The Virtue European trial for urinary incontinence after prostatectomy: 3-year outcomes

Madurga Patuel B1, Elzevier H2, Wagner L3, Bottero D4, Ferro M4, Hegarty P5, Shabbir M6, Yiou R7, Naumann C8, Arano P9, Damm J10, Everaert K11, Chartier-Kastler E12, Ryckebusch H13, Roumeguère T14

Research Type

Clinical

Abstract Category

Male Stress Urinary Incontinence (Post Prostatectomy Incontinence)

Abstract 281
Male Stress Urinary Incontinence
Scientific Podium Short Oral Session 17
Thursday 5th September 2019
09:52 - 10:00
Hall G1
Grafts: Synthetic Clinical Trial Stress Urinary Incontinence Male Surgery
1.Department of Urology, Puerta del Mar University Hospital, Cádiz, Spain, 2.Department of Urology, Leiden University Medical Center, Leiden, The Netherlands, 3.Department of Urology-Andrology, Caremeau University Hospital, Nîmes, France, 4.European institute of Oncology, Milano, Italy, 5.Department of Urology, Mater Private Hospital, Dublin, Ireland, 6.Department of Urology, Guy’s Hospital, Guy's and St Thomas' NHS Foundation Trust, London, United-Kingdom, 7.Department of Urology, Henri Mondor University Hospital, Créteil, France, 8., Department of Urology and Pediatric Urology, Schleswig-Holstein University Hospital, Kiel Campus, Kiel, Germany, 9.Departement of Urology, Nephrology and Andrology, Puigvert foundation, Autonomous University Hospital of Barcelona, Cartegena, Barcelona, Spain, 10.Department of Urology, Heilig Geist Hospital, Cologne, Germany, 11.Department of Urology, University Hospital, Gent, Belgium, 12.Department of Urology, Pitié-Salpêtrière University Hospital, Paris, France, 13.Medical Affairs Office, Coloplast, Le Plessis-Robinson, France, 14.Department of Urology, University Clinics of Brussels, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium
Presenter
B

Blanca Madurga Patuel

Links

Abstract

Hypothesis / aims of study
Virtue (Coloplast A/S, Humlebaek, Denmark) is a quadratic large pore, knitted polypropylene male sling with four transobturator and prepubic arms providing a proximal relocation and perineal compression of the urethra. Tertiary reference centers for male urinary incontinence management were asked to include and follow their first patients (including device run-in subjects) during 3 years. The aim of this prospective, single-cohort study was to confirm 36-month efficacy and gather post-marketing safety data
Study design, materials and methods
We analyzed data from 117 incontinent men after prostatectomy (ITT population; 66,5 ± 6,7 years) in 14 urological departments from August 27, 2012 to February 23, 2015. Patients with predominant overactive bladder, previous incontinence surgery, urethral stricture, or radiation history were excluded. Objective success, as primary endpoint, was defined as >50% decrease in 24h Pad Weight Test (PWT). A pad weight < 1,3g defined cured patient. Patient-reported improvement using the PGI-I index and satisfaction index defined the subjective success. Evaluation was performed at 1, 3, 6, 12, 24 and 36 months. The ICIQ-SF was completed. Uroflowmetry (Qmax) and post void residual urine volume (PVR) were systematically measured. Complications of surgery were reported. A subgroups analysis was secondarily performed by baseline severity incontinence on 24h PWT: mild (<100g), moderate (100-400g) and severe (> 400g), pads usage (0 or 1 pad for security; 1 or 2 soiled pads; 3 or 4; 5 or more) and BMI.
Results
Preoperatively mild, moderate and severe incontinence according to 24h PWT were 52 (46%), 47 (41%) and 15 (13%) respectively. Low, normal and over weighted patients were 36 (32%), 58 (51%) and 19 (17%) respectively. At baseline mean and median urinary loss were 227 g ± 292 (5-1471g) and 113 g (54-296) respectively. At 36 months, objective and subjective successes were achieved in 72% and 69% (29% very much; 40% much; 21% a little better) respectively. Satisfaction was achieved in 69% of patients. Mean and median urinary leakage in 24h PWT were 72 g ± 158 and 7 g respectively (Table 1). No difference per baseline incontinence severity, BMI and pads usage were found at 36 Months (Table 2). Median ICIQ-UI SF score decreased from 16 (mean 15; range 6-21) to 9 (mean 9; range 0-21) with no significant degradation of assessed parameters registered from 3 to 36 months follow up (table 1). No significant change on Qmax and PVR were reported. The main postoperative complications were discomfort or pain: perineal of whom 9 patients (7,7%) required a specific antalgic treatment and 1 (0,8%) a sling revision, genital paresthesia or hypoesthesia (11; 9,4%), post procedural hematoma (4; 3,4%), transient urinary retention (9; 7,7%) and micturition urgency or pollakiuria or hypertonic bladder (12; 10,2%).
Interpretation of results
This prospective series including the device run-in phase represents the first experience with the device in Europe. They may likely improve with growing experience. Due to a heterogeneity of the definition of “cure/continent patient” on the 24-hour pad weight test in the literature, results may vary and make comparison difficult. A consensual definition is needed. Its effect remains during the 3-year follow-up. As an exploratory study, it’s interesting to underline that Virtue 36-month results showed no difference according to incontinence severity (24H PWT and number of pads) and BMI. The complications rate is similar to previous published in literature with quadratic sling.
Concluding message
The Virtue quadratic male sling is a safe and efficacious mesh surgical treatment for male stress urinary incontinence. Long term follow-up at least 5 years should confirm these promising findings. Further investigations should affirm exploratory results in moderate to severe patients and overweight patients and justify the use of Virtue male sing as first line treatment before artificial urinary sphincter in these patients.
Figure 1 Table 1: 36-Month objective and subjective assessment
Figure 2 Table 2: Statistical comparisons of 36-Month responders' rate
References
  1. Bauer RM, Gozzi C, Klehr B, Kretschmer A, Grabbert M, Rehder P, May F, Stief CG, Gebhartl P, Homberg R. AdVanceXP male sling: 2-year results of a multicentre study. World J Urol. 2016 Jul;34(7):1025-30.
  2. Moore K, Allen M, Voaklander DC. Pad tests and self-reports of continence in men awaiting radical prostatectomy: establishing baseline norms for males. Neurourol Urodyn. 2004;23(7):623-6.
  3. Hoda MR, Primus G, Fischereder K, Von Heyden B, Mohammed N, Schmid N, Moll V, Hamza A, Karsch JJ, Brössner C, Fornara P, Bauer W. 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 Feb;111(2):296-303
Disclosures
Funding Coloplast Clinical Trial Yes Registration Number ClinicalTrials.gov NCT01608789 RCT No Subjects Human Ethics Committee Hospital Universitario Puerta del mar, Cadiz 27/09/2013; CPP île de France 8: 12 04 38; Erasme, Brussels: P2012/183; NRES committee South West – Exeter, Bristol: 12/SW/0204; Milano: IEO 70 – virtue male sling european study SU012 31/03/2014; LUMC Leiden: P12.073; Master Misericordiae University Hospital N°351402 Charity n°CHY203 74 Upper Dorset street Dublin 1 ref 1/378/1647;Köln: 2012113; AZ Kiel: B 209/12; UZ Gent: 2012/359; Barcelona: 2011/40; Helsinki Yes Informed Consent Yes