Stress Urinary Incontinence (SUI)VIGI-ISTOPNCT06665698
Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment
An observational study of Stress Urinary Incontinence (SUI), run by DILO Medical.
Trial summary
Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2024to Dec 2034
- How long will I take part?
- 10 Years
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population is made up of patients with SUI who should benefit from the implantation of an I-STOP® implant in one of the centers associated with the project.
Who may be able to join
- Adult woman aged over 18 ;
- Patient with SUI, having escaped "conservative" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;
- Patient affiliated to a social security scheme;
- Patient capable of completing a self-questionnaire;
- Patient able to understand the protocol and follow the visit schedule;
- Patient having signed informed consent.
Who cannot join
- Minor patient, pregnant or breastfeeding ;
- Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;
- Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;
- Patient with a medical contraindication to surgery and/or anaesthesia.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women
Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence
Read the detailed description
This is a prospective, multicenter, non-comparative, interventional post-marketing clinical follow-up study (PMCF) on a population of patients with SUI requiring surgical treatment with implantation of an I-STOP sling to document safety, the performance and effectiveness in the short, medium, and long term of these I-STOP® implants used in their intended purpose.
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- I-STOP, MUS, Sling
- Medical subject headings
- Urinary Incontinence, Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reintervention
Questionnaire sent every year to the patient with question about revision surgery: yes / no
Measured: One year after surgery and after each year during 10 years
Secondary outcomes (1)
Quality of Life
Questionnaire sent every year: Pelvic Floor Impact Questionnaire-short form 7 (PFIQ-7)
Measured: One year after surgery and after each year during 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- DILO Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665698
- Sponsor's protocol ID
- VI-IS-24
- Acronym
- VIGI-ISTOP
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 30 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women
- ClinicalTrials.gov ID
- NCT06665698
- Acronym / sponsor ID
- VIGI-ISTOP / VI-IS-24
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- I-STOP, MUS, Sling
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- DILO MedicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2034 (estimated)
- First posted
- 30 Oct 2024 (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.
Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence
Detailed description
This is a prospective, multicenter, non-comparative, interventional post-marketing clinical follow-up study (PMCF) on a population of patients with SUI requiring surgical treatment with implantation of an I-STOP sling to document safety, the performance and effectiveness in the short, medium, and long term of these I-STOP® implants used in their intended purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is made up of patients with SUI who should benefit from the implantation of an I-STOP® implant in one of the centers associated with the project.
Key inclusion criteria (6 listed)
- Adult woman aged over 18 ;
- Patient with SUI, having escaped "conservative" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;
- Patient affiliated to a social security scheme;
- Patient capable of completing a self-questionnaire;
- Patient able to understand the protocol and follow the visit schedule;
Key exclusion criteria (4 listed)
- Minor patient, pregnant or breastfeeding ;
- Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;
- Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;
- Patient with a medical contraindication to surgery and/or anaesthesia.
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
Rate of reintervention
Time frame: One year after surgery and after each year during 10 years
Questionnaire sent every year to the patient with question about revision surgery: yes / no
1 secondary outcome
Quality of Life
Time frame: One year after surgery and after each year during 10 years
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 30 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence (SUI), run by DILO Medical.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Vincent Goria (+33478425845, contact@dilomedical.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reintervention (time frame: One year after surgery and after each year during 10 years). 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 30 Oct 2024.