Long term functional outcome and complications of advance®/advance xp® male suburethral slings in the management of post-prostatectomy incontinence: multicenter prospective ten-year follow-up study

Riaza M1, Collado A2, Resel L3, Romero A4, Wong A2, Dominguez-Escrig J2, Gomez-Ferrer A2, Ramirez-Backhaus M2, Marenco J2, Garcia A5, Fernandez T4, Moreno J3, Gallego J1, Casanova J2

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 61
Male Lower Urinary Tract Symptoms
Scientific Podium Short Oral Session 5
Thursday 8th September 2022
12:00 - 12:07
Hall D
Stress Urinary Incontinence Male Incontinence Pad Test Surgery
1. Galdakao-Usansolo Hospital, Bilbao, Spain, 2. Fundación IVO, Valencia, Spain, 3. Hospital Clínico San Carlos de Madrid, 4. Hospital Universitario Morales Meseguer, Murcia, Spain, 5. Fundación IVO, Valencia,Spain
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Abstract

Hypothesis / aims of study
The AdVance®/AdVance XP ® suburethral transobturator male slings are considered an option for the treatment of male stress urinary incontinence (SUI) post-radical prostatectomy (1).
According to 6th International Consultation on Incontinence the male slings are an acceptable surgical approach with several-year follow-up data supporting their safety and efficacy in men with mild to moderate degrees of SUI.
To our knowledge, there are no articles about more than 10 years of follow-up related to male urethral slings.
The aim of our paper is to evaluate the effects on the urethral bulb after ten years of compression/mobilization. We focused on the eventual deterioration of continence in those cured by surgery and later complications such urethral sling erosion(2).
Study design, materials and methods
An observational, prospective, multicenter study 

Inclusion period: we considered initially 111 patients with SIU after radical prostatectomy treated with ADVANCE®/ADVANCE XP male suburethral slings before February 2012.
Patients included: fulfilling 10 years of follow-up until February 2022. 
Patients with 24-h Pad test <400 g, continents at night and at rest who also resulted in positive “repositioning test” were considered for sling (1). Exceptionally, 24-h Pad test >400g were accepted in patients who rejected artificial sphincter. Patients were only considered after failed pelvic floor rehabilitation.
Exclusion criteria: patients without complete follow-up were excluded. The presence of urodynamic detrusor overactivity or previous surgery was not considered as contraindication.
Preoperative assessment: continence was assessed by means of the 24-hour pad weight test and Patient-reported outcome measures (PROMs) with the International Consultation on Incontinence Questionnaire Short Form (ICIQ-UI SF). A preoperative urodynamic assessment, according to the International Continence Society criteria, and flexible cystoscopy were performed in all cases. Urgency was defined as the complaint of a sudden compelling desire to pass urine which is difficult to defer.
Written informed consent and negative urine cultures before surgery were mandatory before surgery. Preoperative antibiotic prophylaxis was administered in all cases. 
Surgical technique: surgery has been previously described (3). Briefly, the bulbospongiosus muscle is incised in its longitudinal axis and the central tendon it is sectioned distally. A helical rounded tip needle is introduced along the lateral edge of the pubic ramus, pointing towards, and coming out at the uppermost corner between the urethral bulb and inferior pubic ramus. The edge of the proximal fap of the sling should be located at the origin of the central tendon previously marked. Postoperatively, urinary catheter is leaved in place for 48 h and then the patient is discharged. 
Follow-up: outcome was assessed at 3 month after surgery. The primary outcome was a pad count, with cure defined as no longer requiring pads; all other cases were defined as failures.
Follow-up was carried out once every 3 months during the first year and once every 6 months thereafter, in parallel to the oncological follow-up (PSA, 24h-PW and ICIQ-UI SF). Surgical complications (<90 days) were evaluated according to Clavien-Dindo classification. The reintervention rate was considered as any case requiring invasive treatment. The loss of continence was defined as the need for pads in a patient initially cured. Patient characteristics, peri-operative data, complication, and revision rate were analyzed prospectively. 
Statistics: data analysis was performed using Stata (version 13.1, StataCorp, College Station, TX). Categorical variables were summarized using frequencies and percentages and analyzed using the Chi-squared test. Continuous variables were analyzed using means, medians, and standard deviations. We examined continuous variables used Student’s t test and One-way analysis of variance adjusted for multiple comparisons, if necessary. The Wilcoxon test was used to analyze variables with non-normal distributions. All tests were two-sided, and p values less than 0.05 were considered statistically significant. A binary logistic model including all significant covariates was used to validate the results.
Ethical Approval: all procedures involving human participants were performed in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
The data from this study are based on “Fundación IVO Registry for Patients Undergoing Sling or Artificial Urinary Sphincter After Prostate Cancer Treatment”, which has been registered with ClinicalTrials.gov, Identifier: NCT02901392.
Results
One hundred and eleven patients underwent surgery before February 2012. Twenty-four did not complete the minimum follow-up. Therefore, finally the study group was 87 patients. Median follow-up was 136.6 months (range:121.9-170.5).
Baseline patient characteristics:  with a median age of 66 years (range: 52-83), 27  patients had undergone an open retropubic radical prostatectomy, 12 patients robotic and 48 patients  laparoscopic prostatectomy. No incontinence surgery was previously performed in any patient. Median 24h-Pad test was 199 grams (range: 15-600). Seventeen patients (19.54%) presented preoperative urgency. Urodynamic study was performed in 53 patients: 23 patients-detrusor overactivity, 5 patients-low bladder compliance and 25 without findings in cystometry. 
Postoperative complications: there were not intra-operative complications. A total of 19 early postoperative complications were reported (21.83%): 8 patients presented perineal-scrotal pain (Clavien I) and 11 patients with acute urinary retention (Clavien II). To date, there are no reports of recurrent anastomotic stricture, urethral sling erosion or any other recognized late complications. 
Cure rate: 59 patients were considered cured (67.81%).
Surgery requirement during follow-up: no patient in this series required surgical review during follow-up.
Loss of continence during follow-up: Of the 59 patients initially cured, 17 patients (28.81%) lost continence during follow-up (Figure 1). Five of 59 patients loss continence before 3 years (8.47%), 9 of 59 patients before 5 years (15.25%) and 16 of 59 patients before 10 years (27.12%).
Interpretation of results
These results demonstrate the effectiveness of suburethral mesh in the treatment of SUI after prostatectomy.
It is a surgery with a low risk of complications, especially serious complications.
This is a multicenter study with a long follow-up (more than 10 full years) and therefore its results are reliable.
Initial results remain relatively stable during follow-up. Therefore, continuous compression/mobilization of the bulbar urethra maintains its effectiveness.
This long-term compression/mobilization does not translate clinically into a risk of urethral erosion or late complications
Concluding message
The AdVance®/AdVance XP ® Male Sling System is a safe and effective treatment for men with SUI after radical prostatectomy.
Understanding relative rates of male slings during long term follow-up can help clinicians better counsel SUI patients of surgical risks, thus promoting informed decision making and appropriate patient expectations
Figure 1 Loss of continence during follow-up
References
  1. Rehder P, Gozzi C. Transobturator sling suspension for male urinary incontinence including post-radical prostatectomy. Eur Urol. 2007;52(3):860-6
  2. Ye H, Haab F, de Ridder D, Chauveau P, Becker A, Arano P, et al. Effectiveness and Complications of the AMS AdVance Male Sling System for the Treatment of Stress Urinary Incontinence: A Prospective Multicenter Study. Urology. 2018;120:197-204.
  3. Collado A, Resel L, Dominguez-Escrig JL, Gomez-Ferrer A, Rubio-Briones J, Solsona E. AdVance/AdVance XP transobturator male slings: preoperative degree of incontinence as predictor of surgical outcome. Urology. 2013;81(5):1034-9.
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee COMITE ETICO DE INVESTIGACION CLINICA DE LA FUNDACION INSTITUTO VALENCIANO DE ONCOLOGIA Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100229
DOI: 10.1016/j.cont.2022.100229

02/11/2024 23:33:42