A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence

A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort in Subjects With Male Stress Urinary Incontinence

The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence, Stress
• Intervention / Treatment: Device: Virtue male sling

Detailed Description

This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed annually during 2 additional years.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Recruiting
    • CHU Angers
  • Besançon, France, 25030
    • Recruiting
    • Jean Minjoz Hospital
  • Caen, France, 14033
    • Recruiting
    • CHU de Caen
  • Chalon-sur-Saône, France, 71321
    • Recruiting
    • Centre Hospitalier Chalon Sur Saône William Morey
  • Créteil, France, 94010
    • Terminated
    • Groupe Hospitalier Henri Mendor
  • Lille, France, 59037
    • Withdrawn
    • Claude Huriez Hospital
  • Lorient, France, 56100
    • Completed
    • Clinique Mutualiste de la Porte de l'Orient
  • Lyon, France, 69003
    • Completed
    • Edouard Herriot Hospital
  • Mougins, France, 06250
    • Completed
    • Clinique de l'Esperance
  • Nîmes, France, 30029
    • Recruiting
    • CHU Caremeau
  • Saint-Herblain, France, 44800
    • Recruiting
    • Clinique Urologique Nantes-Atlantis
  • Sens, France, 89000
    • Withdrawn
    • Clinique Paul Picquet
• Italy
  • Acquaviva Delle Fonti, Italy, 70021
    • Withdrawn
    • Ospedale Generale Regionale F. Miull

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patient implanted with Virtue® Male Sling System to treat post-prostatectomy urinary incontience

Description

Inclusion Criteria:

• Implanted with the Virtue® Male Sling System

Exclusion Criteria:

• Refuses to be included in the survey or that their medical data will be used for research purposes.
• Indication for the Virtue® Male Sling System implantation is not for the treatment of male urinary incontinence

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression of Improvement (PGI-I)	PGI-I is a validated questionnaire that collects the patient's impression of improvement after the surgery. Among this 7-point scale (very much better, much better, a little better, no change, a little worse, much worse and very much worse), we ask the patients to check the one number that best decribes how their urinary tract condition is now, compared with how it's was before the surgery. Patients who score little or much or very much better will be considered a treatment success. We measure the percentage of patient who describe the treatment success	12 months
Adverse events	Adverse events are any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity, and frequency. At 12-months, we measure the percentage of patients without any device related severe or serious adverse events.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pad weight testing	Percent change in weight from baseline in 24-hour or 1-hour pad weight test	Baseline, 8 weeks and 12 months
Uroflowmetry	Uroflowmetry including a measure of voided volume and the peak urine flow rate (Qmax) will be collected up to 12-months. Data will be used to determine the presence of urinary obstruction. If the Qmax is considered normal by the physician after the procedure it is not necessary to collect these data at subsequent follow-up visits.	Baseline, 8 weeks, 12 months
Post-void residual (PVR) volume	PVR volume will be collected pre-and post implant procedure up to 12-months. If the PVR volume is considered normal by the physician after the procedure it is not necessary to collect these data at subsequent follow-up visits.	Baseline, 8 weeks, 12 months
Pad Use	The number of pads used per day will be collected. Patients will be considered to be pad free if they report never wearing pads or wear pads just for a sense of security.	Baseline, 8 weeks, 12, 24, 36 months
International Consultation on Incontinence Questionnaire (ICIQ-UI)	The ICIQ-UI Short Form is a self-administred questionnaire to evaluate the frequency, severity, and impact on quality of life of urinary incontinence. Question 1 asked, "How often do you leak urine?" Subjects were instructed to select among "none" (0), "about once a week or less often" (1), "2 or 3 times a week" (2), "about once a day" (3), "several times a day" (4), and "all the time" (5). Question 2 asked, "How much urine do you usually leak (whether you wear protection or not)?" Patients responded with "none" (0), "a small amount" (2), "a moderate amount" (4) or "a large amount (6). Question 3 asked, "Overall, how much does leaking urine interfere with your everyday life?" Participants chose a number from 0 (not at all) to 10 (a great deal). Questions 1, 2 and 3 are summed to compute the total ICIQ SF score. The total score range is then a minimum of 0 to a maximum of 21. The mean score, absolute and relative change compared to baseline will be measure	Baseline, 8 weeks, 12, 24, 36 months
Subject global satisfaction questionnaire	This non-validated questionnaire provides additional information concerning patient satisfaction. The survey consists of two questions: How satisfied are you with your surgery?. Among 5 point-scale (very satisfied, satisfied, not satisfied-not dissatisfied, dissatisfied, very dissatisfied), patient check the one item that best describes the subject satisfaction. We measure the percentage the patients who very satisfied and satisfied. The patient answer the question "Do you recommend this operation to a friend?" by yes or no. We measure the percentage the patients who answer "yes".	8 weeks, 12, 24, 36 months
Incontinence quality of life questionnaire (I-QoL)	The I-QoL is a validated survey questionnaire with 22 items that are scored on a 5-point Likert scale. The I-QOL and its subscale scores are computed by adding each item's response, subtracting the lowest possible score and dividing that sum by the possible raw score range. The scores are then transformed to have a range from 0 (maximum problem) to 100 (no problem at all). The mean score, absolute and relative change compared to baseline	Baseline, 8 weeks, 12, 24, 36 months

Collaborators and Investigators

• Sponsor: Coloplast A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 29, 2017
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: June 7, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Urinary Incontinence, Stress; Prostatectomy; Suburethral Slings
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: SU018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available