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Adjustable sling for the treatment of post-prostatectomy urinary incontinence: systematic review and meta-analysis

ABSTRACT

Urinary incontinence after prostatectomy has a significant negative impact on the quality of life of the patient. The surgical treatment includes several models of male slings, such as adjustable slings. The objective of this study was to evaluate the effectiveness and safety of adjustable sling in the treatment of post-prostatectomy urinary incontinence. This is a systematic review of literature. The following electronic databases were searched until January 2018: PubMed®, Embase, CENTRAL and LILACS. The keywords used in the search strategies were: “prostatectomy” [Mesh], “urinary incontinence” [Mesh] and “suburethral slings” [Mesh]. Randomized clinical trials and observational studies, with or without Control Group, and follow-up of more than 12 months were included. Only one randomized study with high risk of bias was included and it concluded the effectiveness equivalence between adjustable and non-adjustable slings. All other studies were cases series with patients of varying levels of incontinence intensity and history of pelvic radiation therapy and previous surgeries. The meta-analysis for 0 pad in 24 hours demonstrated an effectiveness of 53%. For the 0 to 1 pad test in 24 hours, the meta-analysis resulted in an effectiveness of 69%. Risk factors for surgery failure include prior radiation, severity of post-prostatectomy urinary incontinence, and previous surgeries. The meta-analysis of the extrusion rate was 9.8% and the most commonly reported adverse effects were pain and local infection. Evidence of low quality indicates that adjustable slings are effective for treating post-prostatectomy urinary incontinence, with frequency of adverse events similar to the surgical option considered gold standard (the artificial urinary sphincter implant).

Suburethral slings; Urinary incontinence; Prostatectomy

RESUMO

A incontinência urinária pós-prostatectomia tem importante impacto negativo na qualidade de vida do portador. O tratamento cirúrgico inclui slings masculinos e, entre os diversos modelos, os slings ajustáveis. O objetivo deste estudo foi avaliar a efetividade e a segurança do sling ajustável no tratamento da incontinência urinária pós-prostatectomia. Trata-se de revisão sistemática de literatura. Foram pesquisadas as seguintes bases de dados eletrônicas até janeiro de 2018: PubMed®, Embase, CENTRAL e LILACS. As palavras-chaves utilizadas nas estratégias de busca foram: “prostatectomy” [Mesh], “urinary incontinence” [Mesh] e “suburethral slings” [Mesh]. Foram incluídos ensaios clínicos randomizados e estudos observacionais controlados ou não com seguimento maior que 12 meses. Apenas um estudo randomizado com alto risco de viés foi localizado e concluiu a equivalência de efetividade de slings ajustáveis e não ajustáveis. Todos os outros estudos foram série de casos com pacientes de variados níveis de intensidade da incontinência e histórico de radioterapia pélvica e cirurgias prévias. A metanálise para 0 pad em 24 horas demonstrou efetividade de 53%. Para o desfecho 0 a 1 pad em 24 horas, a metanálise resultou em efetividade de 69%. Os fatores de risco para insucesso da cirurgia incluem radiação prévia, gravidade da incontinência urinária pós-prostatectomia e cirurgias anteriores. A metanálise da taxa de extrusão foi de 9,8%, e os efeitos adversos mais relatados foram dor e infecção local. Evidências de baixa qualidade indicam que os slings ajustáveis são efetivos para o tratamento da incontinência urinária pós-prostatectomia, com frequência de eventos adversos semelhantes à opção cirúrgica considerada padrão-ouro (o implante de esfíncter urinário artificial).

Slings suburetrais; Incontinência urinária; Prostatectomia

INTRODUCTION

Urinary incontinence is a well-known sequela of prostate surgeries due to benign or malignant diseases, and it is a frequently undesired outcome, with a significant negative impact on the quality of life of patients.11. Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008;358(12):1250-61. Most patients presenting post-prostatectomy urinary incontinence (PPI) suffer from intrinsic sphincter deficiency, isolated or associated with detrusor dysfunction,22. Ullrich NF, Comiter CV. The male sling for stress urinary incontinence: Urodynamic and subjective assessment. J Urol. 2004;172(1):204-6. and present stress urinary incontinence, i.e., complaint of involuntary loss of urine upon exertion.33. van der Horst C, Naumann CM, Al-Najaar A, Seif C, Stübinger SH, Jünemann KP, Braun PM. [Etiology and pathophysiology of male stress incontinence]. Urologe A. 2007;46(3):233-9. Review. German.

The urinary incontinence rates after surgery of a benign prostate disease are similar in various types of surgical treatment, but tend to be slightly higher after open prostatectomy (0 to 8.4%).44. Abrams P, Andersson KE, Birder L, Brubaker L, Cardozo L, Chapple C, Cottenden A, Davila W, de Ridder D, Dmochowski R, Drake M, Dubeau C, Fry C, Hanno P, Smith JH, Herschorn S, Hosker G, Kelleher C, Koelbl H, Khoury S, Madoff R, Milsom I, Moore K, Newman D, Nitti V, Norton C, Nygaard I, Payne C, Smith A, Staskin D, Tekgul S, Thuroff J, Tubaro A, Vodusek D, Wein A, Wyndaele JJ; Members of Committees; Fourth International Consultation on Incontinence. Fourth International Consultation on Incontinence Recommendations of the International Scientific Committee: Evaluation and treatment of urinary incontinence, pelvic organ prolapse, and fecal incontinence. Neurourol Urodyn. 2010;29(1):213-40. Review. The incidence of urinary incontinence after radical prostatectomy is controversial, since the rates of several studies ranged from 0.8 to 87%.55. Augustin H, Pummer K, Daghofer F, Habermann H, Primus G, Hubmer G. Patient self-reporting questionnaire on urological morbidity and bother after radical retropubic prostatectomy. Eur Urol. 2002;42(2):112-7.

6. Burkhard FC, Kessler TM, Fleischmann A, ThalmannGN, Schumacher M, Studer UE. Nerve-sparing open radical retropubic prostatectomy? Does it have an impact on urinary continence? J Urol. 2006;176(1):189-95.

7. Haab F, Yamaguchi R, Leach GE. Postprostatectomy incontinence. Urol Clin North America. 1996;23(3):447-57. Review.

8. Penson DF, McLerran D, Feng Z, Li L, Albertsen PC, Gilliland FC, et al. 5-year urinary and sexual outcomes after radical prostatectomy: results from the prostate cancer outcomes study. J Urol. 2005;173(5):1701-5.

9. Sacco E, Prayer-Galetti T, Pinto F, Fracalanza S, Betto G, Pagano F, et al. Urinary incontinence after radical prostatectomy: incidence by definition, risk factors and temporal trend in a large series with a long-term follow-up. BJU Int. 2006;97(6):1234-41.

10. Veenema RJ, GurselEO, LattimerJK. Radical retropubic prostatectomy for cancer: a 20-year experience. J Urol. 1977;117(3):330-1.
-1111. Walsh PC, Marschke P, Ricker D, Burnett AL. Patient reported urinary continence and sexual function after anatomic radical prostatectomy. Urology. 2000; 55(1):58-61. This wide variation is probably due to lack of standardized definition of urinary incontinence, progression time after surgery, diagnostic methods, and characteristics of the population studied.

The surgical treatment of PPI should be indicated only 6 to 12 months after prostate surgery. During this period, some conservative therapies, such as pelvic floor muscle training, interventions in lifestyle, and biofeedback must be considered.1212. Bauer RM, Bastian PJ, Gozzi C, Stief CG. Postprostatectomy Incontinence: all about diagnosis and management. Eur Urol. 2009;55(2):322-33. Review. The surgical treatment options include injection of substances that cause volume increase and occlude parts of the urethra, male slings, placement of inflatable balloons that partially occlude the urethra, and artificial urinary sphincter implantation.

The artificial urinary sphincter demonstrated favorable long-term results, and so far has been considered the gold standard for PPI. Nonetheless, this option has well-established surgical complication rates, including urethral erosion (6%), infections (5%), mechanical failures (6%), and need for revision (21% within 5 years, and 50% within 10 years.1313. Comiter CV, Dobberfuhl AD. The artificial urinary sphincter and male sling for postprostatectomy incontinence: which patient should get which procedure? Investig Clin Urol. 2016;57(1):3-13. Review. Therefore, the use of male slings has recently increased, for providing a simpler and less invasive intervention, not requiring mechanical device manipulation by patients.

Several male sling models have been launched in the last decade and, despite the different mechanisms of action, the primary objective is compression of the urethral bulb with adequate tension, maintaining tension to prevent leaks, and balance between detrusor tension and contractility to avoid urinary retention.1313. Comiter CV, Dobberfuhl AD. The artificial urinary sphincter and male sling for postprostatectomy incontinence: which patient should get which procedure? Investig Clin Urol. 2016;57(1):3-13. Review. The current male sling models available can be divided as transobturator suburethral, and the more recent adjustable retropubic.

The adjustable retropubic slings are generally inserted in a suburethral position, under the bulbospongiosus muscle, making pressure mainly on the bulbar urethra and, at a lesser extent, on the membranous urethra. In the postoperative follow-up, if there is not enough tension to achieve continence, it can be readjusted by a minimally invasive procedure, specific for each model.1414. Kretschmer A, Hübner W, Sandhu JS, Bauer RM. Evaluation and management of postprostatectomy incontinence: a systematic review of current literature. Eur Urol Focus. 2016;2(3):245-59. Review. The adjustable slings available comprise Argus® (Promedon, Cordoba, Argentina), ArgusT® (Promedon, Cordoba, Argentina), ReMeex® (Neomedic, Barcelona, Spain) and ATOMS® (AMI, Feldkirch, Austria).

A vast literature on these slings has been recently published, and according to the reports, they are effective, even in cases of sever PPI grave, and in previously irradiated patients. However, no specific systematic review has been published for these models so far.

OBJECTIVE

To evaluate the effectiveness and safety of adjustable male slings in treatment of post-prostatectomy urinary incontinence.

METHODS

This systematic review and meta-analysis were conducted in accordance with the PRISMA1515. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. Ann Intern Med. 2009;151(4):W65-94. protocol, and registered at the International Prospective Register of Systematic Reviews (PROSPERO), with identification code CRD42017082431.

Types of study

This project included controlled or non-controlled randomized clinical trials and observational studies that evaluated surgical implantation of adjustable sling for treatment of PPI. Only studies with more than 12 months of follow-up were selected.

Type of participants

Studies with adults presenting with PPI for more than 6 months, with no improvement from conservative treatment, were eligible.

Type of intervention

Included studies were those that evaluated the surgical implantation of the adjustable sling, compared or not to any other type of surgery for PPI treatment.

Types of outcome measurements

The primary outcome was cure evaluated by the standardized 24-hour pad test.1616. Nitti VW, Mourtzinos A, Brucker BM; SUFU Pad Test Study Group. Correlation of patient perception of pad use with objective degree of incontinence measured by pad test in men with post-prostatectomy incontinence: the SUFU Pad Test Study. J Urol. 2014;192(3):836-42. Secondary outcomes included adverse events and the need for adjustments in follow-up.

Research for the identification of studies

Investigations were made in databanks up until January 2018: PubMed®, EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), and Latin American and Caribbean Health Sciences Literature (LILACS) (Tables 1 to 4 ). A search was made of ongoing studies at Site ClinicalTrials (https://clinicaltrials.gov/). There was no restriction as to language or date of publication. The reference lists of relevant studies were verified for possible locations of studies.

Table 1
Search terms used in all databases

Table 2
Search strategy at MEDLINE via PubMed®

Table 3
Search strategy at Latin American and Caribbean Health Sciences Literature (LILACS) via Latin-American and Caribbean Center for Health Sciences Information (BIREME)

Table 4
Search strategy at EMBASE via Ovid®

Study selection

Two authors independently evaluated the studies identified by the literature search as to eligibility. In the case of any uncertainty as to the eligibility of studies based on the title and abstract, the complete text was obtained and examined by the two reviewers. In case of disagreement, a third author was consulted until a consensus was reached. All studies considered eligible were fully obtained and analyzed.

Methodological evaluation of the studies included

Two authors assessed the included studies in an independent manner as to methodology quality. To evaluate the quality of the methodology in randomized clinical trials, the Cochrane1717. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [Internet]. [updated March 2011]. The Cochrane Collaboration; 2011 [cited 2019 Apr 7]. Available from: www.cochrane-handbook.org
www.cochrane-handbook.org...
Collaboration tool was used, and for observational studies, the instrument for critical evaluation of the Chan et al., case series type was utilized.1818. Chan K, Bhandari M. Three-minute critical appraisal of a case series article. Indian J Orthop. 2011;45(2):103-4.

Synthesis and data analysis

Measurements of absolute and relative frequencies were calculated with confidence intervals of 95% (95%CI). For the results of continuous variables, central tendencies and 95%CI range were calculated. The unit of analysis was based on the individual patient. For meta-analysis of the extracted data, the Open Meta Analyst software was employed.1919. Wallace BC, Issa JD, Thomas AT, Joseph L, Paul T, Schmid CH. Closing the gap between methodologists and end-users: r as a computational back-end. J Statist Software. 2012;49(5):1-15.

Evaluation of heterogeneity

In order to quantify the inconsistencies between the summed estimates, the I2=[(Q-df)/Q] × 100% test was used, in which “Q” is the χ2 statistic and “df” represents its degrees of freedom. This illustrates the percentage of variability in the estimates of the resulting effect of heterogeneity.2020. Deeks JJ, Higgins JP, Altman DG. Analysing data and undertaking meta-analyses. In: Higgins JP, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Chapter 9. The fixed model was used in the absence of substantial heterogeneity (I2<50%), and the random model when there was heterogeneity (I2≥50%).

RESULTS

The search strategy recovered 312 records: PubMed® with 177 references; EMBASE, 113 references; CENTRAL, 11 references; and LILACS, 11 references. Also analyzed were the references of articles relevant to potentially eligible studies and no additional references were located. No ongoing study was located. After the examination of titles and abstracts, eliminating the duplicates of these references, 28 articles were selected for full-text analysis. Ten articles were excluded for not meeting the inclusion criteria, and 18 studies were included in this systematic review (Figure 1).

Figure 1
Study flowchart

Design of the studies included

Only one randomized clinical trial (RCT)2121. Lima JP, Pompeo AC, Bezerra CA. Argus T® versus Advance® sling for postprostatectomy urinary incontinence: a randomized clinical trial. Int Braz J Urol. 2016;42(3):531-9. with a limited sample was identified in the search. The other studies included2222. Angulo JC, Arance I, Esquinas C, Dorado JF, Marcelino JP, Martins FE. Outcome measures of adjustable transobturator male system with pre-attached. Scrotal port for male stress urinary incontinence after radical prostatectomy: a prospective study. Adv Ther. 2017;34(5):1173-83.

23. Bauer RM, Rutkowski M, Kretschmer A, Casuscelli J, Stief CG, Huebner W. Efficacy and complications of the adjustable sling system ArgusT for male incontinence: results of a prospective 2-center study. Urology. 2015;85(2): 316-20.

24. 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.

25. Chung E, Smith P, Malone G, Cartmill R. Adjustable versus non-adjustable male sling for post-prostatectomy urinary incontinence: a prospective clinical trial comparing patient choice, clinical outcomes and satisfaction rate with a minimum follow up of 24 months. Neurourol Urodyn. 2016;35(4):482-6.

26. Cornel EB. Argus-T adjustable male sling: the influence of surgical technique on complications and short-term efficacy. Urol Int. 2016;96(2):164-70.

27. Friedl A, Mühlstädt S, Zachoval R, Giammò A, Kivaranovic D, Rom M, et al. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study. BJU Int. 2017;119(5):785-92.

28. Hoda MR, Primus G, Fischereder K, Von Heyden B, Mohammed N, Schmid N, et al. Early results of a European multicentre experience with a new self-anchoring adjustable transobturator system for treatment of stress urinary incontinence in men. BJU Int. 2013;111(2):296-303.

29. Kim SW, Walsh R, Berger Y, Kim JH. Male readjustable sling (MRS) system for postprostatectomy incontinence: experiences of 2 centers. Urology. 2016;88:195-200.

30. Leizour B, Chevrot A, Wagner L, Droupy S, Costa P. [Adjustable retropubic suburethral sling Remeex(®) in the treatment of male stress urinary incontinence: One-year results]. Prog Urol. 2017;27(4):238-43. French.

31. Lim B, Kim A, Song M, Chun JY, Park J, Choo MS. Comparing Argus sling and artificial urinary sphincter in patients with moderate post-prostatectomy incontinence. J Exerc Rehabil. 2014;10(5):337-42.

32. Mühlstädt S, Friedl A, Mohammed N, Schumann A, Weigand K, Kawan F, et al. Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation. World J Urol. 2017;35(1):145-51.

33. Navalón-Monllor V, Ordoño-Domínguez F, Pallás-Costa Y, Vilar-Castro LA, Monllor-Peidro ME, Juan-Escudero J, et al. Long-term follow-up for the treatment of male urinary incontinence with the Remeex system. Actas Urol Esp. 2016;40(9):585-91.

34. Romano SV, Metrebian SE, Vaz F, Muller V, D’Ancona CA, Souza EA, et al. [Long-term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years]. Actas Urol Esp. 2009;33(3):309-14. Spanish.

35. Romano SV, Huebner W, Rocha FT, Vaz FP, Muller V, Nakamura F. A transobturator adjustable system for male incontinence: 30-month follow-up of a multicenter study. Int Braz J Urol. 2014;40(6):781-9.

36. Seweryn J, Bauer W, Ponholzer A, Schramek P. Initial experience and results with a new adjustable transobturator male system for the treatment of stress urinary incontinence. J Urol. 2012;187(3):956-61.

37. Siracusano S, Visalli F, Favro M, Tallarigo C, Saccomanni M, Kugler A, et al. Argus-T sling in 182 male patients: short-term results of a multicenter study. Urology. 2017;110:177-83.
-3838. Sousa-Escandón A, Cabrera J, Mantovani F, Moretti M, Ioanidis E, Kondelidis N, et al. Adjustable suburethral sling (male remeex system) in the treatment of male stress urinary incontinence: a multicentric European study. Eur Urol. 2007;52(5):1473-9.were series of prospective and retrospective cases. The characteristics of the studies included are shown on table 5.

Table 5
Characteristics of the studies included

Participants

The studies included totaled up 1,170 participants, with ages varying between 46 and 89 years, with an approximate mean age of 70 years. Twelve studies included patients who had received prior radiation therapy, with a proportion of 5% to 44.7%, and eight included patients with prior PPI surgery, with a proportion of 11.8% to 36%. Twelve studies included patients with severe PPI, with a proportion of 7.8% to 76.5%.

Methodological quality of the studies included

The only RCT2121. Lima JP, Pompeo AC, Bezerra CA. Argus T® versus Advance® sling for postprostatectomy urinary incontinence: a randomized clinical trial. Int Braz J Urol. 2016;42(3):531-9.presented with low methodological quality, due to uncertain allocation, lack of blinding, and limited sample (Table 6).

Table 6
Evaluation of quality of the randomized clinical trial(21)

The 17 studies of the case series type presented with moderate to high quality (Table 7).

Table 7
Evaluation of quality of the studies included

Studies excluded

The study by Balci et al.,3939. 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. evaluated a type of sling that did not meet the inclusion criteria. The other studies were excluded for not having reported the primary outcome of this review or having presented participants with less than 12 months of follow-up4040. Dalpiaz O, Knopf HJ, Orth S, Griese K, Aboulsorour S, Truss M. Mid-term complications after placement of the male adjustable suburethral sling: a single center experience. J Urol. 2011;186(2):604-9.

41. Friedl A, Bauer W, Rom M, Kivaranovic D, Lüftenegger W, Brössner C. Sexuality and erectile function after implantation of an Adjustable Transobturator Male System (ATOMS) for urinary stress incontinence. A multi-institutional prospective study. Arch Ital Urol Androl. 2016;87(4):306-11.

42. González SP, Cansino JR, Portilla MA, Rodriguez SC, Hidalgo L, De la Peña J. First experience with the ATOMS(®) implant, a new treatment option for male urinary incontinence. Cent European J Urol. 2014;67(4):387-91.

43. Hübner 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):777-782.

44. Krause J, Tietze S, Behrendt W, Nast J, Hamza A. Reconstructive surgery for male stress urinary incontinence: experiences using the ATOMS(®) system at a single center. GMS Interdiscip Plast Reconstr Surg DGPW. 2014;3:15.

45. Kretschmer A, Hüsch T, Thomsen F, Kronlachner D, Obaje A, Anding R, Pottek T, Rose A, Olianas R, Friedl A, Hübner W, Homberg R, Pfitzenmaier J, Queissert F, Naumann CM, Wotzka C, Hofmann T, Seiler R, Haferkamp A, Bauer RM; Debates On Male Incontinence (DOMINO)-Project. Targeting Moderate and Severe Male Stress Urinary Incontinence With Adjustable Male Slings and the Perineal Artificial Urinary Sphincter: Focus on Perioperative Complications and Device Explantations. Int Neurourol J. 2017;21(2):109-15.

46. Miodrag A, Uroš B, Aleksandar A, Mirko J, Miodrag S, Boris K, et al. Retrospective evaluation of male slings for patients with urinary incontinence after radical prostatectomy - one surgeon’s experience. Acta Chir Iugosl. 2014;61(1):17-9.

47. Jiménez Parra JD, Cebrián Lostal JL, Hualde Alfaro A, Alvarez Bandrés S, García García D, Torres Varas L, et al. REMEEX® system for the treatment of male urinary stress incontinence: our experience. Actas Urol Esp. 2010; 34(9):802-5.
-4848. Romano SV, Metrebian SE, Vaz F, Muller V, D’Ancona CA, Costa de Souza EA, et al. An adjustable male sling for treating urinary incontinence after prostatectomy: a phase III multicentre trial. BJU Int. 2006;97(3):533-9.(Table 8).

Table 8
Characteristics of the excluded studied

Effect of intervention

The RCT2121. Lima JP, Pompeo AC, Bezerra CA. Argus T® versus Advance® sling for postprostatectomy urinary incontinence: a randomized clinical trial. Int Braz J Urol. 2016;42(3):531-9. compared the Argus T® (n=11) adjustable sling with the Advance® non-adjustable sling (n=11). After a follow-up period of 18 months, the authors verified cure (0-1 absorbent pad in 24 hours) in 77.8% of patients who received Argus T® and in 45.5% of the group that received the Advance® implant; this difference was not significant. There were also no significant differences in the rates of complications between the two intervention groups.

Of the case series studies included, five2222. Angulo JC, Arance I, Esquinas C, Dorado JF, Marcelino JP, Martins FE. Outcome measures of adjustable transobturator male system with pre-attached. Scrotal port for male stress urinary incontinence after radical prostatectomy: a prospective study. Adv Ther. 2017;34(5):1173-83.,2727. Friedl A, Mühlstädt S, Zachoval R, Giammò A, Kivaranovic D, Rom M, et al. Long-term outcome of the adjustable transobturator male system (ATOMS): results of a European multicentre study. BJU Int. 2017;119(5):785-92.,2828. Hoda MR, Primus G, Fischereder K, Von Heyden B, Mohammed N, Schmid N, et al. Early results of a European multicentre experience with a new self-anchoring adjustable transobturator system for treatment of stress urinary incontinence in men. BJU Int. 2013;111(2):296-303.,3232. Mühlstädt S, Friedl A, Mohammed N, Schumann A, Weigand K, Kawan F, et al. Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation. World J Urol. 2017;35(1):145-51.,3636. Seweryn J, Bauer W, Ponholzer A, Schramek P. Initial experience and results with a new adjustable transobturator male system for the treatment of stress urinary incontinence. J Urol. 2012;187(3):956-61.evaluated the ATOMS® model, five2424. 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.

25. Chung E, Smith P, Malone G, Cartmill R. Adjustable versus non-adjustable male sling for post-prostatectomy urinary incontinence: a prospective clinical trial comparing patient choice, clinical outcomes and satisfaction rate with a minimum follow up of 24 months. Neurourol Urodyn. 2016;35(4):482-6.
-2626. Cornel EB. Argus-T adjustable male sling: the influence of surgical technique on complications and short-term efficacy. Urol Int. 2016;96(2):164-70.,3131. Lim B, Kim A, Song M, Chun JY, Park J, Choo MS. Comparing Argus sling and artificial urinary sphincter in patients with moderate post-prostatectomy incontinence. J Exerc Rehabil. 2014;10(5):337-42.,3434. Romano SV, Metrebian SE, Vaz F, Muller V, D’Ancona CA, Souza EA, et al. [Long-term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years]. Actas Urol Esp. 2009;33(3):309-14. Spanish. Argus®, three2323. Bauer RM, Rutkowski M, Kretschmer A, Casuscelli J, Stief CG, Huebner W. Efficacy and complications of the adjustable sling system ArgusT for male incontinence: results of a prospective 2-center study. Urology. 2015;85(2): 316-20.,3535. Romano SV, Huebner W, Rocha FT, Vaz FP, Muller V, Nakamura F. A transobturator adjustable system for male incontinence: 30-month follow-up of a multicenter study. Int Braz J Urol. 2014;40(6):781-9.,3737. Siracusano S, Visalli F, Favro M, Tallarigo C, Saccomanni M, Kugler A, et al. Argus-T sling in 182 male patients: short-term results of a multicenter study. Urology. 2017;110:177-83. Argus T®, three3030. Leizour B, Chevrot A, Wagner L, Droupy S, Costa P. [Adjustable retropubic suburethral sling Remeex(®) in the treatment of male stress urinary incontinence: One-year results]. Prog Urol. 2017;27(4):238-43. French.,3333. Navalón-Monllor V, Ordoño-Domínguez F, Pallás-Costa Y, Vilar-Castro LA, Monllor-Peidro ME, Juan-Escudero J, et al. Long-term follow-up for the treatment of male urinary incontinence with the Remeex system. Actas Urol Esp. 2016;40(9):585-91.,3838. Sousa-Escandón A, Cabrera J, Mantovani F, Moretti M, Ioanidis E, Kondelidis N, et al. Adjustable suburethral sling (male remeex system) in the treatment of male stress urinary incontinence: a multicentric European study. Eur Urol. 2007;52(5):1473-9. the Remeex®, and one,2929. Kim SW, Walsh R, Berger Y, Kim JH. Male readjustable sling (MRS) system for postprostatectomy incontinence: experiences of 2 centers. Urology. 2016;88:195-200. MRS®. The follow-up period varied from 12 months to 46 months. Heterogeneity was verified in the clinical characteristics of patients included as to gravity of PPI, radiation, and surgery for prior PPI.

The primary outcome, cure, defined as 24-hour pad test equal to zero, was reported by three studies,2323. Bauer RM, Rutkowski M, Kretschmer A, Casuscelli J, Stief CG, Huebner W. Efficacy and complications of the adjustable sling system ArgusT for male incontinence: results of a prospective 2-center study. Urology. 2015;85(2): 316-20.,2626. Cornel EB. Argus-T adjustable male sling: the influence of surgical technique on complications and short-term efficacy. Urol Int. 2016;96(2):164-70.,3232. Mühlstädt S, Friedl A, Mohammed N, Schumann A, Weigand K, Kawan F, et al. Five-year experience with the adjustable transobturator male system for the treatment of male stress urinary incontinence: a single-center evaluation. World J Urol. 2017;35(1):145-51. and the meta-analysis resulted in a cure rate of 53% (95%CI: 45%-62%; 132 participants). This analysis did not present with heterogeneity (I2=0%, p=0.36), and the fixed model of analysis was used (Figure 2).

Figure 2
Meta-analysis of cure as 0 pad-test in 24 hours

For the primary outcome, defined as cure meaning 0-1 pad in 24 hours, 15 studies were included. A meta-analysis demonstrated cure of 69% (95%CI: 57%-80%; 1,038 participants). This analysis presented with heterogeneity (I2=95.2%, p<0.01) and, thus, the random model was used (Figure 3).

Figure 3
Meta-analysis of cure as 0-1 pads test in 24 hours

The proportion of participants who required tension adjustments in the sling during follow-up was reported in nine studies,2222. Angulo JC, Arance I, Esquinas C, Dorado JF, Marcelino JP, Martins FE. Outcome measures of adjustable transobturator male system with pre-attached. Scrotal port for male stress urinary incontinence after radical prostatectomy: a prospective study. Adv Ther. 2017;34(5):1173-83.,2424. 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.,3030. Leizour B, Chevrot A, Wagner L, Droupy S, Costa P. [Adjustable retropubic suburethral sling Remeex(®) in the treatment of male stress urinary incontinence: One-year results]. Prog Urol. 2017;27(4):238-43. French.,3131. Lim B, Kim A, Song M, Chun JY, Park J, Choo MS. Comparing Argus sling and artificial urinary sphincter in patients with moderate post-prostatectomy incontinence. J Exerc Rehabil. 2014;10(5):337-42.,3333. Navalón-Monllor V, Ordoño-Domínguez F, Pallás-Costa Y, Vilar-Castro LA, Monllor-Peidro ME, Juan-Escudero J, et al. Long-term follow-up for the treatment of male urinary incontinence with the Remeex system. Actas Urol Esp. 2016;40(9):585-91.

34. Romano SV, Metrebian SE, Vaz F, Muller V, D’Ancona CA, Souza EA, et al. [Long-term results of a phase III multicentre trial of the adjustable male sling for treating urinary incontinence after prostatectomy: minimum 3 years]. Actas Urol Esp. 2009;33(3):309-14. Spanish.
-3535. Romano SV, Huebner W, Rocha FT, Vaz FP, Muller V, Nakamura F. A transobturator adjustable system for male incontinence: 30-month follow-up of a multicenter study. Int Braz J Urol. 2014;40(6):781-9.,3737. Siracusano S, Visalli F, Favro M, Tallarigo C, Saccomanni M, Kugler A, et al. Argus-T sling in 182 male patients: short-term results of a multicenter study. Urology. 2017;110:177-83.,3838. Sousa-Escandón A, Cabrera J, Mantovani F, Moretti M, Ioanidis E, Kondelidis N, et al. Adjustable suburethral sling (male remeex system) in the treatment of male stress urinary incontinence: a multicentric European study. Eur Urol. 2007;52(5):1473-9.varying from 19.4% to 60%. The mean readjustments necessary varied from 1.5 to 4.5 times.

The rate of extrusion in the postoperative phase was reported in 16 studies, and meta-analysis resulted in 9.8% (95%CI: 6.5%-13.1%; 1,134 participants; I2=72.6%, random modelo) (Figure 4).

Figure 4
Meta-analysis of sling extrusion rate in the postoperative period

The most often reported complications were local postoperative pain of implantation, with a frequency of 1.7% to 30%, and local infection, with frequencies of 4% to 12%.

Table 9 displays a summary of results with the quality of evidence.

Table 9
Summary of results

DISCUSSION

The quality of evidence of effectiveness and safety of the adjustable slings in the treatment of PPI is low. Only one RCT with a high risk of bias was located and concluded the equivalence of effectiveness of adjustable and non-adjustable slings. All the other studies were case studies − most with a small sample size. Additionally, the studies made were heterogeneous in the groups studied, with patients of various levels of intensity of urinary incontinence and a history of radiation and prior operations. Only the meta-analysis for 0 pad in 24 hours demonstrated homogeneity with an effectiveness of 53%. For the outcome of 0 to 1 pad in 24 hours, the meta-analysis presented with heterogeneity and resulted in an effectiveness of 69%. The risk factors observed in the studies for unsuccessful surgery included prior pelvic irradiation, severity of PPI, and prior operations. The meta-analysis of sling extrusion rate during follow-up was 9.8%, and the most often reported complications were pain and local infection.

We believe that this systematic review was comprehensive, since we investigated the major databases of studies, including one relevant to our region (LILACS). There was no restriction as to language or date of publication. Nonetheless, the localization of studies, most of them descriptive, resulted in low quality evidence, and highlighted the need for research in the area.

The results observed in this review were similar to those noted in a systematic review with metanalysis performed by Chen et al.,4949. Chen YC, Lin PH, JouYY, Lin VC. Surgical treatment for urinary incontinence after prostatectomy: a meta-analysis and systematic review. PLoS One. 2017;12(5):e0130867. Review. which jointly analyzed all types of sling and found a cure rate of 60% (95%CI: 51%-67%).

Implantation of an artificial urinary sphincter has so far been considered the gold standard of surgical treatment for PPI, especially for cases of severe incontinence. A systematic review published by Van der Aa et al.,5050. Van der Aa F, Drake MJ, Kasyan GR, Petrolekas A, Cornu JN; Young Academic Urologists Functional Urology Group. 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. Review. included case series studies with a minimum of follow-up of 2 years and noted effectiveness of 0 to 1 pad in 24 hours of 79% (95%CI: 60%-100%), with a rate of erosion and infection of 8.5%, mechanical failure of 6.2%, and need for reintervention of 26%. These results show that when this is the option to be considered, the adjustable slings display similar effectiveness and safety profiles, even when including patients with severe and irradiated cases of PPI.

A national study in the United States5151. Chughtai B, Sedrakyan A, Isaacs AJ, Mao J, Lee R, Te A, et al. National study of utilization of male incontinence procedures. Neurourol Urodyn. 2016; 35(1):74-80. assessed 1,246 beneficiaries of Medicare between 2000 and 2011 diagnosed with PPI, and identified that the mean proportion of 35% of patients that received an artificial urinary sphincter implantation maintained stability during the decade, but the proportion of patients that received the sling increased drastically, from 14.8% to 51.4%. Another study5252. 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. evaluated the preference of the patient with PPI, and of 24 patients informed about the pros and cons of the artificial urinary sphincter implantation and of the sling, 22 (92%) chose the sling; of 63 patients who, due to their characteristics had a medical indication for the artificial sphincter implant, even so, 25% chose the sling. The rationale for the choice of the sling was the preference of avoiding handling of the mechanical equipment. Recent systematic reviews of surgical treatments for PPI concluded that the adjustable slings should be considered as a preferential option for patients with light to moderate incontinence, and in those who do not desire or cannot receive the implantation of the artificial urinary sphincter.1313. Comiter CV, Dobberfuhl AD. The artificial urinary sphincter and male sling for postprostatectomy incontinence: which patient should get which procedure? Investig Clin Urol. 2016;57(1):3-13. Review.,1414. Kretschmer A, Hübner W, Sandhu JS, Bauer RM. Evaluation and management of postprostatectomy incontinence: a systematic review of current literature. Eur Urol Focus. 2016;2(3):245-59. Review.

Thus, when indicating surgical treatment for PPI, the patient should be informed about the current limited quality of evidence in the area, success rates, and complications of each option, and along with the physician, evaluate the best procedure to be adopted.

CONCLUSION

Low-quality evidence indicates that the adjustable slings are effective for treatment of post-prostatectomy urinary incontinence, with a frequency of adverse events similar to those of the surgical option considered the gold standard (implantation of the artificial urinary sphincter). Further randomized comparative studies are warranted, with a standardized definition of severity of urinary incontinence, as well as methods of outcome measurements. Other studies should enable the analysis of a subgroup of patients, according to severity, irradiation, and prior surgeries, to indicate better the procedure according to the characteristics and desire of each patient.

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Publication Dates

  • Publication in this collection
    23 Sept 2019
  • Date of issue
    2019

History

  • Received
    2 Apr 2018
  • Accepted
    8 Apr 2019
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