degrees to a maximum of 88 degrees, the length +/-SD;), chi-square criterion (in groups of nominal data; described as n (%)), nonparametric Mann-Whitney U-criterion (in groups of continuous data with a of the erect penis, respectively, 12.2–21.1  cm, and girth distribution of different from normal; denoted as median and 25–75 quartiles.) – 9.7–16.8 cm. IIEF5 International Index of Erectile Function All cases of horizontal penile curvature among the CR corporal rotation, TAP tunica albuginea plication enrolled patients were acquired. Analysis of the causes of the curvature (the study did not include patients with Pey- ronie’s disease) showed that in most cases they were idi- Data analysis showed that after CR there is a slight opathic or arose because of various medical interventions. shortening (on average 6 mm) and a decrease (on average u Th s, the analysis of the main characteristics of patients of 12  mm) in the girth of the erect penis (p < 0,05). CR in the comparison groups demonstrated their compara- can successfully eliminate curvature and improve copu- bility (p > 0.05). latory function (change in both parameters p < 0.001). The effectiveness of the treatment was assessed accord - TAP caused significant shortening (on average 24  mm, ing to several criteria: penile curvature no more than 10 p = 0.006) and a slight decrease (on average 3 mm) in the degrees, IIEF5 ≥ 21 points, satisfaction with the treat- girth of the erect penis. TAP can successfully eliminate ment according to the patient’s subjective perception, the curvature and improve copulatory function (change no subjective sensation of penile shortening, no subjec- in both parameters p < 0.001). tive sensation of changes in the thickness or shape of the Table  5 shows the comparative characteristics of the penis. Table 3 presents the treatment results divided into indicators of the postoperative state of patients in the two groups. comparison groups. All surgeries in both groups were successful according to the endpoints criteria. In the early and late postopera- Table 3 Evaluation of treatment outcomes using the composite tive periods, there were no cases of mortality in the two endpoints method groups. In the postoperative period, there were no com- Parameter Successful Satisfactory plications of anesthesia or deterioration of the general somatic status. The need for artificial ventilation or res - No curvature > 10 degrees + - piratory support did not arise in any case in the compari- IIEF5 ≥ 21 points + - son groups. Also, there were no cases of heart failure that Shortening of the penis, subjective + - required inotropic support. Table  4 presents the dynam- Changing the thickness or shape of the + - ics of changes in the parameters of the penile state and penis, subjective functional status before and after the surgery. Satisfaction with treatment + - IIEF5 International Index of Erectile Function V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 7 of 11 Table 4 Dynamics of the parameters of the state of the penis and functional status in the comparison groups before and after surgery Parameter. I group; CR (n = 9) Before 3 months after Difference Р Length of erect penis, cm 16.7 (± 1.9) 16.1 (± 1.8) -0.6 (± 0.07) 0.470 Girth of the erect penis, cm 13.3 (± 1.6) 12.1 (± 1.4) -1.2 (± 0.14) 0.119 The angle of the penile curva- 48.8 (± 17.1) 1 (1;1) -47.5 (± 15.9) < 0.001 ture, degrees IIEF-5, points 21 (21;22) 25 (25;25) +4 (3;4) < 0.001 Parameter. II group; TAP Initially Finally Difference Р (n = 13) Length of erect penis, cm 16.1 (± 2.2) 13.6 (± 1.8) -2.4 (± 0.8) 0.006 Girth of the erect penis, cm 12.8 (± 1.48) 12.4 (± 1.7) -0.3 (± 0.05) 0.585 The angle of the penile curva- 48.2 (± 14.9) 1 (1;1) -47.4 (± 14.7) < 0.001 ture, degrees IIEF-5, points 21 (20;22) 25 (25;25) +5 (3;5) < 0.001 To determine the value of P, the Student’s criterion was used (in groups of continuous data with a normal distribution of the trait; described as mean +/-SD;), chi- square criterion (in groups of nominal data; described as n (%)), nonparametric Mann-Whitney U-criterion (in groups of continuous data with a distribution of different from normal; denoted as median and 25–75 quartiles.) CR corporal rotation, TAP tunica albuginea plication IIEF5 International Index of Erectile Function The results analysis demonstrated that there were no The analysis of the comparative intergroup treatment significant complications in the postoperative period. efficacy based on the criteria established in the study The only complication in the early postoperative period showed good treatment results for 8 (88.8%) patients of was the occurrence of a small subcutaneous hematoma group I and 9 (69.2%) patients in group II (p = 0.577), in a patient of group I; evacuating the hematoma during according to Table 6. Satisfactory for everyone else. There bandaging and using tight bandaging of the penis for one were no negative outcomes. day solved the problem. Univariate and multivariate logistic regression analysis On average, all patients stayed for one day in the hos- made it possible to determine the predictors of compli- pital, which meets the protocol criteria for Fast-track cations (Table  6). The table shows the results with Chi- surgery. There were no changes in the hospital stay with squared test. either treatment. A simple (univariate) logistic regression analysis among Comparative analysis of objective and subjective 22 patients of both comparison groups, demonstrated parameters (length and girth of the erect penis) showed the significance in the prognosis of complaints of penile a significant difference in the comparison groups. Thus, shortening only by the preoperative curvature angle > 60 after CR, there is a relatively decrease in the girth of degrees in group II (OR 2.7; 95% CI 0.12; 5, 28; p = 0.040). the penis (p < 0.05), and after TAP, there is a significant Based on this ratio, the degree of influence of the predictor decrease in the length of the penis (p < 0.05). on the risk of shortening was calculated. Consequently, a Numbness of the glans penis was found in both com- previous penile curvature > 60 degrees increases the likeli- parison groups. This parameter in the short and long hood of complaints on penis shortening by 2.7. terms did not differ in the comparison groups (in both Obtained results helped to construct a model for pre- cases, p > 0.5). A palpable induration in the surgical area dicting the occurrence of complaints of penile shortening was detected only in the TAP group, with a no statistical in multivariate regression analysis (selection from predic- difference (p = 0.057). tor factors with a significance level of p < 0.1). There were Subjective assessment of the treatment results, as well as no significant predictors. the condition of the penis in the postoperative period, did Logistic regression analysis of the risk of changes in girth not differ in both groups (p > 0.05 for all three comparisons). or shape of the penis was similar. Penile length over 16 cm All patients were followed up for at least three months after surgery was a significant predictor (OR 0.77; 95% CI after surgery. For group I, the average observation period 0.07; 1.47; p = 0.029). For predictors of development of pal- was 682 days with a 95% CI of 217–617 days (maximum pable penile induration, the following factors were signifi - period of 1116 days). For group II, the average observa- cant: weight (OR 0.17; 95% CI 0.02; 0.33; p = 0.027), change tion period was 815 days with a 95% CI of 281–647 days in penile length (OR 2.1; 95% CI 0.32; 4.04; p = 0.021), short- (maximum period of 1276 days). ening > 2 cm (OR 2.7; 95% CI 0.28; 5.13; p = 0.029) and post- operative girth (OR 0.88; 95% CI 0.08; 1.68; p = 0.031). Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 8 of 11 Table 5 Comparison of sample parameters of treatment results Indicator Group I Group II Р CR TAP (n = 9) (n = 13) Average duration of hospitalization, days 1 (1;1) 1 (1;1) 1.0 Postoperative condition of the penis: Shortening of the penis > 1 cm, n (%) 0 (0%) 12 (92.3%) 0.009 Reducing penile girth > 1 cm, n (%) 8 (88.8%) 0 (0%) 0.003 Changing the length of the penis, cm -0.6 (±0.07) -2.4 (±0.8) <0.001 Changing of the girth of the penis, cm -1.2 (±0.14) -0.3 (±0.05) <0.001 Post-operative IIEF5, scores 25 (25;25) 25 (25;25) 0.946 Feeling numb, n (%) Up to 3 months after surgery 1 (11.1%) 3 (23.0%) 0.547 More than 3 months after surgery 1 (11.1%) 2 (15.3%) 0.801 Infectious complications, n (%) 0 (0) 0 (0) 0 Surgical seam insolvency, n (%) 0 (0) 0 (0) 0 Postoperative hematoma, n (%) 1 (11.1%) 0 (0%) 0.243 Palpable induration, n (%) 0(0%) 6 (46.1%) 0.057 Subjective patient satisfaction, n (%) 9 (100%) 11(84.6%) 0.789 Subjective shortening of the penis, n (%) 0 (0%) 4 (30.7%) 0.113 Subjective reduction of girth or change of penile shape, n (%) 1 (11.1%) 0 (0%) 0.243 To determine the value of P, the Student’s criterion was used (in groups of continuous data with a normal distribution of the trait; described as mean +/-SD;), chi- square criterion (in groups of nominal data; described as n (%)), nonparametric Mann-Whitney U-criterion (in groups of continuous data with a distribution of different from normal; denoted as median and 25–75 quartiles.) IIEF5 - International Index of Erectile Function CR corporal rotation, TAP tunica albuginea plication Multivariate analysis did not show reliable results as a reverse deformity/curvature of the penis in the post- (p > 0,05 for all tests). operative period, caused by spontaneous rupture of the It should be noted that both methods of treatment have thread or untied knot [16, 28]. During the study period, zero operating and hospital mortality and a low incidence there were no cases of reverse deformity, a single devel- of postoperative complications. Both methods of treatment opment of postoperative hematoma did not require reop- are highly effective and safe for penile curvature correction. eration and was eliminated conservatively. The probability of numbness of the glans penis was comparable in both comparison groups. Numbness resolved on its own over Discussion time, which also correlates with the data of other authors The average normal size of an erect penis is a length of [8]. Plication revealed several cases of subjective com- 13.1 (± 1.66) cm and a circumference of 11.6 (± 1.10) plaints of the presence of seals, which, nevertheless, did cm [27]. Currently, the criterion for the effectiveness not differ significantly for the comparison groups [29, 30]. of surgical treatment is a relatively straight penis (bend However, the authors believe that this conclusion is not less than 20 degrees, which does not prevent the copula- accurate and is due to the small sample size. tory act). A shortening of the penis of less than 1.5 cm is When comparing the results, a statistically significant also a favorable outcome [5, 15]. In the presented study, difference in the parameters of the penis was noted. achieved results indicate the effective and safe use of However, these changes did not affect the subjective per - both methods for correcting penile curvature. ception of the results of treatment. In general, the data Typical complications of any of the curvature correc- are consistent with the results of the Shaeer CR surgery tion methods are the postoperative hematomas (6.5%), [22] and various TAP modifications [11–13]. painful or unpleasant indurations in the plication or rota- Logistic regression analysis revealed interesting and tion areas (1.4–73%), changes in the sensitivity of the debatable results. There is no doubt about the reliability glans penis (0–37%), shortening of the penis (up to 80%), of the risk of significant shortening of the penis after pli - wound infection (1.4%) and some more rare complica- cation in patients with a bend of more than 60 degrees. tions [15, 16]. There can be a technical complication such V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 9 of 11 Table 6 Predictors of complications Factor Sign Univariate analysis Multivariate analysis χ OR (95% CI) Р OR (95% CI) Р Subjective shortening of the erect penis. Height 6.65 0.28(-0.002;0.57) 0.052 0.6(-256;22.07) 0.099 Multifactor logit-regression: Weight 13.99 0.49(-0.09;1.0) 0.101 - ‑ χ = 13.63; р = 0.0035 Penile curvature before 3.7 0.07 (-0.009:0.15) 0.083 -0.04(-0.25;0.1) 0.709 Angle before surge ry > 60 5.06 2.7(0.12;5.28) 0.040 6.8(-1.75;15.4) 0.119 Length before > 15.5 cm 2.56 0.42(-0.11;0.96) 0.126 - - Changing the length > 2 cm 16.72 8.9(-11.2;29.1) 0.384 - - Girth before surgery 2.61 0.52(-0.14;1.19) 0.123 - - IIEF5 before surgery 1.19 -0.40(-1.13;0.33) 0.283 - - Allergy 2.82 -1.4(-3.2;0.3) 0.113 - - Subjective reduction of girth or shape of the Curvature angle after surgery 1.38 0.47(-0.38;1.33) 0.278 - - erect penis. Length after surgery > 16 cm 8.08 0.77(0.07;1.47) 0.029 - - Change in length > 1cm 20.59 -8.4 (-18.1:1.15) 0.085 - - Girth before surgery 1.04 0.27(-0.26;0.80) 0.318 - - Palpable induration Height 5.93 0.22(-0.009;0.45) 0.060 - - Weight 8.23 0.17(0.02;0.33) 0.027 - - Horizontal curvature 2.02 0.03 (-0.02:0.09) 0.158 - - Penile curvature before 1.06 -0.05(-0.1;0.001) 0.310 - - Angle before surgery > 60 2.02 1.46(-0.56;3.5) 0.158 - - Length before surgery 3.56 0.45(-0.05;0.96) 0.082 - - Changing length 12.19 2.1(0.32;4.04) 0.021 - - Shortening > 2 cm 6.37 2.7(0.28;5.13) 0.029 - - Girth before surgery 3.65 0.57(-0.06;1.2) 0.079 - - Girth after surgery 6.73 0.88(0.08;1.68) 0.031 - - This conclusion is consistent with the works of other the works presented in more detail, the authors con- authors [5, 15]. We consider the influence of the length of cluded about a different method for calculating the the penis more than 16 cm on the risk of changes in the length of an erect penis, which provides a significant dif - girth or shape of the penis after surgery, and the effect of ference in TAP results. Thus, most authors before the weight on the risk of developing palpable indurations as surgery measure the length of the penis using a straight doubtful since there is only an indirect logical connec- metal ruler, which gives unreliable results for the curve of tion. The influence of plication on the absolute value of the midline of the penis [32]. In addition, the authors do the girth of the penis after surgery are natural. However, not describe the endpoints of measurement (glans to the there is a need for further studies with a larger sample. skin of the pubis, or glans to the symphysis), which has Several researchers [14, 16] do not report the linear the potential to influence (with different measurement dimensions of the penile shortening, relying on the sub- techniques in different patients or the same patient at dif - jective perception of patients in the postoperative period, ferent stages of the study) the results within the frame- which is a less reliable presentation of treatment results work of even one study [33]. It means that there is a need in comparison with a complex subjective and objective for a more detailed presentation in scientific works of the assessment. Meanwhile, the results with accurate linear applied measurement methods, as well as the use of more data in some cases indicate the absence of a significant reliable measurement with a flexible tape, measuring change in length after TAP procedures [31]. Such works thread, or in another similar way. raise questions, reporting a slight objective decrease in The partial mobilization of the urethra to release the the postoperative length of the penis. On the contrary, ventral parts of the corpora cavernosa can presumably some studies indicate a more significant decrease in be the solution to the problem of reducing the girth of length after TAP from 0 to 2.5-5  cm, depending on the the penis after rotational operations. Thus, it can help initial curvature angle and the type of curvature (appar- to solve the problem of deformation of the corpus cav- ently, the ventral version provides a more significant ernosum during its rotation, but this problem requires a shortening) with TAP procedures [5, 15, 32]. Analyzing separate study. In this case, the efficiency of straightening Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 10 of 11 IIEF5 International Index of Erectile Function directly depends on the length of the rotation. That is, ISMU Irkutsk State Medical University for this surgery, the more significant the curvature, the TAP tunica albuginea plication greater the mobilization of the neurovascular bundle and Acknowledgements the implementation of many retaining sutures. Not applicable. Separately, the authors would like to note that a high subjective assessment of the results of treatment, even Authors’ contributions All authors contributed to the study conception and design. Material prepara- with the shortening of the penis, is probably due to a sig- tion, data collection and analysis were performed by Vladimir Vorobev, Andrey nificant improvement in copulatory function, leveling Sherbatykh, Olga Baklanova, and Stepan Sidorov. The first draft of the manu- other negative sensations. However, copulatory function script was written by Vladimir Beloborodov, Sergei Popov and Alexey Kalyagin. All authors read and approved the final manuscript. was not evaluated in the study. u Th s, the results and their comparison with the data Funding presented earlier in scientific publications were analyzed. The authors received no financial support for the research, authorship, and/or publication of this article. Comparative analysis is difficult due to the small number of works on the problem of penile curvature without Pey- Availability of data and materials ronie’s disease, as well as on the search for predictors of Data will be available on request. a specific type of complications after performing TAP or CR. There is a need for further study in larger samples Declarations and a comparison of the obtained data with the results Ethics approval and consent to participate of other authors. A significant advantage of the work is The research was conducted ethically in accordance with the World Medical an isolated analysis (no relapse, one team of surgeons, Association Declaration of Helsinki. The research was approved by the local ethics committees of Irkutsk State Medical University. refusal to re-enroll in the study, etc.) analysis of the Informed consent was signed by participants. influence of various factors on the likelihood of postop - erative complications. Limitations of the research: rela- Consent for publication Not applicable. tively small samples, the average postoperative follow-up period of less than five years, single-center study. Competing interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Conclusion Both methods are safe, effective, and bring minimal Author details risks of complications. Both surgical techniques lead to Department of General Surgery, Irkutsk State Medical University, Irkutsk, Russian Federation. Department of Theoretical Surgery, Irkutsk State Medical a change in the geometry of the erect penis: they allow University, Irkutsk, Russian Federation. Department of Introduction to Internal to eliminate the curvature but are accompanied by short- 4 Medicine, Irkutsk State Medical University, Irkutsk, Russian Federation. Depar t- ening (Plication is more pronounced than Rotation) or ment of Urology, GBUZ State Oncology Hospital, Irkutsk, Russian Federation. Department of Urology, Irkutsk State Medical University, Irkutsk, Russian a decrease in grith (Rotation is more pronounced than Federation. Plication). Patients should be warned about the conse- quences, and the method of surgical technique should be Received: 4 January 2023 Accepted: 11 January 2023 discussed with the presentation of possible outcomes. Based on the results, important criteria for the selec- tion of patients are formulated: Plication techniques are References not recommended for patients with pronounced curva- 1. Yachia D, Beyar M, Aridogan IA, Dascalu S. The incidence of congenital ture, or initial dissatisfaction with the size of the penis; penile curvature. J Urol. 1993;150(5):1478–9. https:// doi. org/ 10. 1016/ Rotation techniques require the greater mobilization of S0022- 5347(17) 35816-0. 2. Montag S, Palmer LS. 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World J Urol. 2003;20(6):350–5. https:// doi. org/ 10. 1007/ penile curvature who present with worsening penile deformity. World J s00345- 002- 0307-y. Urol. 2020;38(2):305–14. https:// doi. org/ 10. 1007/ s00345- 019- 02787-7. 33. Habous M, Tealab A, Williamson B, Binsaleh S, El Dawy S, Mahmoud S, 14. Hudak SJ, Morey AF, Adibi M, Bagrodia A. Favorable patient reported et al. Erect penile dimensions in a cohort of 778 Middle Eastern men: outcomes after penile plication for wide array of peyronie disease abnor- establishment of a nomogram. J Sex Med. 2015;12(6):1402–146. https:// malities. J Urol. 2013;189(3):1019–24. https:// doi. org/ 10. 1016/j. juro. 2012. doi. org/ 10. 1111/ jsm. 12894. 09. 085. 15. Savoca G, Trombetta C, Ciampalini S, De Stefani S, Buttazzi L, Belgrano Publisher’s Note E. Long-term results with Nesbit’s procedure as treatment of Peyronie’s Springer Nature remains neutral with regard to jurisdictional claims in pub- disease. Int J Impot Res. 2000;12(5):289–93. https:// doi. org/ 10. 1038/ sj. ijir. lished maps and institutional affiliations. 39006 12. 16. Makovey I, Higuchi TT, Montague DK, Angermeier KW, Wood HM. Congenital penile curvature: update and management. Curr Urol Rep. 2012;13(4):290–7. https:// doi. org/ 10. 1007/ s11934- 012- 0257-x. 17. Parnham AS, Parnham SM, Pearce I. A mathematical model to predict the loss of length in patients undergoing plication corporoplasty for Peyro- nie’s disease. J Clin Urol. 2017;10(1):5–8. https:// doi. org/ 10. 1177/ 20514 15816 671085. 18. Snow BW. Transverse corporeal plication for persistent chordee. Urology. 1989;34:360–1. https:// doi. org/ 10. 1016/ 0090- 4295(89) 90442-1. 19. Kass EJ. Dorsal corporeal rotation: an alternative technique for the management of severe chordee. J Urol. 1993;50:635–6. https:// doi. org/ 10. 1016/ s0022- 5347(17) 35570-2. 20. Shaeer O. Correction of penile curvature by rotation of the corpora caver- nosa: a case report. 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Modern research in the field of microen- thorough peer review by experienced researchers in your field capsulation (review). Drug Dev Registr. 2021;10(2):50–61. https:// doi. org/ 10. 33380/ 2305- 2066- 2021- 10-2- 50- 61. rapid publication on acceptance 25. Flisyuk EV, Belokurov SS, Narkevich IA, Flisyuk OM, Ivkin DYu. The support for research data, including large and complex data types analysis of process of crushing in the vibrocavitational homog- • gold Open Access which fosters wider collaboration and increased citations enizer. Drug Dev Registr. 2020;9(4):53–8. https:// doi. org/ 10. 33380/ 2305- 2066- 2020-9- 4- 53- 58. maximum visibility for your research: over 100M website views per year 26. Hara H, van Klaveren D, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Takahashi K, Capodanno D, Onuma Y, Serruys PW. At BMC, research is always in progress. Statistical methods for composite endpoints. 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The effectiveness of penile curvature treatment by cavernous body rotation and plication of the tunica albuginea

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Abstract

Background There are several approaches to the surgical treatment of the penile curvature conditionally divided into three large groups: tunica albuginea plication ( TAP), corpus cavernosum rotation (CR), and transplantation of various materials. The study aims to compare the effectiveness of TAP and CR techniques in the treatment of penile curvature. There was a prospective randomized study of the effectiveness of surgical treatment of patients with an established diagnosis of the penile curvature from 2017 to 2020 in Irkutsk, Russian Federation. The final analysis of the results included 22 cases. Results The analysis of the comparative intergroup effectiveness of the treatment performed based on the criteria established in the study showed good treatment results in 8 (88.8%) patients in the CR group and 9 (69.2%) patients in the TAP group (p = 0.577). The other patients obtained satisfactory results. There were no negative outcomes. Simple logistic regression analysis showed that the preoperative flexion angle > 60 degrees (OR 2.7; 95% CI 0.12; 5.28; p = 0.040) was significant in predicting the complaints of penile shortening during TAP. Both methods are safe, effec- tive, and bring minimal risk of complications. Conclusion Thus, the effectiveness of both treatment methods is comparable. However, TAP surgery is not recom- mended for patients with an initial curvature of more than 60 degrees. Keywords Penile curvature, Congenital curvature of the penis, Corporoplasty, Rotational corporoplasty, Plication of the tunica albuginea of the corpora cavernosa, Corporal rotation Résumé Contexte Il existe plusieurs approches du traitement chirurgical de la courbure pénienne, divisées en trois grands groupes : plicature de la tunique albuginée (PTA), rotation du corps caverneux (RCC) et transplantation de divers matériaux. La présente étude vise à comparer l’efficacité des techniques PTA et RCC dans le traitement de la courbure du pénis. Il s’agit d’une étude prospective randomisée de l’efficacité du traitement chirurgical de patients ayant un diagnostic établi de courbure du pénis, de 2017 à 2020 à Irkoutsk, en Fédération de Russie. L’analyse finale des résul- tats comprend 22 cas. *Correspondence: Vladimir Vorobev vlvorobev7@rambler.ru Full list of author information is available at the end of the article © The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http:// creat iveco mmons. org/ licen ses/ by/4. 0/. The Creative Commons Public Domain Dedication waiver (http:// creat iveco mmons. org/ publi cdoma in/ zero/1. 0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 2 of 11 Résultats L’analyse de l’efficacité comparative intergroupe du traitement effectué sur la base des critères établis dans l’étude, a montré de bons résultats du traitement chez 8 (88,8%) patients du groupe RCC et 9 (69,2%) patients du groupe PTA (p = 0,577). Les autres patients ont obtenu des résultats satisfaisants. Il n’y a eu aucun résultat négatif. Une analyse de régression logistique simple a montré qu’un angle de flexion préopératoire > 60 degrés (OR 2,7 ; IC à 95 % 0,12 ; 5,28 ; p = 0,040) était significatif pour prédire les plaintes de raccourcissement du pénis avec l’approche de la PTA. Les deux méthodes sont sûres, efficaces et présentent un risque minimal de complications. Conclusions Ainsi, l’efficacité des deux méthodes de traitement est comparable. Cependant, la chirurgie avec l’approche de la PTA n’est pas recommandée chez les patients ayant une courbure initiale de plus de 60 degrés. Mots‑clés Courbure pénienne, Courbure congénitale du Pénis, Corporoplastie, Corporoplastie rotationnelle, Plicature de la Tunique albuginée des Corps caverneux, Rotation corporelle Background age 8.3 years; postpubertal, average age 16.2 years) Penile curvature due to various reasons (congenital or demonstrated comparable long-term results (78% and acquired) is a disease leading to persistent impairment 83% efficacy for the respective groups at 38,7 and 45.1 of copulatory function. The epidemiology is definitively months), which indicates the possibility of successful unclear as there are not enough large-scale researches treatment at any age [7]. available. The most famous work by Yachia et  al. [1 ] Nowadays there are various modifications of TAP by describes a 0.6% chance of birth a boy with penile cur- Nesbit. For example, a comparative study proved the vature. There is also information about a higher inci - technical superiority of the medial dissection of the dence of anomalies – 4 to 10%, based on the data of the neurovascular bundle without excision of the dorsal Birth Defects Monitoring Program (BDMP, USA) and vein over the lateral variant. Meanwhile, the probability data from other authors [2]. The prevalence of acquired of penile shortening, the effectiveness of its straighten - curvature varies from 0.5 to 13% [3]. Many authors do ing, and postoperative numbness of the glans penis did not include curvature less than 20 degrees in the statis- not differ significantly in both groups [8 ]. There are also tics, since it does not affect the copulatory act. modifications without circumcision, which have a simi - There are four main mechanisms of congenital cur - lar high efficiency (96%) and comparable risks of com - vatures development: cutaneous or subcutaneous plications [9, 10]. chord, the disproportion of the corpus cavernosum, or In general, the effectiveness of TAP is about 90–100% congenitally short urethra [2]. The congenital type is in the first postoperative year, typically accompanied by genetic; aberrant expression of COL1A1 and COL6A1 a loss of sensitivity of the glans penis (8.3% in the first affects tunica dartos abnormalities and the severity of year after surgery) and its shortening (26.6–80%; from curvature [4]. 1.5 up to 3–5  cm, depending on the bend) [11–15]. Based on severity the curvature can be insignificant Long-term results indicate a 35–48% risk of curvature (less than 20 degrees), mild (20–30 degrees), moderate recurrence, as well as the risk of anxiety about palpable (30–60 degrees), and severe (more than 60 degrees) [4, 5]. indurations in the plication area [13, 16]. The diagnosis is not difficult and is based on anamne - For the theoretical calculation of the degree of penis sis and assessing the erect penis (based on photographs shortening (L) depending on the curvature angle (Y) of the patient in at least three projections, or with arti- and the girth of the erect penis (C), the authors pro- ficial induction of erection in a hospital) [6 ]. posed a simple formula (L = CY / 180) and a table-nom- There are several approaches to the surgical treatment ogram, which can be useful in planning and discussing of curvature of the penis divided into three large groups: TAP operations [17]. tunica albuginea plication (TAP), corpus cavernosum The significant disadvantages of TAP, such as a signif - rotation (CR), and transplantation of various materials. icant shortening of the penis, the likelihood of repeated Orthoplasty, as a method of removing chords, is not a curvature, decreased sensitivity, and impaired sexual complete medical operation for most cases of curva- function led to the need to develop alternative surgical ture. The plication technique was first described at the techniques. beginning of the 19th century (Philip Syng Physick), but Snow [18] and Kass [19] proposed the dorsal rotation modern TAP methods are based mainly on a modified of the corpora cavernosa [6], and subsequently, Shaeer procedure proposed by Nesbit in 1965 [6]. modified it in three technics: the first [20] and the second Interestingly, the analysis of the surgical treatment [21] include corporotomy, and the third - without it [22]. effectiveness depending on age (prepubertal, average V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 3 of 11 The rotation technique with corporotomy provides length and curvature. Patient complaints were recorded. high efficiency (90%) with an average penis shortening of A similar examination was repeated every 6–12 months. about 5  mm [23]. The modified technique provides high At the planning stage of the study, the required sample efficiency (close to 100%) with insignificant (less than size was calculated using the STATISTICA software for 1  cm) shortening of the penis, regardless of the bending Windows version 10.0. According to the results of several angle, however, there is a slight decrease of the girth of studies presented in the introduction (averaged CR and TAP the erect penis [22, 24, 25]. efficacy indicators, the risk of penile shortening, changes The study aims to compare the effectiveness of the TAP in its girth, etc.), the calculation showed that 8 (the Chi- and CR techniques in the treatment of penile curvature. square method) and 9 (the t-test method) patients in each of the comparison groups will be enough to reproduce the differences in the postoperative state with the probabilities Materials and methods of error of the first and second types equal to 0.05 and 0.2, Research design respectively. Thus, the required total sample size (two com - The clinical trial was approved by the local ethics com - parison groups of patients) should be at least 18 patients. mittee (protocol №2, 15.11.2017) of the Irkutsk State The recruitment of patients who met the inclusion cri - Medical University (ISMU). A prospective, double-blind, teria was carried out prospectively using the continuous randomized (by the method of the blocked fixed randomi - sampling method until the desired sample size was reached. zation) study was carried out in a surgical hospital of the During this period, penile curvature was detected in 46 Irkutsk City Clinical Hospital No. 1 and Saint Luke hospital. patients. Only 35 patients met the study inclusion criteria. The clinical part of the study includes an analysis of All included patients were randomized into two groups surgical treatment results of patients with an established based on the approved study protocol. In both groups, diagnosis of penile curvature from 2017 to 2020. perioperative management was performed according to the The inclusion criteria: adult men with the congeni - fast-track surgery treatment protocol (FTS, approved by the tal or idiopathic penile curvature, ventral / dorsal / lat- ethical committee of the ISMU). The first group (group I) eral, completed IIEF 5 (International Index of Erectile of patients underwent surgical treatment using Shaeer’s cor- Function). Non-inclusion criteria: Peyronie’s disease, poral rotation III [20], and the patients of the second group patient failure, complex curvature, curvature less than 20 (group II) underwent TAP procedure according to Nesbit in degrees, erectile disfunctions, moderate or sever, previ- medial modification with or without circumcision Fig. 1 . ously performed operations for penile curvature. Exclu- sion criteria: changes in the surgical team; the patient dropped out of the study at any stage. Checkpoints The examination included anamnestic (to establish the The primary “hard” endpoints were considered: freedom type of disease, concomitant diseases, etc.), IIEF5 test, from complications Clavien-Dindo > 1. clinical blood and urine, cultural urine test, complete The secondary “soft” checkpoints of clinical efficacy biochemical profile of the blood, ultrasound and tomo - were the data of the subsequent postoperative examina- graphic of the urinary system and corpus cavernosum. tion: normal IIEF indices, the angle of postoperative cur- To clarify the state of the corpora cavernosa and the vature of the penis less than 10 degrees, restoration of the characteristics of blood flow during erection, an ultra - sensitivity of the glans penis, and the last control exami- sound examination of the penis with induction of an nation at least three months after the operation. erection was performed (intracavernous injection of 10 mg of alprostadil into each cavernous body). The measurement of the length and girth of the erect Statistical analysis penis is performed with a flexible measuring tape, or The initial data and surgical treatment results were ana - by the “string-ruler” method from the symphysis to the lyzed using STATISTICA software for Windows version extreme point of the glans penis. The IIFE-5 scale allowed 10.0 (Statsoft, Inc, USA), SPSS Statistics version 23.0 assessing the state of erectile function before surgery and (IBM, USA), and Stata version 16.0 (StataCorp, USA). 3 months after surgery. The curvature angle was meas - The Shapiro-Wilk test helped to verify the hypothesis ured using a protractor. of the normality of features distribution. The Leuven test Upon reaching a month and three months after the allowed verifying the equality of the variances of the dis- surgery, all patients underwent the standard assessment tributions of the features. of the state established by the study protocol: consulta- For descriptive statistics of quantitative normally dis- tion with a urologist, clinical blood and urine tests, ultra- tributed features with equality of variances, there are sound examination of the penis, measurement of its parametric methods: calculation of average values and standard deviations. For quantitative features with a Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 4 of 11 Fig. 1 Block diagram of the study design. Note: Intention-to-treat – those who have passed the assessment for acceptability, not included in the study. Per-protocol – included in the study according to the protocol distribution other than normal and qualitative ordinal feature), nonparametric U-Mann-Whitney test (groups features, there are nonparametric methods: calculating of continuous data with a distribution other than medians and the corresponding interval between the normal). 25th and 75th percentiles (Q1; Q3). For qualitative nomi- In case of statistically significant differences in the nal features, relative frequencies served as a percentage. groups, to overcome the problems of multiple com- To determine the reliability of differences in paired parisons the nonparametric Mann-Whitney test with comparisons, there was the nonparametric McNemar Bonferroni correction allowed performing a pairwise test (nominal data groups); the nonparametric test of comparison of the groups. Wilcoxon signs (ordinal data groups); the paired t-test Simple and multiple logistic regression helped to iden- (groups of continuous data with a normal distribution tify predictor variables for a binary response variable. The of the feature); and the nonparametric test of Wilcoxon predictor variables were selected according to the initial signs (groups of continuous data with a non-normal dis- and postoperative parameters. Cox proportional risks tribution of the feature). regression helped to assess the correlation between one To determine the reliability of differences intergroup or more continuous or categorical variables and the time (independent) comparisons, there was the Chi-square to an adverse event. The significance level for all methods test (nominal data groups), nonparametric Mann-Whit- is p ≤ 0.05. ney U-test (ordinal data groups), Student’s test (groups Comparison of the groups is presented by the compos- of continuous data with a normal distribution of the ite endpoints method [26]. V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 5 of 11 Treatment protocols 5 − 0, cyanoacrylic glue was applied to the wound. In the Perioperative preparation was carried out according to postoperative period, on the first day after surgery, only the ERAS program. Preoperative patient education and NSAIDs (ketoprofen) were used for pain control, it was discussion were conducted by a multidisciplinary team. allowed to consume liquid after 3  h and solid food 6  h Patients were recommended to stop smoking and alcohol after. Infusion therapy was ended with the resumption of cessation for the entire perioperative period. The patient nutrition. The urethra was intraoperatively catheterized, was allowed to consume liquids and carbohydrate mix- the catheter was removed 6  h later. The next day after tures 2  h before surgery, bowels preparing was not per- the surgery, the patient underwent the final assessment, formed – the patient was prescribed a slag-free diet four control blood and urine tests, an ultrasound examina- days before surgery, and premedication of NSAIDs (keto- tion. In the case of a satisfactory condition, the patient profen) was performed. Antibacterial prophylaxis was was discharged. performed once, 30  min before the operation. The pro - tocol of multimodal anesthesia was applied according to Results the decision of the team of anesthesiologists. Of the 35 patients initially included in both comparison All operations were performed with the induction of groups, 13 were subsequently excluded from the study. an erection by injecting saline solution into the cavern- From the group of patients excluded from the study, 5 ous bodies. When performing the plication, the stand- dropped out due to deviations from the study protocol, ard Nesbitt procedure was used, with modifications in and 8 – for personal reasons. Deviations from the proto- several cases: without deglovation, medial variant. Thus, col were conventionally divided into primary, secondary, not all patients underwent penile scalping. Dissection and tertiary (Table 1). of the neurovascular bundle was performed laterally or The primary deviation from the protocol meant a medially. After the tunica albuginea was exposed, the forced change in the treatment protocol before the surgi- necessary volume of plication’s sutures was estimated to cal intervention. For two patients of the first group, we eliminate the curvature. Then stitches were performed on had to change the surgical tactics to plasty of the tunica the marked zones. albuginea with the use of graft due to the complex variant The rotation was carried out according to the Shaeer’s of curvature. corporate rotation III method, a reference to which was Secondary deviations occurred in a single case in the presented earlier. The operation involves the isolation first group and two cases in the second group, due to a of the dorsal neurovascular bundle and the execution of change in intraoperative tactics. For the patient of the first longitudinal colliding separate sutures throughout the group, due to the small bending angle (26 degrees) and his cavernous bodies, which unfold and fix the dorsal sur - wishes, intraoperatively we assessed the prospect of per- faces in the direction of each other. Rotary seams are forming TAP, which was performed. In the second group, applied until the desired result is achieved. a combined TAP correction in combination with buccal Intraoperatively, non-absorbable suture material Pro- graft transplantation was performed intraoperatively due line was used on cavernous bodies, monopolar coagu- to a significant bending angle and complex bending shape. lation was not used. The skin suture by the Monocryl There were no tertiary deviations from the study protocol. Table 1 Analysis of deviations from the research protocol Deviations Characteristic Group I Group II P CR TAP (n = 17) (n = 18) Primary deviations Different treatment method has been chosen, n (%) 2 (11.7%) 0 (0%) 0.157 No primary deviations from protocol, n 15 18 - Secondary deviations Intraoperative change of tactics, n (%) 1 (6.6%) 2 (11.1%) 0.685 No primary and secondary deviations from the protocol, n 14 16 - Tertiary deviations Changing the diagnosis, n (%) 0 (0%) 0 (0%) - Protocol feasibility, n (%) 14(82.3) 16(88.8) 0.878 To determine the value of P, a Chi-square comparison was used CR corporal rotation, TAP tunica albuginea plication Primary deviations - before the surgical intervention Secondary deviations - a change in intraoperative tactics Tertiary deviations – after the surgical intervention Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 6 of 11 The indicator of the likelihood of completing the treat - Table 2 Comparative characteristics of patients in comparison groups before surgery ment protocol, considering all three groups of deviations in this sample, was 82.3% and 88.8% for clinical groups Parameters Group I Group II Р I and II (p = 0.878), respectively. Due to such forced CR TAP (n = 9) (n = 13) deviations from the study protocol, these patients were excluded from the analysis according to the protocol General: (per-protocol) as not meeting the study criteria. Age, years 27.4 (±9.8) 28.2 (±10.27) 0.858 There were 5 (21.7%) patients of group I and 3 (13.0%) Height, cm 175.7 (±4.4) 174.4 (±8.5) 0.676 of group II who refused to participate in the study at any Weight, kg 71.7 (±8.4) 71.5 (±12.4) 0.960 stage. The completeness of clinical follow-up for patients Indicators of penile status: in both groups was 39.1% (9 cases) for group I and 56.5% Penile curvature angle, degrees 48.8 (±17.1) 48.2 (±14.9) 0.924 (13 cases) for group II. The analysis of the effectiveness of Length of an erect penis, cm 16.7 (±1.9) 16.1 (±2.2) 0.473 postoperative follow-up demonstrated its comparability The girth of the erect penis, cm 13.3 (±1.6) 12.8 (±1.48) 0.523 in both groups (by the Chi-squared test; p = 0.482). Vertical curvature, n (%) 7 (77.7%) 9 (69.2%) 0.218 u Th s, the final clinical analysis included 22 patients Congenital curvature, n (%) 7 (77.7%) 9 (69.2%) 0.218 (per-protocol) meeting all the study criteria. Of these, 2 Anamnesis: groups of patients were formed. The patients of the CR Smoking, n (%) 4 (44.4%) 8 (61.5%) 0.664 method (n = 9, group I) and the patients of the TAP pro- Alcohol abuse, n (%) 1 (11.1%) 1 (7.6%) 0.802 cedure (n = 13, group II). Allergy, n (%) 2 (22.2%) 3 (23%) 0.970 Table 2 presents comparative data on the initial param- IIEF5 before surgery, scores 21 (21;22) 20 (20;22) 0.300 eters of patients in the study groups. To determine the value of P, the Student’s criterion was used (in groups of The angle of penile curvature was from a minimum continuous data with a normal distribution of the trait; described as mean of 22 degrees to a maximum of 88 degrees, the length +/-SD;), chi-square criterion (in groups of nominal data; described as n (%)), nonparametric Mann-Whitney U-criterion (in groups of continuous data with a of the erect penis, respectively, 12.2–21.1  cm, and girth distribution of different from normal; denoted as median and 25–75 quartiles.) – 9.7–16.8 cm. IIEF5 International Index of Erectile Function All cases of horizontal penile curvature among the CR corporal rotation, TAP tunica albuginea plication enrolled patients were acquired. Analysis of the causes of the curvature (the study did not include patients with Pey- ronie’s disease) showed that in most cases they were idi- Data analysis showed that after CR there is a slight opathic or arose because of various medical interventions. shortening (on average 6 mm) and a decrease (on average u Th s, the analysis of the main characteristics of patients of 12  mm) in the girth of the erect penis (p < 0,05). CR in the comparison groups demonstrated their compara- can successfully eliminate curvature and improve copu- bility (p > 0.05). latory function (change in both parameters p < 0.001). The effectiveness of the treatment was assessed accord - TAP caused significant shortening (on average 24  mm, ing to several criteria: penile curvature no more than 10 p = 0.006) and a slight decrease (on average 3 mm) in the degrees, IIEF5 ≥ 21 points, satisfaction with the treat- girth of the erect penis. TAP can successfully eliminate ment according to the patient’s subjective perception, the curvature and improve copulatory function (change no subjective sensation of penile shortening, no subjec- in both parameters p < 0.001). tive sensation of changes in the thickness or shape of the Table  5 shows the comparative characteristics of the penis. Table 3 presents the treatment results divided into indicators of the postoperative state of patients in the two groups. comparison groups. All surgeries in both groups were successful according to the endpoints criteria. In the early and late postopera- Table 3 Evaluation of treatment outcomes using the composite tive periods, there were no cases of mortality in the two endpoints method groups. In the postoperative period, there were no com- Parameter Successful Satisfactory plications of anesthesia or deterioration of the general somatic status. The need for artificial ventilation or res - No curvature > 10 degrees + - piratory support did not arise in any case in the compari- IIEF5 ≥ 21 points + - son groups. Also, there were no cases of heart failure that Shortening of the penis, subjective + - required inotropic support. Table  4 presents the dynam- Changing the thickness or shape of the + - ics of changes in the parameters of the penile state and penis, subjective functional status before and after the surgery. Satisfaction with treatment + - IIEF5 International Index of Erectile Function V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 7 of 11 Table 4 Dynamics of the parameters of the state of the penis and functional status in the comparison groups before and after surgery Parameter. I group; CR (n = 9) Before 3 months after Difference Р Length of erect penis, cm 16.7 (± 1.9) 16.1 (± 1.8) -0.6 (± 0.07) 0.470 Girth of the erect penis, cm 13.3 (± 1.6) 12.1 (± 1.4) -1.2 (± 0.14) 0.119 The angle of the penile curva- 48.8 (± 17.1) 1 (1;1) -47.5 (± 15.9) < 0.001 ture, degrees IIEF-5, points 21 (21;22) 25 (25;25) +4 (3;4) < 0.001 Parameter. II group; TAP Initially Finally Difference Р (n = 13) Length of erect penis, cm 16.1 (± 2.2) 13.6 (± 1.8) -2.4 (± 0.8) 0.006 Girth of the erect penis, cm 12.8 (± 1.48) 12.4 (± 1.7) -0.3 (± 0.05) 0.585 The angle of the penile curva- 48.2 (± 14.9) 1 (1;1) -47.4 (± 14.7) < 0.001 ture, degrees IIEF-5, points 21 (20;22) 25 (25;25) +5 (3;5) < 0.001 To determine the value of P, the Student’s criterion was used (in groups of continuous data with a normal distribution of the trait; described as mean +/-SD;), chi- square criterion (in groups of nominal data; described as n (%)), nonparametric Mann-Whitney U-criterion (in groups of continuous data with a distribution of different from normal; denoted as median and 25–75 quartiles.) CR corporal rotation, TAP tunica albuginea plication IIEF5 International Index of Erectile Function The results analysis demonstrated that there were no The analysis of the comparative intergroup treatment significant complications in the postoperative period. efficacy based on the criteria established in the study The only complication in the early postoperative period showed good treatment results for 8 (88.8%) patients of was the occurrence of a small subcutaneous hematoma group I and 9 (69.2%) patients in group II (p = 0.577), in a patient of group I; evacuating the hematoma during according to Table 6. Satisfactory for everyone else. There bandaging and using tight bandaging of the penis for one were no negative outcomes. day solved the problem. Univariate and multivariate logistic regression analysis On average, all patients stayed for one day in the hos- made it possible to determine the predictors of compli- pital, which meets the protocol criteria for Fast-track cations (Table  6). The table shows the results with Chi- surgery. There were no changes in the hospital stay with squared test. either treatment. A simple (univariate) logistic regression analysis among Comparative analysis of objective and subjective 22 patients of both comparison groups, demonstrated parameters (length and girth of the erect penis) showed the significance in the prognosis of complaints of penile a significant difference in the comparison groups. Thus, shortening only by the preoperative curvature angle > 60 after CR, there is a relatively decrease in the girth of degrees in group II (OR 2.7; 95% CI 0.12; 5, 28; p = 0.040). the penis (p < 0.05), and after TAP, there is a significant Based on this ratio, the degree of influence of the predictor decrease in the length of the penis (p < 0.05). on the risk of shortening was calculated. Consequently, a Numbness of the glans penis was found in both com- previous penile curvature > 60 degrees increases the likeli- parison groups. This parameter in the short and long hood of complaints on penis shortening by 2.7. terms did not differ in the comparison groups (in both Obtained results helped to construct a model for pre- cases, p > 0.5). A palpable induration in the surgical area dicting the occurrence of complaints of penile shortening was detected only in the TAP group, with a no statistical in multivariate regression analysis (selection from predic- difference (p = 0.057). tor factors with a significance level of p < 0.1). There were Subjective assessment of the treatment results, as well as no significant predictors. the condition of the penis in the postoperative period, did Logistic regression analysis of the risk of changes in girth not differ in both groups (p > 0.05 for all three comparisons). or shape of the penis was similar. Penile length over 16 cm All patients were followed up for at least three months after surgery was a significant predictor (OR 0.77; 95% CI after surgery. For group I, the average observation period 0.07; 1.47; p = 0.029). For predictors of development of pal- was 682 days with a 95% CI of 217–617 days (maximum pable penile induration, the following factors were signifi - period of 1116 days). For group II, the average observa- cant: weight (OR 0.17; 95% CI 0.02; 0.33; p = 0.027), change tion period was 815 days with a 95% CI of 281–647 days in penile length (OR 2.1; 95% CI 0.32; 4.04; p = 0.021), short- (maximum period of 1276 days). ening > 2 cm (OR 2.7; 95% CI 0.28; 5.13; p = 0.029) and post- operative girth (OR 0.88; 95% CI 0.08; 1.68; p = 0.031). Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 8 of 11 Table 5 Comparison of sample parameters of treatment results Indicator Group I Group II Р CR TAP (n = 9) (n = 13) Average duration of hospitalization, days 1 (1;1) 1 (1;1) 1.0 Postoperative condition of the penis: Shortening of the penis > 1 cm, n (%) 0 (0%) 12 (92.3%) 0.009 Reducing penile girth > 1 cm, n (%) 8 (88.8%) 0 (0%) 0.003 Changing the length of the penis, cm -0.6 (±0.07) -2.4 (±0.8) <0.001 Changing of the girth of the penis, cm -1.2 (±0.14) -0.3 (±0.05) <0.001 Post-operative IIEF5, scores 25 (25;25) 25 (25;25) 0.946 Feeling numb, n (%) Up to 3 months after surgery 1 (11.1%) 3 (23.0%) 0.547 More than 3 months after surgery 1 (11.1%) 2 (15.3%) 0.801 Infectious complications, n (%) 0 (0) 0 (0) 0 Surgical seam insolvency, n (%) 0 (0) 0 (0) 0 Postoperative hematoma, n (%) 1 (11.1%) 0 (0%) 0.243 Palpable induration, n (%) 0(0%) 6 (46.1%) 0.057 Subjective patient satisfaction, n (%) 9 (100%) 11(84.6%) 0.789 Subjective shortening of the penis, n (%) 0 (0%) 4 (30.7%) 0.113 Subjective reduction of girth or change of penile shape, n (%) 1 (11.1%) 0 (0%) 0.243 To determine the value of P, the Student’s criterion was used (in groups of continuous data with a normal distribution of the trait; described as mean +/-SD;), chi- square criterion (in groups of nominal data; described as n (%)), nonparametric Mann-Whitney U-criterion (in groups of continuous data with a distribution of different from normal; denoted as median and 25–75 quartiles.) IIEF5 - International Index of Erectile Function CR corporal rotation, TAP tunica albuginea plication Multivariate analysis did not show reliable results as a reverse deformity/curvature of the penis in the post- (p > 0,05 for all tests). operative period, caused by spontaneous rupture of the It should be noted that both methods of treatment have thread or untied knot [16, 28]. During the study period, zero operating and hospital mortality and a low incidence there were no cases of reverse deformity, a single devel- of postoperative complications. Both methods of treatment opment of postoperative hematoma did not require reop- are highly effective and safe for penile curvature correction. eration and was eliminated conservatively. The probability of numbness of the glans penis was comparable in both comparison groups. Numbness resolved on its own over Discussion time, which also correlates with the data of other authors The average normal size of an erect penis is a length of [8]. Plication revealed several cases of subjective com- 13.1 (± 1.66) cm and a circumference of 11.6 (± 1.10) plaints of the presence of seals, which, nevertheless, did cm [27]. Currently, the criterion for the effectiveness not differ significantly for the comparison groups [29, 30]. of surgical treatment is a relatively straight penis (bend However, the authors believe that this conclusion is not less than 20 degrees, which does not prevent the copula- accurate and is due to the small sample size. tory act). A shortening of the penis of less than 1.5 cm is When comparing the results, a statistically significant also a favorable outcome [5, 15]. In the presented study, difference in the parameters of the penis was noted. achieved results indicate the effective and safe use of However, these changes did not affect the subjective per - both methods for correcting penile curvature. ception of the results of treatment. In general, the data Typical complications of any of the curvature correc- are consistent with the results of the Shaeer CR surgery tion methods are the postoperative hematomas (6.5%), [22] and various TAP modifications [11–13]. painful or unpleasant indurations in the plication or rota- Logistic regression analysis revealed interesting and tion areas (1.4–73%), changes in the sensitivity of the debatable results. There is no doubt about the reliability glans penis (0–37%), shortening of the penis (up to 80%), of the risk of significant shortening of the penis after pli - wound infection (1.4%) and some more rare complica- cation in patients with a bend of more than 60 degrees. tions [15, 16]. There can be a technical complication such V orobev et al. Basic and Clinical Andrology (2023) 33:10 Page 9 of 11 Table 6 Predictors of complications Factor Sign Univariate analysis Multivariate analysis χ OR (95% CI) Р OR (95% CI) Р Subjective shortening of the erect penis. Height 6.65 0.28(-0.002;0.57) 0.052 0.6(-256;22.07) 0.099 Multifactor logit-regression: Weight 13.99 0.49(-0.09;1.0) 0.101 - ‑ χ = 13.63; р = 0.0035 Penile curvature before 3.7 0.07 (-0.009:0.15) 0.083 -0.04(-0.25;0.1) 0.709 Angle before surge ry > 60 5.06 2.7(0.12;5.28) 0.040 6.8(-1.75;15.4) 0.119 Length before > 15.5 cm 2.56 0.42(-0.11;0.96) 0.126 - - Changing the length > 2 cm 16.72 8.9(-11.2;29.1) 0.384 - - Girth before surgery 2.61 0.52(-0.14;1.19) 0.123 - - IIEF5 before surgery 1.19 -0.40(-1.13;0.33) 0.283 - - Allergy 2.82 -1.4(-3.2;0.3) 0.113 - - Subjective reduction of girth or shape of the Curvature angle after surgery 1.38 0.47(-0.38;1.33) 0.278 - - erect penis. Length after surgery > 16 cm 8.08 0.77(0.07;1.47) 0.029 - - Change in length > 1cm 20.59 -8.4 (-18.1:1.15) 0.085 - - Girth before surgery 1.04 0.27(-0.26;0.80) 0.318 - - Palpable induration Height 5.93 0.22(-0.009;0.45) 0.060 - - Weight 8.23 0.17(0.02;0.33) 0.027 - - Horizontal curvature 2.02 0.03 (-0.02:0.09) 0.158 - - Penile curvature before 1.06 -0.05(-0.1;0.001) 0.310 - - Angle before surgery > 60 2.02 1.46(-0.56;3.5) 0.158 - - Length before surgery 3.56 0.45(-0.05;0.96) 0.082 - - Changing length 12.19 2.1(0.32;4.04) 0.021 - - Shortening > 2 cm 6.37 2.7(0.28;5.13) 0.029 - - Girth before surgery 3.65 0.57(-0.06;1.2) 0.079 - - Girth after surgery 6.73 0.88(0.08;1.68) 0.031 - - This conclusion is consistent with the works of other the works presented in more detail, the authors con- authors [5, 15]. We consider the influence of the length of cluded about a different method for calculating the the penis more than 16 cm on the risk of changes in the length of an erect penis, which provides a significant dif - girth or shape of the penis after surgery, and the effect of ference in TAP results. Thus, most authors before the weight on the risk of developing palpable indurations as surgery measure the length of the penis using a straight doubtful since there is only an indirect logical connec- metal ruler, which gives unreliable results for the curve of tion. The influence of plication on the absolute value of the midline of the penis [32]. In addition, the authors do the girth of the penis after surgery are natural. However, not describe the endpoints of measurement (glans to the there is a need for further studies with a larger sample. skin of the pubis, or glans to the symphysis), which has Several researchers [14, 16] do not report the linear the potential to influence (with different measurement dimensions of the penile shortening, relying on the sub- techniques in different patients or the same patient at dif - jective perception of patients in the postoperative period, ferent stages of the study) the results within the frame- which is a less reliable presentation of treatment results work of even one study [33]. It means that there is a need in comparison with a complex subjective and objective for a more detailed presentation in scientific works of the assessment. Meanwhile, the results with accurate linear applied measurement methods, as well as the use of more data in some cases indicate the absence of a significant reliable measurement with a flexible tape, measuring change in length after TAP procedures [31]. Such works thread, or in another similar way. raise questions, reporting a slight objective decrease in The partial mobilization of the urethra to release the the postoperative length of the penis. On the contrary, ventral parts of the corpora cavernosa can presumably some studies indicate a more significant decrease in be the solution to the problem of reducing the girth of length after TAP from 0 to 2.5-5  cm, depending on the the penis after rotational operations. Thus, it can help initial curvature angle and the type of curvature (appar- to solve the problem of deformation of the corpus cav- ently, the ventral version provides a more significant ernosum during its rotation, but this problem requires a shortening) with TAP procedures [5, 15, 32]. Analyzing separate study. In this case, the efficiency of straightening Vorobev et al. Basic and Clinical Andrology (2023) 33:10 Page 10 of 11 IIEF5 International Index of Erectile Function directly depends on the length of the rotation. That is, ISMU Irkutsk State Medical University for this surgery, the more significant the curvature, the TAP tunica albuginea plication greater the mobilization of the neurovascular bundle and Acknowledgements the implementation of many retaining sutures. Not applicable. Separately, the authors would like to note that a high subjective assessment of the results of treatment, even Authors’ contributions All authors contributed to the study conception and design. Material prepara- with the shortening of the penis, is probably due to a sig- tion, data collection and analysis were performed by Vladimir Vorobev, Andrey nificant improvement in copulatory function, leveling Sherbatykh, Olga Baklanova, and Stepan Sidorov. The first draft of the manu- other negative sensations. However, copulatory function script was written by Vladimir Beloborodov, Sergei Popov and Alexey Kalyagin. All authors read and approved the final manuscript. was not evaluated in the study. u Th s, the results and their comparison with the data Funding presented earlier in scientific publications were analyzed. The authors received no financial support for the research, authorship, and/or publication of this article. Comparative analysis is difficult due to the small number of works on the problem of penile curvature without Pey- Availability of data and materials ronie’s disease, as well as on the search for predictors of Data will be available on request. a specific type of complications after performing TAP or CR. There is a need for further study in larger samples Declarations and a comparison of the obtained data with the results Ethics approval and consent to participate of other authors. A significant advantage of the work is The research was conducted ethically in accordance with the World Medical an isolated analysis (no relapse, one team of surgeons, Association Declaration of Helsinki. The research was approved by the local ethics committees of Irkutsk State Medical University. refusal to re-enroll in the study, etc.) analysis of the Informed consent was signed by participants. influence of various factors on the likelihood of postop - erative complications. Limitations of the research: rela- Consent for publication Not applicable. tively small samples, the average postoperative follow-up period of less than five years, single-center study. Competing interests The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Conclusion Both methods are safe, effective, and bring minimal Author details risks of complications. Both surgical techniques lead to Department of General Surgery, Irkutsk State Medical University, Irkutsk, Russian Federation. Department of Theoretical Surgery, Irkutsk State Medical a change in the geometry of the erect penis: they allow University, Irkutsk, Russian Federation. Department of Introduction to Internal to eliminate the curvature but are accompanied by short- 4 Medicine, Irkutsk State Medical University, Irkutsk, Russian Federation. Depar t- ening (Plication is more pronounced than Rotation) or ment of Urology, GBUZ State Oncology Hospital, Irkutsk, Russian Federation. Department of Urology, Irkutsk State Medical University, Irkutsk, Russian a decrease in grith (Rotation is more pronounced than Federation. Plication). Patients should be warned about the conse- quences, and the method of surgical technique should be Received: 4 January 2023 Accepted: 11 January 2023 discussed with the presentation of possible outcomes. Based on the results, important criteria for the selec- tion of patients are formulated: Plication techniques are References not recommended for patients with pronounced curva- 1. Yachia D, Beyar M, Aridogan IA, Dascalu S. The incidence of congenital ture, or initial dissatisfaction with the size of the penis; penile curvature. J Urol. 1993;150(5):1478–9. https:// doi. org/ 10. 1016/ Rotation techniques require the greater mobilization of S0022- 5347(17) 35816-0. 2. Montag S, Palmer LS. 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Modern research in the field of microen- thorough peer review by experienced researchers in your field capsulation (review). Drug Dev Registr. 2021;10(2):50–61. https:// doi. org/ 10. 33380/ 2305- 2066- 2021- 10-2- 50- 61. rapid publication on acceptance 25. Flisyuk EV, Belokurov SS, Narkevich IA, Flisyuk OM, Ivkin DYu. The support for research data, including large and complex data types analysis of process of crushing in the vibrocavitational homog- • gold Open Access which fosters wider collaboration and increased citations enizer. Drug Dev Registr. 2020;9(4):53–8. https:// doi. org/ 10. 33380/ 2305- 2066- 2020-9- 4- 53- 58. maximum visibility for your research: over 100M website views per year 26. Hara H, van Klaveren D, Kogame N, Chichareon P, Modolo R, Tomaniak M, Ono M, Kawashima H, Takahashi K, Capodanno D, Onuma Y, Serruys PW. At BMC, research is always in progress. Statistical methods for composite endpoints. 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Journal

Basic and Clinical Andrology – Springer Journals

Published: Mar 30, 2023

Keywords: Penile curvature; Congenital curvature of the penis; Corporoplasty; Rotational corporoplasty; Plication of the tunica albuginea of the corpora cavernosa; Corporal rotation; Courbure pénienne; Courbure congénitale du Pénis; Corporoplastie; Corporoplastie rotationnelle; Plicature de la Tunique albuginée des Corps caverneux; Rotation corporelle

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