Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence

Launched by AL-AZHAR UNIVERSITY · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called the autologous transobturator sling, which is designed to help women who suffer from stress urinary incontinence. This condition means that women may accidentally leak urine during activities like laughing, sneezing, or exercising. The sling is made from the patient’s own tissue, and while it has shown good results in the short term, this study aims to understand its long-term effectiveness and outcomes.

To join the trial, women must have genuine stress urinary incontinence or mixed urinary incontinence where stress is the main issue, especially if they haven't found relief from other treatments. However, women with mild incontinence that improves with conservative methods, certain urinary tract issues, or those who are pregnant or recently had a baby may not be eligible. Participants can expect to have the procedure done as an outpatient, meaning they can go home the same day, and they will be monitored over time to see how well the treatment works for them. Overall, this trial will provide valuable information about a promising treatment for women dealing with this challenging condition.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with genuine stress urinary incontinence.
• • Mixed urinary incontinence with predominant stress element.
• • Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.
• Exclusion Criteria:
• • Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment.
• • Mixed incontinence with predominant Urge urinary incontinence.
• • Associated local abnormalities (e.g. cystocele).
• • Recent or active urinary tract infection.
• • Recent pelvic surgery.
• • Neurogenic lower urinary tract dysfunction.
• • Previous surgery for stress urinary incontinence.
• • Pregnancy
• • Less than 12 months post-partum.
• • Other gynaecologic pathologies affecting bladder functions ( eg,large fibroids)
• • Genito-urinary malignancy.
• • Current chemo or radiation therapy.