Urinary Incontinence, StressNCT04098822
A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence
An observational study of Urinary Incontinence, Stress, run by Coloplast A/S at 13 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Virtue male sling
- Type of treatment
- Medical device
- How many people
- 130 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 29 Jun 2017to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patient implanted with Virtue® Male Sling System to treat post-prostatectomy urinary incontience
Who may be able to join
- Implanted with the Virtue® Male Sling System
Who cannot join
- 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
Trial locations and contacts
13 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 2 countries
France12 sites, 6 recruiting
- Recruiting
CHU Angers
Angers, 49933
Thibaut Culty, Dr
Thibaut Culty, Dr
- Recruiting
Jean Minjoz Hospital
Besançon, 25030
François Kleinclauss, Pr
François Kleinclauss, Pr
- Recruiting
CHU de Caen
Caen, 14033
Xavier Tillou, Pr
Xavier Tillou, Pr
- Recruiting
Centre Hospitalier Chalon Sur Saône William Morey
Chalon-sur-Saône, 71321
Nicolas Koutlidis, Dr
Sébastien Bassard, Dr
- Terminated
Groupe Hospitalier Henri Mendor
Créteil, 94010
- Withdrawn
Claude Huriez Hospital
Lille, 59037
- Completed
Clinique Mutualiste de la Porte de l'Orient
Lorient, 56100
- Completed
Edouard Herriot Hospital
Lyon, 69003
- Completed
Clinique de l'Esperance
Mougins, 06250
- Recruiting
CHU Carémeau
Nîmes, 30029
Laurent Wagner, Dr
Laurent Wagner, Dr
- Recruiting
Clinique Urologique Nantes-Atlantis
Saint-Herblain, 44800
Thierry Rousseau, Dr
Thierry Rousseau, Dr
- Withdrawn
Clinique Paul Picquet
Sens, 89000
Italy1 site
- Withdrawn
Ospedale Generale Regionale F. Miull
Acquaviva delle Fonti, 70021
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Virtue male sling
- Keywords
- Urinary Incontinence, Stress, Suburethral Slings, Prostatectomy
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtue male slingDevice
The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from in-trinsic sphincter deficiency (ISD). The sling is manufactured from polypropylene and is sold for single use only. The device is a quadratic sling and consists of a knitted monofilament polypropylene mesh. The body of the device provides surface area for supporting the bulbous urethra.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 12 months
Secondary outcomes (7)
Pad weight testing
Percent change in weight from baseline in 24-hour or 1-hour pad weight test
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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".
Measured: 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
Measured: Baseline, 8 weeks, 12, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start29 Jun 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- René Yiou, Pr, Principal investigator, CHU Henri Mondor, Créteil, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04098822
- Sponsor's protocol ID
- SU018
- Status last verified
- Feb 2023
- First submitted
- 7 Jun 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04098822
- Acronym / sponsor ID
- SU018
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Urinary Incontinence, Stress, Suburethral Slings, Prostatectomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient implanted with Virtue® Male Sling System to treat post-prostatectomy urinary incontience
Key inclusion criteria (1 listed)
- Implanted with the Virtue® Male Sling System
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtue male slingThe Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from in-trinsic sphincter deficiency (ISD). The sling is manufactured from polypropylene and is sold for single use only. The device is a quadratic sling and consists of a knitted monofilament polypropylene mesh. The body of the device provides surface area for supporting the bulbous urethra. | Device | – |
Primary outcome
Patient Global Impression of Improvement (PGI-I)
Time frame: 12 months
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
Adverse events
Time frame: 12 months
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.
7 secondary outcomes
Pad weight testing
Time frame: Baseline, 8 weeks and 12 months
Uroflowmetry
Time frame: Baseline, 8 weeks, 12 months
Post-void residual (PVR) volume
Time frame: Baseline, 8 weeks, 12 months
Pad Use
Time frame: Baseline, 8 weeks, 12, 24, 36 months
International Consultation on Incontinence Questionnaire (ICIQ-UI)
Time frame: Baseline, 8 weeks, 12, 24, 36 months
Subject global satisfaction questionnaire
Time frame: 8 weeks, 12, 24, 36 months
Incontinence quality of life questionnaire (I-QoL)
Time frame: Baseline, 8 weeks, 12, 24, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
René Yiou, Pr principal investigator
CHU Henri Mondor, Créteil, France
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Stress, run by Coloplast A/S at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hugo Ryckebusch, Dr (+33 1 40 83 68 52, frhr@coloplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Global Impression of Improvement (PGI-I) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.