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Adjustable Perineal Male Sling for the Treatment of Urinary Incontinence: Long-term Results
Accepted Manuscript Title: Adjustable Perineal Male Sling for the Treatment of Urinary Incontinence;Long Term Results Author: Mesut Altan, Tariq Asi, Cenk Yucel Bilen, Ali Ergen PII: DOI: Reference:
S0090-4295(17)30402-8 http://dx.doi.org/doi: 10.1016/j.urology.2017.04.030 URL 20418
To appear in:
Urology
Received date: Accepted date:
15-2-2017 20-4-2017
Please cite this article as: Mesut Altan, Tariq Asi, Cenk Yucel Bilen, Ali Ergen, Adjustable Perineal Male Sling for the Treatment of Urinary Incontinence;Long Term Results, Urology (2017), http://dx.doi.org/doi: 10.1016/j.urology.2017.04.030. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
TITLE PAGE Adjustable Perineal Male Sling for the treatment of Urinary Incontinence;Long Term Results 1. Mesut ALTAN, M.D. * Urology resident Hacettepe University School of Medicine, Department of Urology Mobile: +90 555 865 8193 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE 2. Tariq Asi, M.D.** Urology resident Hacettepe University School of Medicine, Department of Urology Mobile: +90 507 776 2861 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE 3. Cenk Yucel Bilen, Prof.Dr. Professor of Urology Hacettepe University School of Medicine, Department of Urology Mobile: +90 5335568442 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE 4. Ali Ergen, Prof. Dr. Professor of Urology Hacettepe University School of Medicine, Department of Urology Mobile: +90 532 286 6530 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE • * First author • ** Corresponding author
Abstract Objective To present the long-term results in patients with urinary incontinence who were treated with adjustable perineal male sling. Materials and Methods An adjustable male sling procedure was performed in 45 patients with a mean age of 67.6±7.8 years who had urinary incontinence. The mean period between primary prostatic surgery and the sling procedure was 36.7 months. The difference between the classical sling and the adjustable one is a 10 cm tissue expander between the two layers of polypropylene mesh with an injection port. Adjustment of the sling was performed with saline via this port, in case of recurrence or persistence of incontinence. Results Mean follow-up was 48±29 months. Average operative time was 101.1±25.5 min (45-150). Median daily pad use in these patients decreased from 8(2-12) to 1(010)(p<0.001). During long-term follow-up 37.8% used zero pads daily, 28.9% used 1 to 2 pads daily, making the total success rate 66.7%. Complete dry rate was higher in patients with non-severe incontinence compared to the others with severe incontinence (57.9% 23.1%, p=0.029). Nevertheless; there was no 1 Page 1 of 18
significant difference in the case of total success rate (%78.9 vs 57.7%, respectively; p=0.135). Age was significantly greater in both complete dry group (71.1±4.8 vs 65.4±8.7) and total success group (70.1±5.2 vs 62.4±5.2) (p=0.017, p<0.001, respectively). Conclusion Adjustable male sling is an acceptable procedure with low complication rates especially in patients with mild and moderate incontinence. At the same time, this procedure may be offered to patients with previous incontinence surgery Keywords: urinary incontinence; adjustable sling; long-term results; postprostatectomy incontinence
Introduction Urinary adverse events after radical prostatectomy, particularly urinary incontinence, are bothersome and can lead to significant decrease in quality of life. In addition to having knowledge of the risk factors for development of persistent urinary incontinence, it is important to understand the standard treatment options. The natural history of recovery is extremely important in determining when intervention is needed. The rate of urinary incontinence after RP depends on the definition of urinary incontinence and the methodology used to collect the data. Questionnaire based studies indicate that 25% to 69% of patients experience incontinence after surgery (1, 2). The management of such expected and debilitating complication should start preoperatively- by determining the risk factors and educating the patientsand intraoperatively by using surgical techniques lowering both the severity and the time interval required to continence. In the early postoperative period -3 to 6 months- especially in patients with mild-to-moderate urinary incontinence, a trial
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of conservative management including Pelvic Floor Muscle Exercises (Kegel) should be tried (3). Patients who fail to improve with conservative management and who are having severe urinary incontinence should be offered surgical intervention. The artificial urinary sphincter (AUS) is still the gold standard for incontinence after prostatectomy (4). Despite its effectiveness the artificial sphincter is an expensive mechanical device that requires manual opening to empty the bladder, the revision rate is somewhat 30% and the risk of infection or erosion requiring prosthesis removal is 4.5% to 23% at 10 years (5). Sling procedures for incontinence are conceptually attractive, in that they are inexpensive and not mechanical, and they allow physiological voiding without significant obstruction (6-8). However, the traditional bone anchoring sling operation does not allow adjustment of the tension of the sling material postoperatively and it could result in progressive failure with time (9). This study aims to present the long-term results of the adjustable male sling procedure. In this technique tension over the fatty tissue and the urethra is adjusted by injecting saline into a tissue expander using a self-sealing valve postoperatively .We present our initial experience and results with this device for creating an adjustable male sling.
Methods and Materials Between May 2005 and august 2013, 58 consecutive patients with urinary incontinence underwent an implantation of a perineal sling with a tissue 3 Page 3 of 18
expander. The results of 45 patients who achieved complete data were evaluated. The underlying etiology of urinary incontinence was radical prostatectomy in 22 patients (21 retropubic radical prostatectomy and 1 laparoscopic radical prostatectomy), transurethral prostate resection in 14, open prostatectomy in 8 and radical cystectomy with an orthotropic ileal neo-bladder in 1. A history was obtained, including the degree of incontinence as reflected by daily pad use, prior pelvic radiotherapy, previous extensive urethral surgery and age. All patients underwent cystoscopy to exclude anastomotic stenosis. In addition to the previously reported 19 patients, 4 patients with previous incontinence surgery were evaluated with urodynamic study (cytometry or pressure flow). A standard urodynamic study was performed to evaluate bladder storage and voiding capabilities. Urodynamic study was not performed routine if there were not any over active bladder symptoms, previously incontinence surgery or pelvic radiotherapy. According to the number of pads used for 24 hours, incontinence was grouped as mild (1-2 pads), moderate (3-5 pads) and severe (more than 5 pads) (7). Patients were classified into two groups: severe and non-severe incontinent. All patients received prophylactic antibiotics (Sulbactam /ampicillin) before the induction of anesthesia. The operation was done as described before by Inci et al (10).
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Patients were followed every 2 weeks for month 1 and every 3 months thereafter with a history, daily pad use, physical examination and post-void residual urine measurement. Results are presented as the mean ± standard deviation (parametric) and the median (nonparametric) with the IQR. Differences between groups were analyzed using the Mann-Whitney U test for unpaired data and the Wilcoxon signed rank test for paired data with p<0.05 considered significant. All statistical data were processed using SPSS®.
Results: Mean follow-up of the male sling operation with the tissue expander was 48 ± 29 months and mean patient age at operation was 67.6±7.8. Before the operation all patients used pads to manage incontinence with a median pad consumption of 8 (2-12) per day. 60 % of patients had severe incontinence. 13 (28.9%) of patients had undergone previous surgery for incontinence, including a perineal male sling in 7, bladder neck injection in 3, rectus fascia sling following an unsuccessful bladder neck injection in 1 and a male sling with polypropylene mesh tape in 2. Demographic variables were given in Table 1. The mean period between primary prostatic surgery and the sling procedure was 36.7 months. The mean maximum flow rate before surgery was 15.7±3.6 ml per second and mean detrusor pressure at maximum flow was 36.5±8.2 cm H2O. Mean leak pressure point (LPP) was 23.5±6.1 cm H2O. These variables were obtained through urodynamic studies. 5 Page 5 of 18
During long-term follow-up 37.8 % used zero pads daily, 28.9 % used 1 to 2 pads daily, making the total success rate 66.7%. Median daily pad use in these patients decreased from 8 (2-12) to 1 (0-10) (p<0.001). Complete dry rate was higher in patients with non-severe incontinence compared to the others with severe incontinence (57.9% 23.1%, p =0.029). Nevertheless; there was no significant difference in the case of total success rate (%78.9 vs 57.7%, respectively; p=0.135). This is likely due to small numbers preventing a significant difference from being found, while the difference may well exist. Age was significantly greater in both complete dry group (71.1±4.8 vs 65.4±8.7) and total success group (70.1±5.2 vs 62.4±5.2) (p=0.017, p<0.001, respectively). Neither complete dry rate nor total success rate was related to the primary operation (p=0.150, p=0.299) or previous incontinence surgery (p=0.920, p=0.460) (Table 2). Success rates of primary surgery were given in Table 3. Long-term results (mean follow up: 51.2±36 month) of the previously reported 19 patients- in whom the underlying etiology of urinary incontinence was radical prostatectomy in 10 patients, transurethral prostate resection in 4, open prostatectomy in 4 and radical cystectomy with an orthotopic ileal neobladder in 1- were analyzed separately and 31.5% (6/19) were completely dry, 36.8% (7/19) were improved making the total success rate to be 68.3%. Before surgery all 19 patients used pads to manage incontinence with an average pad consumption of 10.3 _ 2.5 per day. From these 19 patients seven patients had undergone previous surgery for incontinence, including a perineal male sling in 4, bladder neck injection in 1, rectus fascia sling following an unsuccessful bladder neck
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injection in 1 and a male sling with polypropylene mesh tape in 1. Four patients had diabetes mellitus and 2 had a history of pelvic radiotherapy. Average operative time was 101.1±25.5 min (45-150). There was no Intraoperative complication. One patient with a superficial wound infection was treated successfully with antibiotic therapy only. One patient required surgical revision due to infection 9 months postoperatively. Four patients underwent repeat catheterization because of early urinary retention and they were able to void 7 days after catheterization. No complications related to mesh erosion, de novo voiding dysfunction or mechanical failure occurred. Ten patients reported mild to moderate perineal pain in the early postoperative period but it resolved in all patients with painkiller. None of the patients had voiding difficulty or significant post-void residual urine volume during follow-up. Eight patients were completely dry without any injection. The total number of injections was 68, the median number of adjustments was 2 (0-10). The adjustments were done via the injection port using an insulin needle until full continence was achieved. Injection was started with 3 cc and increased by 1 cc at each injection. We asked patients to return to confirm continence status 2 days following each adjustment. Additional injections were done in cases of recurrent incontinence (10). It’s a fact that Fibrosis will increase due to balloon swelling and will negatively affect continence outcomes. However, if there is incontinence in previously successful patients, we will inflate the balloon without time constraints.
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The procedure failed in 15 patients. Of them 4 patients requested expander extraction without any new operation preference. AUS was placed in 2 patients. Another adjustable male sling operation was done to 4 patients, 2 of them had improving results. No intervention was done to the other 5 patients.
Discussion
Stress urinary incontinence after radical prostatectomy is an important and a bothersome complication. Even in the most experienced hands, incontinence rate after retropubic radical prostatectomy (RRP) is 7% (11). Compared to RRP similar incontinence rates are reported from robot-assisted RP as its getting widely used in the treatment of prostate cancer (12). Considering the increase in continence rates especially during the first postoperative period, pelvic floor muscle training and behavioral modifications are important conservative treatment modalities. In the case of persistent urinary incontinence AUS is considered an accepted and important treatment modality (13). Despite the wide range published in the literature the complete dry and the total success rates were 43.5% (4.3-85.7) and 79% (60.9-100), respectively (14). A pooled analysis showed that infection or erosion occurred in 8.5% of cases (3.3-27.8%), mechanical failure in 6.2% of cases (2.0-13.8%), and urethral atrophy in 7.9% (1.9-28.6%). Reoperation rate was 26.0% (14.8-44.8%) (14). Another important 8 Page 8 of 18
issue is the placement of a mechanical device in patients' bodies. Patients who strongly wish to avoid a mechanical device are willing to go against an artificial urinary sphincter (15). İt’s considered an expensive procedure with a cost of 5000$ in our country (17). That’s why it has been inevitable to investigate less invasive procedures. Although male sling has become widely used in recent years in postprostatectomy incontinence (PPI) treatment, it still has not found its own place with limited number of studies and incomplete long term outcomes. Due to the different techniques being reported and different evaluations for continence, it is still controversial to consider it as a systematic treatment. Throughout the years there were three major types of sling operations. Bone-anchoring (BAS), retrourethral trans-obturator (RTS), adjustable retro-pubic (ARS). Success rates were reported as 40-88%, 76-91% and 72-79% respectively (16). At the same time, complete dry rates are lower at 16-75%, 9-74% and 40-66%, respectively (16). When analysing these results the absence of long-term follow-up periods should be considered. Adjustable male sling was first reported from our center in 2007 (10). Being cheap is one of the notable features of this method. It’s cost is about 500$ (17). Of the patients 15 (78.9%) were completely dry and 2 (10.5%) improved significantly to 1 to 2 pads per day at a mean follow-up of 17.3 months (range 12 to 25). Balci et al applied the same technique to 21 patients with severe incontinence (17). Mean follow-up time was 40.1±23.2 (6-74) months. 16 patients (76.2%) were completely dry (11 patients, 0 pads; 5 patients using safety pads). 9 Page 9 of 18
With mean follow-up of 45.6 ±32.5 months 37.8 % of patients used zero pads daily and 28.9 % used 1 to 2 pads daily, making the total success rate 66.7%. Another important problem in the male sling procedure is the declining success rates over time. In Castle et al study of 38 patients underwent BAS despite reporting 47.6% complete dry rate after 6 months follow-up this rate decreased to 25.8% after 18 months (9). Onur et al reported the 18-month outcomes of 48 BAS patients (18). Median time for failure was reported as 3 (18) months (15). The fact that the traditional BAS process does not have an adjustable sling material is a major disadvantage. It can be argued that this condition is associated with decreasing continence rates in postoperative followup. In this study, it’s noteworthy that complete dry rate decreased from 78.9% to 37.8% with the increase in both patient number and follow-up period. Similarly, total success rate decreased from 89.4% to 66.7% with increased follow-up period. In the first reported 19 patients total success and complete dry rates dropped from 89.4%, 78.9% to 68.3% and 36.8% respectively. We think it’s related to the pressure caused by the balloon which leads to the necrosis of the tissue covering the urethra. Although this silicone balloon tries to compensate, the displacement of the silicon material is considered another possible cause. Balci and his colleagues used a 25 mL volume balloon and claimed that this balloon size could improve success. They have not reported any serious complications (17). Especially in patients with radiotherapy (RT) history, decreased success after PPI surgery has been reported (19-21). However, Hubner et al in their study
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of 101 patients underwent Argus sling reported that 20 patients from the 22 patients with radiotherapy history still dry in their last control (22). In our study, two patients with previous pelvic RT were seen as unsuccessful. No radiationrelated statistics were made for only two radiation cases. There was no effect of patients’ age, ethology (RRP or non-RRP) and previous incontinence surgery on success rate. Factors associated with success in male SUI treatment are not clearly established (23). For BAS surgery it was set that worse preoperative incontinence grade is associated with increasing failure rates (24, 25). Cornu et al in their series of 136 RTS
patients reported that surgery failure was
associated with > 200 g ped weight/day (26). In our series, in non-severe incontinence cases complete dry and success rate were found as 57.9% and 78.9%, respectively. Although it was not statistically significant, the success rate in patients with severe incontinence was lower than that of non-severe. (57.7% vs 78.9%). Decreased success rate in patients with severe incontinence should be taken into account and shared with the patient. Interestingly, the average age of patients with complete dry and success was significantly higher. The reason for this is thought to be the age-related decrease in pelvic muscle support which could be strengthened with the settled sling. However, the relatively low number of patients may have affected these outcomes. The most important limitation of this study is that it is retrospective and it contains a small number of patients. Another important limitation is that only the number of pads was used in the preoperative or postoperative follow-up of patients, quality of life or symptom score was not used. Because the number of
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patients with mild incontinence was two, the relationship between success and incontinence grade was not clearly assessed and only patients with severe incontinence were compared with the other two groups. Another limitation is the lack of routine preoperative urodynamic studies in patients. In addition to the previously reported 19 patients it was done in cases with previous incontinence surgery and overactive bladder symptoms. Results showed that all patients didn’t have any neurogenic or bladder related problems leading to incontinence. Leak pressure point (LPP) has been recognized as a tool for determining the severity of stress incontinence, the effectiveness of therapy, and the presence of intrinsic sphincter deficiency (ISD), which is clinically important, especially before determining the surgical correction of SUI. The wide variabilities of LPP measurement by different test environments should be considered when determining urethral function in SUI patients (27). In our study, As 60% of patients had severe incontinance LPP was expected to be low. Conclusion Adjustable male sling is an acceptable procedure with low complication rates especially in patients with mild and moderate incontinence. At the same time, this procedure can also be offered to patients with previous incontinence surgery.
References
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1. Bates TS, Wright MP, Gillatt DA. Prevalence and impact of incontinence and impotence following total prostatectomy assessed anonymously by the ICS-male questionnaire. Eur Urol. 1998;33(2):165-9. 2. Talcott JA, Rieker P, Propert KJ, Clark JA, Wishnow KI, Loughlin KR, et al. Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy. J Natl Cancer Inst. 1997;89(15):1117-23. 3. Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet. 2000;355(9198):98102. 4. Biardeau X, Aharony S, Campeau L, Corcos J. Overview of the 2015 ICS Consensus Conference. Neurourol Urodyn. 2016;35(4):437-43. 5. Venn SN, Greenwell TJ, Mundy AR. The long-term outcome of artificial urinary sphincters. J Urol. 2000;164(3 Pt 1):702-6; discussion 6-7. 6. Comiter CV. The male perineal sling: intermediate-term results. Neurourol Urodyn. 2005;24(7):648-53. 7. Rajpurkar AD, Onur R, Singla A. Patient satisfaction and clinical efficacy of the new perineal bone-anchored male sling. Eur Urol. 2005;47(2):237-42; discussion 42.
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8. Madjar S, Jacoby K, Giberti C, Wald M, Halachmi S, Issaq E, et al. Bone anchored sling for the treatment of post-prostatectomy incontinence. J Urol. 2001;165(1):72-6. 9. Castle EP, Andrews PE, Itano N, Novicki DE, Swanson SK, Ferrigni RG. The male sling for post-prostatectomy incontinence: mean followup of 18 months. J Urol. 2005;173(5):1657-60. 10. Inci K, Ergen A, Bilen CY, Yuksel S, Ozen H. A new device for the treatment of post-prostatectomy incontinence: adjustable perineal male sling. J Urol. 2008;179(2):605-9. 11. Kundu SD, Roehl KA, Eggener SE, Antenor JA, Han M, Catalona WJ. Potency, continence and complications in 3,477 consecutive radical retropubic prostatectomies. J Urol. 2004;172(6 Pt 1):2227-31. 12. Yaxley JW, Coughlin GD, Chambers SK, Occhipinti S, Samaratunga H, Zajdlewicz L, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet. 2016. 13. Herschorn S, Bruschini H, Comiter C, Grise P, Hanus T, Kirschner-Hermanns R, et al. Surgical treatment of stress incontinence in men. Neurourol Urodyn. 2010;29(1):179-90. 14. Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Eur Urol. 2013;63(4):681-9. 14 Page 14 of 18
15. Kumar A, Litt ER, Ballert KN, Nitti VW. Artificial urinary sphincter versus male sling for post-prostatectomy incontinence--what do patients choose? J Urol. 2009;181(3):1231-5. 16. Welk BK, Herschorn S. The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2012;109(3):328-44. 17. Balci M, Tuncel A, Bilgin O, Aslan Y, Atan A. Adjustable perineal male sling using tissue expander as an effective treatment of post-prostatectomy urinary incontinence. Int Braz J Urol. 2015;41(2):312-8. 18. Onur R, Rajpurkar A, Singla A. New perineal bone-anchored male sling: lessons learned. Urology. 2004;64(1):58-61. 19. Giberti C, Gallo F, Schenone M, Cortese P, Ninotta G. The bone anchor suburethral synthetic sling for iatrogenic male incontinence: critical evaluation at a mean 3-year followup. J Urol. 2009;181(5):2204-8. 20. Bochove-Overgaauw DM, Schrier BP. An adjustable sling for the treatment of all degrees of male stress urinary incontinence: retrospective evaluation of efficacy and complications after a minimal followup of 14 months. J Urol. 2011;185(4):1363-8. 21. Bauer RM, Soljanik I, Fullhase C, Karl A, Becker A, Stief CG, et al. Mid-term results for the retroluminar transobturator sling suspension for stress urinary incontinence after prostatectomy. BJU Int. 2011;108(1):94-8.
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22. Hubner WA, Gallistl H, Rutkowski M, Huber ER. Adjustable bulbourethral male sling: experience after 101 cases of moderate-to-severe male stress urinary incontinence. BJU Int. 2011;107(5):777-82. 23. Giberti C, Gallo F, Schenone M, Cortese P. The bone-anchor sub-urethral sling for the treatment of iatrogenic male incontinence: subjective and objective assessment after 41 months of mean follow-up. World J Urol. 2008;26(2):173-8. 24. Fassi-Fehri H, Badet L, Cherass A, Murat FJ, Colombel M, Martin X, et al. Efficacy of the InVance male sling in men with stress urinary incontinence. Eur Urol. 2007;51(2):498-503. 25. Guimaraes M, Oliveira R, Pinto R, Soares A, Maia E, Botelho F, et al. Intermediate-term results, up to 4 years, of a bone-anchored male perineal sling for treating male stress urinary incontinence after prostate surgery. BJU Int. 2009;103(4):500-4. 26. Cornu JN, Sebe P, Ciofu C, Peyrat L, Cussenot O, Haab F. Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: focus on prognostic factors. BJU Int. 2011;108(2):236-40. 27. Seo YH, Kim SO, Yu HS, Kwon D. Leak point pressure at different bladder volumes in stress urinary incontinence in women: Comparison between Valsalva and cough-induced leak point pressure. Can Urol Assoc J. 2016;10(1-2):E23-7.
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Table 1. Demographic features Age, mean±SD Ped number, median (range) Primary sugery, n(%) RRP TUR-P Cystectomy + ileal loop SPTV-P Severe incontinence Abscent n(%) Present Urethral stricture history Abscent n(%) Present Previous continance Abscent surgery Perineal male sling Bladder neck injection Rectus fascia sling Male sling with polypropylene mesh tape Radiotherapy history Present Abscent
67.6±7.8 8 (2-12) per day 22 (48.9%) 14 (31.1%) 1 (2.2%) 8 (17.8) 18 (40%) 27 (60%) 22 (48.9%) 23 (51.1%) 32 (71.1%) 7 (15.5%) 3 (6.6%) 1 (2.2%) 2 (4.4%) 2 (4.4%) 43 (95.6%)
Table 2. Factors affecting Complete dry and total success. Success Parameters Complete dry (dry +improvement) Yes No p Yes No P Age, year, mean±SD
71.1±4. 8 RP 27.3 Other 47.8 Yes 37.5 No 38.5
65.4±8. 7 72.7 52.2 62.5 61.5
0.017*
70.1±5 .2 0.155┴ 59.1 73.9 65.6 0.952┴ 69.2
62.4±5. 2 40.9 26.1 34.4 30.8
Etiology, n(%) Previous incontinenc e surgery, n(%) Severe Yes 57.9 42.1 0.017┴ 78.9 21.1 incontinenc e, n(%) No 23.1 76.9 57.7 42.3 *Mann whiney U test, ┴chi-square test; RP, Radical Prostatectomy.
<0.001 * 0.292┴
0.816┴ 0.135┴
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Table 3.Success rates of primary surgery Primary surgery
Complete dry
Success (dry +improvement) %59.1 (13/22) %78.6(11/14) %87.5 (7/8) %100 (1/1)
RP %27.3 (6/22) TUR-P %35.7 (5/14) SPTV-P %62.5 (5/8) Cystectomy+ileal %100 (1/1) loop TUR-P,Transurethral Resection Of Prostate; SPTV-P, Suprapubic Transvesical Prostatectomy
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S0090-4295(17)30402-8 http://dx.doi.org/doi: 10.1016/j.urology.2017.04.030 URL 20418
To appear in:
Urology
Received date: Accepted date:
15-2-2017 20-4-2017
Please cite this article as: Mesut Altan, Tariq Asi, Cenk Yucel Bilen, Ali Ergen, Adjustable Perineal Male Sling for the Treatment of Urinary Incontinence;Long Term Results, Urology (2017), http://dx.doi.org/doi: 10.1016/j.urology.2017.04.030. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
TITLE PAGE Adjustable Perineal Male Sling for the treatment of Urinary Incontinence;Long Term Results 1. Mesut ALTAN, M.D. * Urology resident Hacettepe University School of Medicine, Department of Urology Mobile: +90 555 865 8193 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE 2. Tariq Asi, M.D.** Urology resident Hacettepe University School of Medicine, Department of Urology Mobile: +90 507 776 2861 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE 3. Cenk Yucel Bilen, Prof.Dr. Professor of Urology Hacettepe University School of Medicine, Department of Urology Mobile: +90 5335568442 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE 4. Ali Ergen, Prof. Dr. Professor of Urology Hacettepe University School of Medicine, Department of Urology Mobile: +90 532 286 6530 e-mail: [email protected] Adress: Hacettepe Üniversitesi Hastaneleri, Erişkin Hastanesi, B Katı Üroloji Anabilim Dalı, 06100 Sıhhıye ANKARA/TÜRKİYE • * First author • ** Corresponding author
Abstract Objective To present the long-term results in patients with urinary incontinence who were treated with adjustable perineal male sling. Materials and Methods An adjustable male sling procedure was performed in 45 patients with a mean age of 67.6±7.8 years who had urinary incontinence. The mean period between primary prostatic surgery and the sling procedure was 36.7 months. The difference between the classical sling and the adjustable one is a 10 cm tissue expander between the two layers of polypropylene mesh with an injection port. Adjustment of the sling was performed with saline via this port, in case of recurrence or persistence of incontinence. Results Mean follow-up was 48±29 months. Average operative time was 101.1±25.5 min (45-150). Median daily pad use in these patients decreased from 8(2-12) to 1(010)(p<0.001). During long-term follow-up 37.8% used zero pads daily, 28.9% used 1 to 2 pads daily, making the total success rate 66.7%. Complete dry rate was higher in patients with non-severe incontinence compared to the others with severe incontinence (57.9% 23.1%, p=0.029). Nevertheless; there was no 1 Page 1 of 18
significant difference in the case of total success rate (%78.9 vs 57.7%, respectively; p=0.135). Age was significantly greater in both complete dry group (71.1±4.8 vs 65.4±8.7) and total success group (70.1±5.2 vs 62.4±5.2) (p=0.017, p<0.001, respectively). Conclusion Adjustable male sling is an acceptable procedure with low complication rates especially in patients with mild and moderate incontinence. At the same time, this procedure may be offered to patients with previous incontinence surgery Keywords: urinary incontinence; adjustable sling; long-term results; postprostatectomy incontinence
Introduction Urinary adverse events after radical prostatectomy, particularly urinary incontinence, are bothersome and can lead to significant decrease in quality of life. In addition to having knowledge of the risk factors for development of persistent urinary incontinence, it is important to understand the standard treatment options. The natural history of recovery is extremely important in determining when intervention is needed. The rate of urinary incontinence after RP depends on the definition of urinary incontinence and the methodology used to collect the data. Questionnaire based studies indicate that 25% to 69% of patients experience incontinence after surgery (1, 2). The management of such expected and debilitating complication should start preoperatively- by determining the risk factors and educating the patientsand intraoperatively by using surgical techniques lowering both the severity and the time interval required to continence. In the early postoperative period -3 to 6 months- especially in patients with mild-to-moderate urinary incontinence, a trial
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of conservative management including Pelvic Floor Muscle Exercises (Kegel) should be tried (3). Patients who fail to improve with conservative management and who are having severe urinary incontinence should be offered surgical intervention. The artificial urinary sphincter (AUS) is still the gold standard for incontinence after prostatectomy (4). Despite its effectiveness the artificial sphincter is an expensive mechanical device that requires manual opening to empty the bladder, the revision rate is somewhat 30% and the risk of infection or erosion requiring prosthesis removal is 4.5% to 23% at 10 years (5). Sling procedures for incontinence are conceptually attractive, in that they are inexpensive and not mechanical, and they allow physiological voiding without significant obstruction (6-8). However, the traditional bone anchoring sling operation does not allow adjustment of the tension of the sling material postoperatively and it could result in progressive failure with time (9). This study aims to present the long-term results of the adjustable male sling procedure. In this technique tension over the fatty tissue and the urethra is adjusted by injecting saline into a tissue expander using a self-sealing valve postoperatively .We present our initial experience and results with this device for creating an adjustable male sling.
Methods and Materials Between May 2005 and august 2013, 58 consecutive patients with urinary incontinence underwent an implantation of a perineal sling with a tissue 3 Page 3 of 18
expander. The results of 45 patients who achieved complete data were evaluated. The underlying etiology of urinary incontinence was radical prostatectomy in 22 patients (21 retropubic radical prostatectomy and 1 laparoscopic radical prostatectomy), transurethral prostate resection in 14, open prostatectomy in 8 and radical cystectomy with an orthotropic ileal neo-bladder in 1. A history was obtained, including the degree of incontinence as reflected by daily pad use, prior pelvic radiotherapy, previous extensive urethral surgery and age. All patients underwent cystoscopy to exclude anastomotic stenosis. In addition to the previously reported 19 patients, 4 patients with previous incontinence surgery were evaluated with urodynamic study (cytometry or pressure flow). A standard urodynamic study was performed to evaluate bladder storage and voiding capabilities. Urodynamic study was not performed routine if there were not any over active bladder symptoms, previously incontinence surgery or pelvic radiotherapy. According to the number of pads used for 24 hours, incontinence was grouped as mild (1-2 pads), moderate (3-5 pads) and severe (more than 5 pads) (7). Patients were classified into two groups: severe and non-severe incontinent. All patients received prophylactic antibiotics (Sulbactam /ampicillin) before the induction of anesthesia. The operation was done as described before by Inci et al (10).
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Patients were followed every 2 weeks for month 1 and every 3 months thereafter with a history, daily pad use, physical examination and post-void residual urine measurement. Results are presented as the mean ± standard deviation (parametric) and the median (nonparametric) with the IQR. Differences between groups were analyzed using the Mann-Whitney U test for unpaired data and the Wilcoxon signed rank test for paired data with p<0.05 considered significant. All statistical data were processed using SPSS®.
Results: Mean follow-up of the male sling operation with the tissue expander was 48 ± 29 months and mean patient age at operation was 67.6±7.8. Before the operation all patients used pads to manage incontinence with a median pad consumption of 8 (2-12) per day. 60 % of patients had severe incontinence. 13 (28.9%) of patients had undergone previous surgery for incontinence, including a perineal male sling in 7, bladder neck injection in 3, rectus fascia sling following an unsuccessful bladder neck injection in 1 and a male sling with polypropylene mesh tape in 2. Demographic variables were given in Table 1. The mean period between primary prostatic surgery and the sling procedure was 36.7 months. The mean maximum flow rate before surgery was 15.7±3.6 ml per second and mean detrusor pressure at maximum flow was 36.5±8.2 cm H2O. Mean leak pressure point (LPP) was 23.5±6.1 cm H2O. These variables were obtained through urodynamic studies. 5 Page 5 of 18
During long-term follow-up 37.8 % used zero pads daily, 28.9 % used 1 to 2 pads daily, making the total success rate 66.7%. Median daily pad use in these patients decreased from 8 (2-12) to 1 (0-10) (p<0.001). Complete dry rate was higher in patients with non-severe incontinence compared to the others with severe incontinence (57.9% 23.1%, p =0.029). Nevertheless; there was no significant difference in the case of total success rate (%78.9 vs 57.7%, respectively; p=0.135). This is likely due to small numbers preventing a significant difference from being found, while the difference may well exist. Age was significantly greater in both complete dry group (71.1±4.8 vs 65.4±8.7) and total success group (70.1±5.2 vs 62.4±5.2) (p=0.017, p<0.001, respectively). Neither complete dry rate nor total success rate was related to the primary operation (p=0.150, p=0.299) or previous incontinence surgery (p=0.920, p=0.460) (Table 2). Success rates of primary surgery were given in Table 3. Long-term results (mean follow up: 51.2±36 month) of the previously reported 19 patients- in whom the underlying etiology of urinary incontinence was radical prostatectomy in 10 patients, transurethral prostate resection in 4, open prostatectomy in 4 and radical cystectomy with an orthotopic ileal neobladder in 1- were analyzed separately and 31.5% (6/19) were completely dry, 36.8% (7/19) were improved making the total success rate to be 68.3%. Before surgery all 19 patients used pads to manage incontinence with an average pad consumption of 10.3 _ 2.5 per day. From these 19 patients seven patients had undergone previous surgery for incontinence, including a perineal male sling in 4, bladder neck injection in 1, rectus fascia sling following an unsuccessful bladder neck
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injection in 1 and a male sling with polypropylene mesh tape in 1. Four patients had diabetes mellitus and 2 had a history of pelvic radiotherapy. Average operative time was 101.1±25.5 min (45-150). There was no Intraoperative complication. One patient with a superficial wound infection was treated successfully with antibiotic therapy only. One patient required surgical revision due to infection 9 months postoperatively. Four patients underwent repeat catheterization because of early urinary retention and they were able to void 7 days after catheterization. No complications related to mesh erosion, de novo voiding dysfunction or mechanical failure occurred. Ten patients reported mild to moderate perineal pain in the early postoperative period but it resolved in all patients with painkiller. None of the patients had voiding difficulty or significant post-void residual urine volume during follow-up. Eight patients were completely dry without any injection. The total number of injections was 68, the median number of adjustments was 2 (0-10). The adjustments were done via the injection port using an insulin needle until full continence was achieved. Injection was started with 3 cc and increased by 1 cc at each injection. We asked patients to return to confirm continence status 2 days following each adjustment. Additional injections were done in cases of recurrent incontinence (10). It’s a fact that Fibrosis will increase due to balloon swelling and will negatively affect continence outcomes. However, if there is incontinence in previously successful patients, we will inflate the balloon without time constraints.
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The procedure failed in 15 patients. Of them 4 patients requested expander extraction without any new operation preference. AUS was placed in 2 patients. Another adjustable male sling operation was done to 4 patients, 2 of them had improving results. No intervention was done to the other 5 patients.
Discussion
Stress urinary incontinence after radical prostatectomy is an important and a bothersome complication. Even in the most experienced hands, incontinence rate after retropubic radical prostatectomy (RRP) is 7% (11). Compared to RRP similar incontinence rates are reported from robot-assisted RP as its getting widely used in the treatment of prostate cancer (12). Considering the increase in continence rates especially during the first postoperative period, pelvic floor muscle training and behavioral modifications are important conservative treatment modalities. In the case of persistent urinary incontinence AUS is considered an accepted and important treatment modality (13). Despite the wide range published in the literature the complete dry and the total success rates were 43.5% (4.3-85.7) and 79% (60.9-100), respectively (14). A pooled analysis showed that infection or erosion occurred in 8.5% of cases (3.3-27.8%), mechanical failure in 6.2% of cases (2.0-13.8%), and urethral atrophy in 7.9% (1.9-28.6%). Reoperation rate was 26.0% (14.8-44.8%) (14). Another important 8 Page 8 of 18
issue is the placement of a mechanical device in patients' bodies. Patients who strongly wish to avoid a mechanical device are willing to go against an artificial urinary sphincter (15). İt’s considered an expensive procedure with a cost of 5000$ in our country (17). That’s why it has been inevitable to investigate less invasive procedures. Although male sling has become widely used in recent years in postprostatectomy incontinence (PPI) treatment, it still has not found its own place with limited number of studies and incomplete long term outcomes. Due to the different techniques being reported and different evaluations for continence, it is still controversial to consider it as a systematic treatment. Throughout the years there were three major types of sling operations. Bone-anchoring (BAS), retrourethral trans-obturator (RTS), adjustable retro-pubic (ARS). Success rates were reported as 40-88%, 76-91% and 72-79% respectively (16). At the same time, complete dry rates are lower at 16-75%, 9-74% and 40-66%, respectively (16). When analysing these results the absence of long-term follow-up periods should be considered. Adjustable male sling was first reported from our center in 2007 (10). Being cheap is one of the notable features of this method. It’s cost is about 500$ (17). Of the patients 15 (78.9%) were completely dry and 2 (10.5%) improved significantly to 1 to 2 pads per day at a mean follow-up of 17.3 months (range 12 to 25). Balci et al applied the same technique to 21 patients with severe incontinence (17). Mean follow-up time was 40.1±23.2 (6-74) months. 16 patients (76.2%) were completely dry (11 patients, 0 pads; 5 patients using safety pads). 9 Page 9 of 18
With mean follow-up of 45.6 ±32.5 months 37.8 % of patients used zero pads daily and 28.9 % used 1 to 2 pads daily, making the total success rate 66.7%. Another important problem in the male sling procedure is the declining success rates over time. In Castle et al study of 38 patients underwent BAS despite reporting 47.6% complete dry rate after 6 months follow-up this rate decreased to 25.8% after 18 months (9). Onur et al reported the 18-month outcomes of 48 BAS patients (18). Median time for failure was reported as 3 (18) months (15). The fact that the traditional BAS process does not have an adjustable sling material is a major disadvantage. It can be argued that this condition is associated with decreasing continence rates in postoperative followup. In this study, it’s noteworthy that complete dry rate decreased from 78.9% to 37.8% with the increase in both patient number and follow-up period. Similarly, total success rate decreased from 89.4% to 66.7% with increased follow-up period. In the first reported 19 patients total success and complete dry rates dropped from 89.4%, 78.9% to 68.3% and 36.8% respectively. We think it’s related to the pressure caused by the balloon which leads to the necrosis of the tissue covering the urethra. Although this silicone balloon tries to compensate, the displacement of the silicon material is considered another possible cause. Balci and his colleagues used a 25 mL volume balloon and claimed that this balloon size could improve success. They have not reported any serious complications (17). Especially in patients with radiotherapy (RT) history, decreased success after PPI surgery has been reported (19-21). However, Hubner et al in their study
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of 101 patients underwent Argus sling reported that 20 patients from the 22 patients with radiotherapy history still dry in their last control (22). In our study, two patients with previous pelvic RT were seen as unsuccessful. No radiationrelated statistics were made for only two radiation cases. There was no effect of patients’ age, ethology (RRP or non-RRP) and previous incontinence surgery on success rate. Factors associated with success in male SUI treatment are not clearly established (23). For BAS surgery it was set that worse preoperative incontinence grade is associated with increasing failure rates (24, 25). Cornu et al in their series of 136 RTS
patients reported that surgery failure was
associated with > 200 g ped weight/day (26). In our series, in non-severe incontinence cases complete dry and success rate were found as 57.9% and 78.9%, respectively. Although it was not statistically significant, the success rate in patients with severe incontinence was lower than that of non-severe. (57.7% vs 78.9%). Decreased success rate in patients with severe incontinence should be taken into account and shared with the patient. Interestingly, the average age of patients with complete dry and success was significantly higher. The reason for this is thought to be the age-related decrease in pelvic muscle support which could be strengthened with the settled sling. However, the relatively low number of patients may have affected these outcomes. The most important limitation of this study is that it is retrospective and it contains a small number of patients. Another important limitation is that only the number of pads was used in the preoperative or postoperative follow-up of patients, quality of life or symptom score was not used. Because the number of
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patients with mild incontinence was two, the relationship between success and incontinence grade was not clearly assessed and only patients with severe incontinence were compared with the other two groups. Another limitation is the lack of routine preoperative urodynamic studies in patients. In addition to the previously reported 19 patients it was done in cases with previous incontinence surgery and overactive bladder symptoms. Results showed that all patients didn’t have any neurogenic or bladder related problems leading to incontinence. Leak pressure point (LPP) has been recognized as a tool for determining the severity of stress incontinence, the effectiveness of therapy, and the presence of intrinsic sphincter deficiency (ISD), which is clinically important, especially before determining the surgical correction of SUI. The wide variabilities of LPP measurement by different test environments should be considered when determining urethral function in SUI patients (27). In our study, As 60% of patients had severe incontinance LPP was expected to be low. Conclusion Adjustable male sling is an acceptable procedure with low complication rates especially in patients with mild and moderate incontinence. At the same time, this procedure can also be offered to patients with previous incontinence surgery.
References
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1. Bates TS, Wright MP, Gillatt DA. Prevalence and impact of incontinence and impotence following total prostatectomy assessed anonymously by the ICS-male questionnaire. Eur Urol. 1998;33(2):165-9. 2. Talcott JA, Rieker P, Propert KJ, Clark JA, Wishnow KI, Loughlin KR, et al. Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy. J Natl Cancer Inst. 1997;89(15):1117-23. 3. Van Kampen M, De Weerdt W, Van Poppel H, De Ridder D, Feys H, Baert L. Effect of pelvic-floor re-education on duration and degree of incontinence after radical prostatectomy: a randomised controlled trial. Lancet. 2000;355(9198):98102. 4. Biardeau X, Aharony S, Campeau L, Corcos J. Overview of the 2015 ICS Consensus Conference. Neurourol Urodyn. 2016;35(4):437-43. 5. Venn SN, Greenwell TJ, Mundy AR. The long-term outcome of artificial urinary sphincters. J Urol. 2000;164(3 Pt 1):702-6; discussion 6-7. 6. Comiter CV. The male perineal sling: intermediate-term results. Neurourol Urodyn. 2005;24(7):648-53. 7. Rajpurkar AD, Onur R, Singla A. Patient satisfaction and clinical efficacy of the new perineal bone-anchored male sling. Eur Urol. 2005;47(2):237-42; discussion 42.
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8. Madjar S, Jacoby K, Giberti C, Wald M, Halachmi S, Issaq E, et al. Bone anchored sling for the treatment of post-prostatectomy incontinence. J Urol. 2001;165(1):72-6. 9. Castle EP, Andrews PE, Itano N, Novicki DE, Swanson SK, Ferrigni RG. The male sling for post-prostatectomy incontinence: mean followup of 18 months. J Urol. 2005;173(5):1657-60. 10. Inci K, Ergen A, Bilen CY, Yuksel S, Ozen H. A new device for the treatment of post-prostatectomy incontinence: adjustable perineal male sling. J Urol. 2008;179(2):605-9. 11. Kundu SD, Roehl KA, Eggener SE, Antenor JA, Han M, Catalona WJ. Potency, continence and complications in 3,477 consecutive radical retropubic prostatectomies. J Urol. 2004;172(6 Pt 1):2227-31. 12. Yaxley JW, Coughlin GD, Chambers SK, Occhipinti S, Samaratunga H, Zajdlewicz L, et al. Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study. Lancet. 2016. 13. Herschorn S, Bruschini H, Comiter C, Grise P, Hanus T, Kirschner-Hermanns R, et al. Surgical treatment of stress incontinence in men. Neurourol Urodyn. 2010;29(1):179-90. 14. Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN. The artificial urinary sphincter after a quarter of a century: a critical systematic review of its use in male non-neurogenic incontinence. Eur Urol. 2013;63(4):681-9. 14 Page 14 of 18
15. Kumar A, Litt ER, Ballert KN, Nitti VW. Artificial urinary sphincter versus male sling for post-prostatectomy incontinence--what do patients choose? J Urol. 2009;181(3):1231-5. 16. Welk BK, Herschorn S. The male sling for post-prostatectomy urinary incontinence: a review of contemporary sling designs and outcomes. BJU Int. 2012;109(3):328-44. 17. Balci M, Tuncel A, Bilgin O, Aslan Y, Atan A. Adjustable perineal male sling using tissue expander as an effective treatment of post-prostatectomy urinary incontinence. Int Braz J Urol. 2015;41(2):312-8. 18. Onur R, Rajpurkar A, Singla A. New perineal bone-anchored male sling: lessons learned. Urology. 2004;64(1):58-61. 19. Giberti C, Gallo F, Schenone M, Cortese P, Ninotta G. The bone anchor suburethral synthetic sling for iatrogenic male incontinence: critical evaluation at a mean 3-year followup. J Urol. 2009;181(5):2204-8. 20. Bochove-Overgaauw DM, Schrier BP. An adjustable sling for the treatment of all degrees of male stress urinary incontinence: retrospective evaluation of efficacy and complications after a minimal followup of 14 months. J Urol. 2011;185(4):1363-8. 21. Bauer RM, Soljanik I, Fullhase C, Karl A, Becker A, Stief CG, et al. Mid-term results for the retroluminar transobturator sling suspension for stress urinary incontinence after prostatectomy. BJU Int. 2011;108(1):94-8.
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22. Hubner WA, Gallistl H, Rutkowski M, Huber ER. Adjustable bulbourethral male sling: experience after 101 cases of moderate-to-severe male stress urinary incontinence. BJU Int. 2011;107(5):777-82. 23. Giberti C, Gallo F, Schenone M, Cortese P. The bone-anchor sub-urethral sling for the treatment of iatrogenic male incontinence: subjective and objective assessment after 41 months of mean follow-up. World J Urol. 2008;26(2):173-8. 24. Fassi-Fehri H, Badet L, Cherass A, Murat FJ, Colombel M, Martin X, et al. Efficacy of the InVance male sling in men with stress urinary incontinence. Eur Urol. 2007;51(2):498-503. 25. Guimaraes M, Oliveira R, Pinto R, Soares A, Maia E, Botelho F, et al. Intermediate-term results, up to 4 years, of a bone-anchored male perineal sling for treating male stress urinary incontinence after prostate surgery. BJU Int. 2009;103(4):500-4. 26. Cornu JN, Sebe P, Ciofu C, Peyrat L, Cussenot O, Haab F. Mid-term evaluation of the transobturator male sling for post-prostatectomy incontinence: focus on prognostic factors. BJU Int. 2011;108(2):236-40. 27. Seo YH, Kim SO, Yu HS, Kwon D. Leak point pressure at different bladder volumes in stress urinary incontinence in women: Comparison between Valsalva and cough-induced leak point pressure. Can Urol Assoc J. 2016;10(1-2):E23-7.
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Table 1. Demographic features Age, mean±SD Ped number, median (range) Primary sugery, n(%) RRP TUR-P Cystectomy + ileal loop SPTV-P Severe incontinence Abscent n(%) Present Urethral stricture history Abscent n(%) Present Previous continance Abscent surgery Perineal male sling Bladder neck injection Rectus fascia sling Male sling with polypropylene mesh tape Radiotherapy history Present Abscent
67.6±7.8 8 (2-12) per day 22 (48.9%) 14 (31.1%) 1 (2.2%) 8 (17.8) 18 (40%) 27 (60%) 22 (48.9%) 23 (51.1%) 32 (71.1%) 7 (15.5%) 3 (6.6%) 1 (2.2%) 2 (4.4%) 2 (4.4%) 43 (95.6%)
Table 2. Factors affecting Complete dry and total success. Success Parameters Complete dry (dry +improvement) Yes No p Yes No P Age, year, mean±SD
71.1±4. 8 RP 27.3 Other 47.8 Yes 37.5 No 38.5
65.4±8. 7 72.7 52.2 62.5 61.5
0.017*
70.1±5 .2 0.155┴ 59.1 73.9 65.6 0.952┴ 69.2
62.4±5. 2 40.9 26.1 34.4 30.8
Etiology, n(%) Previous incontinenc e surgery, n(%) Severe Yes 57.9 42.1 0.017┴ 78.9 21.1 incontinenc e, n(%) No 23.1 76.9 57.7 42.3 *Mann whiney U test, ┴chi-square test; RP, Radical Prostatectomy.
<0.001 * 0.292┴
0.816┴ 0.135┴
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Table 3.Success rates of primary surgery Primary surgery
Complete dry
Success (dry +improvement) %59.1 (13/22) %78.6(11/14) %87.5 (7/8) %100 (1/1)
RP %27.3 (6/22) TUR-P %35.7 (5/14) SPTV-P %62.5 (5/8) Cystectomy+ileal %100 (1/1) loop TUR-P,Transurethral Resection Of Prostate; SPTV-P, Suprapubic Transvesical Prostatectomy
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