Comparing two surgical methods for treating stress urinary incontinence
Comparison of Efficacy and Side Effects Between the Obtryx and Solyx Band With 5-year Follow-up. Prospective, Randomized and Non-inferiority Study
This study is testing two different surgical methods to see which one works better for people with stress urinary incontinence and has fewer side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 166 (estimated) |
| Ages | 40 Years and up |
| Sex | Female |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Locations | 1 site (Valencia) |
| Trial ID | NCT03916471 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized, non-inferiority study designed to evaluate the efficacy and side effects of the Solyx™ Single Incision Sling System compared to the Obtryx™ II Sling System in patients suffering from stress urinary incontinence. Participants will undergo a surgical procedure involving a minimal incision for mesh insertion, and their outcomes will be assessed over a five-year follow-up period. The study aims to compare both objective and subjective continence rates, patient satisfaction, and complications associated with each technique.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 40 and older diagnosed with symptomatic stress urinary incontinence who are eligible for stress-free band procedures.
Not a fit: Patients who are pregnant, have a body mass index over 35, or have had previous surgical interventions for incontinence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a more effective and safer surgical option for treating stress urinary incontinence.
How similar studies have performed: Other studies have shown success with similar surgical approaches, but this specific comparison is novel in its long-term follow-up and focus on patient satisfaction.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients diagnosed with symptomatic stress urinary incontinence candidates for stress-free bands * Age \> or = 40 years * informed consent signed by the patient Exclusion Criteria: * patients who are pregnant or wish to become * patients who need anticoagulant * active vaginal or urinary infection * previous surgical interventions for the treatment of incontinence * body mass index \> 35
Where this trial is running
Valencia
- Hospital Universitario y Politécnico La Fe — Valencia, Spain (Recruiting)
Study contacts
- Principal investigator: Marta Garcia — Instituto de Investigación y Politécnico La Fe
- Study coordinator: Maria Cortell
- Email: investigacion_clinica@iislafe.es
- Phone: 0034961246711
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.