Urinary IncontinenceNCT02927548
Evaluation of the Efficacy and Safety of Advantage® Strips in Women Stress Urinary Incontinence (SUI )
An observational study of Urinary Incontinence, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
This is a single-center retrospective study that evaluates the effectiveness and long-term safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary incontinence in women on a population of 500 patients with a mean follow-up of 6 years. Read more about this study
- Who is it for?
- Ages 29 to 89 years, women only
- Conditions the study is for
- Urinary Incontinence
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2005to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 29 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: patient of CHU Nîmes
Who may be able to join
- patient who received the laying of a strip ADVANTAGE between 1/1/2015 and 1/6/2012
Who cannot join
- no
Trial locations and contacts
1 site in 1 country.
About this study
This is a single-center retrospective study that evaluates the effectiveness and long-term safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary incontinence in women on a population of 500 patients with a mean follow-up of 6 years.
- Conditions
- Urinary Incontinence
- Medical subject headings
- Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient global improvement scale
Measured: 6 years
Complications
Measured: 6 years
Urinary symptom questionnaire
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2016 (estimated)
- Study startJan 2005
- Primary completionJun 2012
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02927548
- Sponsor's protocol ID
- IRB 15 01 06
- Status last verified
- Sep 2016
- First submitted
- 14 Sep 2016
- Last updated
- 18 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Advantage® Strips in Women Stress Urinary Incontinence (SUI )
- ClinicalTrials.gov ID
- NCT02927548
- Acronym / sponsor ID
- IRB 15 01 06
- Conditions
- Urinary Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 7 Oct 2016 (estimated)
- 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.
This is a single-center retrospective study that evaluates the effectiveness and long-term safety of the TVT tape ( advantage Boston Scientific) in the treatment of stress urinary incontinence in women on a population of 500 patients with a mean follow-up of 6 years.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 29 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient of CHU Nîmes
Key inclusion criteria (1 listed)
- patient who received the laying of a strip ADVANTAGE between 1/1/2015 and 1/6/2012
Key exclusion criteria (1 listed)
- no
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient global improvement scale
Time frame: 6 years
Complications
Time frame: 6 years
Urinary symptom questionnaire
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient global improvement scale (time frame: 6 years). The study lists 3 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 18 Jun 2026.