Comparison of outcomes for suburethral male sling and artificial urinary sphincter: single center prospective five-year follow-up study.

RIaza M1, Collado A2, Wong A2, Dominguez-Escrig J2, Gomez-Ferrer A2, Ramirez-Backhaus M2, Marenco J2, Garcia A2, Gallego J1, Casanova J2

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 255
Open Discussion ePosters
Scientific Open Discussion Session 18
Friday 9th September 2022
11:20 - 11:25 (ePoster Station 2)
Exhibition Hall
Stress Urinary Incontinence Male Surgery Pad Test Incontinence
1. Galdakao-Usansolo Hospital, Bilbao, Spain., 2. Fundación IVO, Valencia, Spain.
In-Person
Presenter
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Poster

Abstract

Hypothesis / aims of study
Stress Urinary incontinence (SUI) is a common complication after prostate surgery (mainly after radical prostatectomy) or prostate radical radiotherapy.
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According to 6th International Consultation on Incontinence Artificial Urinary sphincter (AUS) is the preferred treatment for properly selected men who have moderate to severe stress incontinence after radical prostatectomy. Moreover, the AUS has the longest record of safety and efficacy and we know the long-term complications. Male suburethral 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 it would be interesting to know the long-term evolution of this constant male urethral compression/realignment.
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There are few comparative studies between both techniques given their use in relatively distinct populations and the first randomized comparative study has recently been published, although at the moment, with a follow-up of 1 year (1) .
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The aim of the study is to evaluate and compare efficacy, the long-term functional outcomes and worsening continence of slings and AUS implants in men with stress SUI.  All surgeries were performed by the same surgeon, in the same hospital, with the same preoperatory evaluation and the same follow-up protocol to avoid all possible biases.
Study design, materials and methods
Single-center experience. All data were collected prospectively.
Inclusion period: we considered initially 315 patients with SIU after radiotherapy treatment or prostate surgery treated with sling (sling group) or AUS (AUS group) before February 2017.
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Patients included: fulfilling 5 years of follow-up until February 2022. Both primary and secondary implants were included.
Exclusion criteria: patients without complete follow-up were excluded
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Preoperative assestment: 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. 
All implants AMS 800®, ADVANCE® and ADVANCE XP ® were performed by a single experienced surgeon. Written informed consent and negative urine cultures before surgery were mandatory before surgery. Preoperative antibiotic prophylaxis was administered in all cases. 
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Surgical technique: Both surgeries have been previously described (2) (3).
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AdVance®/AdVance XP®: the fibrous portion of the central tendon was incised. A helical rounded tip needle was introduced along the lateral edge of the pubic ramus. The edge of the proximal flap 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.
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Artificial urinary sphincter  AMS-800® (Boston Scientific, Marlborough, United States): surgical technique consisted of a perineal incision for cuff placement around the bulbous urethra (preserving the bulbospongiosus muscle) and a transverse abdominal incision for pressure regulating balloon (61 to 70 cm H2O pressure). The sphincter was activated in the office six weeks later.  
Follow-Up: outcome was assessed at 3 month postoperative. The primary outcome was a pad count, with cure defined as no longer requiring pads; all other cases were defined as failures. The loss of continence was defned as the de novo need for pads in a patient who was initially cured.
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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-pad test and ICIQ-UI SF). Postoperative complications (<90 days) were registered by Clavien-Dindo classification. The reintervention rate was considered as any case requiring invasive treatment during follow-up. 
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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
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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
Three hundred fifteen patients underwent surgery before February 2017, 150p in sling group and 165p in AUS group. Thirty-seven did not complete the minimum follow-up. Therefore, finally the study group was 278 patients (134 slings and 144 AUS). Median follow-up was 92.86 months (61.46-216.83m)
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Preoperative status: quantitative and qualitative variables are shown in Figure#1
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Cure rate: 107/134p (79.85%) in sling group  and 100/144p (69.44%) in AUS group. 
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Postoperative complications: There were not intra-operative complications. We registered early postoperative complications in 21p in sling group (3 perineal pain -Clavien I and 18 urinary retention-Clavien II) and 21 AUS group (5 perineal hematoma Clavien I, 14 Clavien II 12 urinary retention and 2 urinary infection and 2 patiens  urethral erosion-Clavien IIIa). 
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Surgery requirement during follow-up: 28 patients required surgery during follow-up. Two patients (1.34%) in sling group (sling section due to urinary retention) and 26p (18.05%) in the AUS group (including nine late urethral erosions during follow-up). There was not urethral sling erosion in the sling group.
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Loss of continence during follow-up: Of the 207 patients initially cured, 68 patients (32.85%) lost continence during follow-up (Figure #2), 17 patients in the sling group (in 11 cases with stress incontinence) and 51 patients (17 cases due to mechanical failure) in the AUS group. Kaplan-Meier analysis showed a statistically significant difference (p<0.05).
Interpretation of results
Although, this is not a randomized trial, prospectively collected data shows that, with the correct indication the results obtained with the different techniques are similar.
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The rate of complications in the early postoperative period are similar. However, the surgical revisión rate during the follow-up in AUS group is higher.
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The continence obtained in sling group remains acceptable during follow-up. Our long-term data demonstrate the rate of surgical revision described in the literature for patients in the AUS group.
Concluding message
Taking into account that the selected patients are different in terms of baseline characteristics and degree of incontinence, our study suggests male slings are safer and more effective than artificial urinary sphincter during long-term follow-up for the management of post-prostatectomy patients with SUI. 
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Understanding relative rates of male slings and AUS complications can help clinicians better counsel SUI patients of surgical risks, thus promoting informed decision making and appropriate patient expectations.
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Prospective trial comparing both systems in patients with a mid-grade urinary incontinence after radical prostatectomy seems to be necessary to answer the question if there are clear factors favoring one system in this distinct patient population
Figure 1
Figure 2
References
  1. Constable L, Cotterill N, Cooper D, Glazener C, Drake MJ, Forrest M, et al. Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial. Trials. 2018;19(1):131.
  2. Collado Serra A, Dominguez-Escrig J, Gomez-Ferrer A, Batista Miranda E, Rubio-Briones J, Solsona Narbon E. Prospective follow-up study of artificial urinary sphincter placement preserving the bulbospongiosus muscle. Neurourol Urodyn. 2016.
  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 INSTITUO VALENCIANO DE ONCOLOGIA Helsinki Yes Informed Consent Yes
19/11/2024 18:05:14