Effectiveness and safety of shorter tapes for urinary incontinence
The FAST- Study: The Follow-up After Shorter Tapes Study Effectiveness and Safety of Shorter Trans-obturator Tapes: A Prospective Observational Study From the Norwegian Female Incontinence Registry
This study looks at whether shorter surgical tapes for treating urinary incontinence in women can improve their quality of life and have fewer complications compared to longer tapes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 25 Years to 90 Years |
| Sex | Female |
| Sponsor | University Hospital, Akershus Academic / other |
| Locations | 1 site (Lorenskog) |
| Trial ID | NCT06731985 on ClinicalTrials.gov |
What this trial studies
This study evaluates the long-term effectiveness and safety of shorter trans-obturator tapes used in the surgical treatment of stress urinary incontinence (SUI) in women. It focuses on women who underwent surgery with specific tape types between 2009 and 2020, aiming to assess the quality of life improvements and potential complications associated with these shorter slings. The research is observational, meaning it will analyze existing patient data rather than involve new interventions. The goal is to determine if shorter tapes can provide similar benefits to traditional methods while reducing the risk of severe complications.
Who should consider this trial
Good fit: Ideal candidates are women who have undergone surgery for stress urinary incontinence using specific tape types at Akershus University Hospital.
Not a fit: Patients who have had other types of incontinence surgeries or slings will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical options for women suffering from urinary incontinence with fewer complications.
How similar studies have performed: While traditional methods have been well-studied, the specific approach of using shorter tapes is less explored, making this study somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All women operated for stress-urinary incontinence with TVT-O Abbrevo of Ajust incontinence sling between 2009 and 2020. Exclusion Criteria: * Women operated with other incontinence operations or slings.
Where this trial is running
Lorenskog
- Akershus University Hospital — Lorenskog, Norway (Recruiting)
Study contacts
- Principal investigator: Anna Marie Ellstrom Engh Professor, PhD — Akershus university hospital HC
- Study coordinator: Kjersti Rimstad Rimstad, Cand.Med.
- Email: kjerstri@uio.no
- Phone: +4748159564
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.