Trials / Not Yet Recruiting
Not Yet RecruitingNCT06665698
Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment
Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- DILO Medical · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Timeline
- Start date
- 2024-11-01
- Primary completion
- 2025-12-01
- Completion
- 2034-12-01
- First posted
- 2024-10-30
- Last updated
- 2024-10-30
Source: ClinicalTrials.gov record NCT06665698. Inclusion in this directory is not an endorsement.