The Virtue European trial for urinary incontinence after prostatectomy: Intermediate 1-year outcomes

Madurga-Patuel B1, Elzevier H2, Wagner L3, Hegarty P4, Bottero D5, Yiou R6, Naumann C M7, Damm J8, Gutierrez Ruiz C9, Everaert K10, Chartier-Kastler E11, Roumeguere T12

Research Type

Clinical

Abstract Category

Male Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 255
Male Incontinence
Scientific Podium Short Oral Session 13
Wednesday 29th August 2018
17:07 - 17:15
Hall C
Male Incontinence Surgery New Devices Pad Test
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. Department of Urology, Mater Private Hospital, Dublin, Ireland, 5. Department of Urology, European institute of Oncology, Milano, Italy, 6. Department of Urology, Henri Mondor University Hospital, Créteil, France, 7. Department of Urology and Pediatric Urology, Schleswig-Holstein University Hospital, Kiel Campus, Kiel, Germany, 8. Department of Urology, Heilig Geist Hospital, Cologne, Germany, 9. Department of Urology Nephrology and Andrology, Puigvert Foundation, Autonomous University of Barcelona, Barcelona, Spain, 10. Department of Urology, University Hospital, Gent, Belgium, 11. Department of Urology, Pitié-Salpêtrière University Hospital, Paris, France, 12. 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
Fourteen tertiary reference centers for male urinary management participated to a prospective 3-year trial (ClinicalTrials.gov NCT01608789) about post radical prostatectomy urinary incontinence treatment with the Virtue® male sling (Coloplast A/S, Humlebaek, Denmark). Virtue® Male Sling System (figure #1) is a quadratic large pore, knitted polypropylene sling with four transobturator and prepubic arms providing a proximal relocation and perineal compression of the urethra (1). This work evaluates intermediate 12-month efficacy and safety data.
Study design, materials and methods
One hundred and eighteen patients (ITT population) were included from August 2012 to February 2015 (including device run-in subjects). 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 24 hour Pad Weight Test and subjective success, as secondary endpoint, was defined as patient global improvement reported using the PGI-I index (Patient Global Impression of Improvement Index). The International Consultation on Incontinence Questionnaire short form (ICIQ-SF) was also completed. Subgroups were analyzed by baseline severity incontinence on 24 hour Pad Weigh Test: mild (<100g), moderate (100-400g) and severe (> 400g) and Body Mass Index. Evaluation was performed at 1, 3, 6, 12, 24 and 36 months. Uroflowmetry (Qmax) and postvoid residual urine volume (PVR) were systematically measured. Adverse events related to the device or the procedure (AE) were reported.
Results
At the baseline, the mean population age was 66,5 ± 6,7 years.  Preoperatively mild, moderate and severe incontinence were 53 (46%), 47 (41%) and 15 (13%) respectively (3 Missing Data). Low, normal and over weighted patients were 36 (31%), 59 (52%) and 19 (17%) respectively (4 MD). The mean and median urinary loss were 227 g ± 292 (5-1471g) and 120 g (45-300) respectively. At 12 months, objective and subjective successes were achieved in 73% and 78% (24,7% very much better; 40% much better) respectively. Mean and median urinary leakage in 24 hour Pad Weigh Test were 79 g ± 142 and 12,5 g (0-90) respectively. Median ICIQ-UI SF score (Internatiunal Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) decreased from 16 (mean 14,9; range 6-21) to 10 (mean 10,1; range 0-21). The data over the time are presented in table 1. There is no significant degradation of assessed parameters registered from 3 to 12 months follow up. No difference per baseline incontinence severity and Body Mass Index were found. No significant change on Qmax (from 20,6 to 23,9 ml/s) and Post-Void Residual volume (from 5 to 13,7 ml) were reported.  Main post operative adverse events were perineal pain (13; 11%), scrotal pain (10; 8,5%), groin pain (10; 8,5%), 10 (8,5%) of whom required medical treatment, genital paresthesia (7; 5,9%), transient urinary retention (8; 6,8%), urgency (12; 10,2%) and hematoma (4; 3,4%).
Interpretation of results
The Virtue quadratic male sling is a safe and efficacious treatment for urinary incontinence after radical prostatectomy. Primary results showed no difference according to incontinence severity and BMI.
Concluding message
These data should be confirmed in the 3-year follow-up.
Figure 1
Figure 2
References
  1. Comiter C, Rhee Y, Tu LM, Herschorn S and Nitti V. The Virtue sling – A new quadratic sling for postprostatectomy incontinence – results of a multinational Clinical Trial Urology. 2014 Aug;84(2):433-9.
Disclosures
Funding Coloplast Clinical Trial Yes Registration Number ClinicalTrials.gov NCT01608789 RCT No Subjects Human Ethics Committee Hospital Universitario Puerta del mar Ethical committee, Cadiz on 27/09/2013 Helsinki Yes Informed Consent Yes