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COMPLETED
NCT07899450
NA

Comparison of Two Autologous Sling Procedures for Stress Urinary Incontinence in Women

Sponsor: Mohamed Ehab Saad Fadl

View on ClinicalTrials.gov

Summary

This study compares two operations for stress urinary incontinence in adult women. Stress urinary incontinence means leaking urine during activities such as coughing, sneezing, laughing, or exercising. Women with both stress-related leakage and a sudden urgent need to urinate were also eligible if stress-related leakage was their main problem. Both operations use the woman's own tissue to create a sling that supports the urethra, the tube that carries urine out of the bladder. One operation uses tissue from the vaginal wall, placed through openings in the pelvic bones near the groin (a transobturator vaginal wall sling). The other uses tissue from the strong layer covering the abdominal muscles (a rectus sheath pubovaginal sling). Neither operation uses synthetic mesh, although permanent supporting stitches are used. Forty women at Kafrelsheikh University Hospitals, Egypt, were randomly assigned to one of the two operations, with 20 women in each group. Follow-up continued for six months after surgery. The main question is whether the operations differ in preventing urine leakage during a cough test six months after surgery. The study also compares urinary symptoms, operation duration, urine flow, bladder emptying, and complications.

Official title: The Elgamasy Transobturator Vaginal Wall Sling Versus Rectus Sheath Pubovaginal Sling for the Treatment of Female Stress Urinary Incontinence: A Randomized Comparative Study

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-02-08

Completion Date

2026-02-20

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

PROCEDURE

Transobturator Autologous Vaginal Wall Sling

An approximately 6 × 2 cm graft harvested from the participant's anterior vaginal wall is positioned beneath the midurethra. Permanent polypropylene suspension sutures are passed bilaterally through the obturator foramina using an outside-in approach. The sling is positioned without tension and secured to the periurethral tissues. Intraoperative cystoscopy is performed to exclude bladder or urethral injury.

PROCEDURE

Autologous Rectus Sheath Pubovaginal Slinge

An autologous rectus sheath graft measuring approximately 6-8 cm in length and 1.5-2 cm in width is harvested through a lower abdominal Pfannenstiel incision. The graft is positioned at the bladder neck or proximal urethra, with permanent polypropylene suspension sutures passed through the retropubic space to the suprapubic region. Intraoperative cystoscopy is performed to exclude bladder or urethral injury.

Locations (1)

Kafrelsheikh University Hospitals

Kafr ash Shaykh, Egypt