The Elgamasy Transobturator Vaginal Wall Sling Versus Rectus Sheath Pubovaginal Sling for the Treatment of Female Stress Urinary Incontinence: A Randomized Comparative Study
Sponsor study identifier
interventional
40
1 country
1
Study Start
February 8, 2025
Actual (reported)Primary Completion
February 13, 2026
Actual (reported)Study Completion
February 20, 2026
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 20, 2026
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2025
Actual (reported)February 13, 2026
Actual (reported)February 20, 2026
Actual (reported)October 20, 2026
Actual (reported)October 27, 2026
Actual (reported)Percentage of Participants With Objective Cure on Cough Stress Testing
Objective cure is defined as the absence of visible urine leakage during a standardized cough stress test at the six-month postoperative assessment. Participants with visible urine leakage during the test are classified as treatment failures.
6 months after surgery
Change in ICIQ-UI Short Form Score
Baseline and 6 months after surgery
Operative Time
During surgery
Percentage of Participants With Postoperative Complications
From surgery through 6 months after surgery
Participants underwent transobturator autologous vaginal wall sling surgery
Participants underwent autologous rectus sheath pubovaginal sling surgery.
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.
Kafrelsheikh University Hospitals
Kafr ash Shaykh, 33513, Egypt
mohamed E Saad Fadl
Department of Urology, Faculty of Medicine, Kafrelsheikh University
40 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2026
First Posted
October 27, 2026
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.
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Study Start
February 8, 2025
Actual (reported)Primary Completion
February 13, 2026
Actual (reported)Study Completion
February 20, 2026
Actual (reported)Last Updated
October 27, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the reported study results will be shared, including baseline demographic and clinical characteristics, assigned surgical intervention, cough stress test outcomes, ICIQ-UI Short Form scores, operative time, uroflowmetry measurements, post-void residual urine volume, and postoperative complications. Names, contact details, medical record numbers, and other identifying information will not be shared.
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Source: ClinicalTrials.gov.
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