Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence, Prospective Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- Al-Azhar University
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Complete cure OR improvement of SUI
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified.
Detailed Description
Stress urinary incontinence (SUI) is defined as involuntary passage of urine with rising intra-abdominal pressure. SUI is a common problem affecting 18-26.4% of women. Over the last two decades, SUI treatment has shifted to a mid-urethral sling (MUS) or a mesh-based bladder neck procedure. Although the surgery was believed to be relatively safe, there has been a steep rise in the number of reported cases of their erosion into the lower urinary tract. Several options outside of synthetic mid-urethral sling placement exist, such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection. Each has its limitations, whether related to morbidity or efficacy. The autologous slings most commonly used are the fascia lata and the rectus fascia, and they are placed at the urethra-vesical junction through the 'retropubic' approach. In an attempt to present the benefits of a "transobturator" surgical approach and avoiding risks associated with synthetic sling material, Linder and Elliott, 6performed a novel technique for autologous urethral sling placement via a" trans obturator" approach for managing female SUI. Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases. Notably, no patients had post-operative voiding dysfunction that necessitated sling release, and there were no major (Clavien III-V) complications.The aim of this study is to report long-term transobturator sling outcomes using autologous rectus fascia for SUI in women.
Investigators
Mohamed Fawzy Abd Elfattah Salman
Director
Al-Azhar University
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)
Outcomes
Primary Outcomes
Complete cure OR improvement of SUI
Time Frame: one year
Complete cure means no leak on cough stress test and the patient in satisfied on "patient reported outcome". Improvement means patient reported leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there was no stress urinary incontinence. Failure is considered when patients not fulfilling these criteria
Secondary Outcomes
- Estimated blood loss(24 hours)
- Operative time(2 hours)
- Complications of Autologous TOT(one year)