ClinicalTrials.gg
CompletedNCT07899450Updated Oct 27, 2026

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

An interventional study of Transobturator Autologous Vaginal Wall Sling and Autologous Rectus Sheath Pubovaginal Slinge in Stress Urinary Incontinence (SUI), sponsored by Mohamed Ehab Saad Fadl. Completed at 1 site in Egypt. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Mohamed Ehab Saad Fadl · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Feb 2025, registered Oct 2026).
Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 39 studies in Urinary Incontinence, Stress with a site in Egypt — 15 open to participants now, 19 under way, none of them phase 3. Urinary Incontinence, Stress · Egypt.

Enrollment
24th of 31
40 · median 60
Started
2025
with 4 others
No phase
23 of 39
11 open now
Registered
39th of 39
by date

Among the 39 studies in Urinary Incontinence, Stress with a site in Egypt, this one is the 24th largest by enrollment of the 31 interventional ones that give a count, is one of 5 that started in 2025, is one of 23 with no phase, and was the 39th registered.

Urinary Incontinence, Stress

653 studies on the registry are indexed under Urinary Incontinence, Stress; 121 are open to participants now.

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Open to participants now

15 of the 39 studies in Urinary Incontinence, Stress with a site in Egypt are open now. Recruiting first, the newest first:

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A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 74 Urinary Incontinence, Stress studies recruiting now, 42 (57%) set no upper age limit and 18 (24%) stop at 75 or younger; 2 take children under 18; 16 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

Study 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.

Read the detailed description

This single-center, prospective, exploratory randomized comparative study enrolled 40 adult women undergoing surgical treatment for stress urinary incontinence at Kafrelsheikh University Hospitals, Egypt. Participants were allocated equally to transobturator autologous vaginal wall sling surgery or autologous rectus sheath pubovaginal sling surgery. The sample size was based on feasibility and the limited preliminary evidence available for the vaginal wall technique.

Eligible participants had stress urinary incontinence with a positive cough stress test or mixed urinary incontinence with a predominant stress component. Exclusion criteria included urgency-predominant mixed urinary incontinence, bleeding disorders, active urinary tract infection, underactive bladder with a large post-void residual urine volume, and previous pelvic irradiation.

Preoperative assessment included medical, urinary, obstetric, and surgical histories; a voiding diary; the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF); pelvic examination; and cough stress testing. Investigations included laboratory testing, urine culture, pelvic ultrasonography, measurement of post-void residual urine volume, and uroflowmetry. Urodynamic testing was performed selectively when clinically indicated.

Allocation was concealed using sequentially numbered, sealed, opaque envelopes. Group assignment was disclosed to the operating surgeon immediately before surgery. Postoperative assessments were performed by clinicians who were not involved in the surgical procedures.

The transobturator vaginal wall sling procedure used an approximately 6 × 2 cm autologous anterior vaginal wall graft, supported by permanent polypropylene suspension sutures passed through the obturator route. The rectus sheath pubovaginal sling procedure used an autologous rectus fascial strip harvested through a lower abdominal incision and positioned at the bladder neck or proximal urethra through a retropubic approach. Intraoperative cystoscopy was performed in both groups to check for bladder or urethral injury.

Postoperative follow-up visits were scheduled at 1, 2, 4, and 12 weeks and at six months. Assessments included urinary symptoms, cough stress testing, bladder emptying, wound healing, pain, urgency, and voiding dysfunction. The six-month assessment also included the ICIQ-UI SF and uroflowmetry. Postoperative complications were classified using the Clavien-Dindo system.

The primary outcome was objective continence at six months, defined as the absence of visible urine leakage during a standardized cough stress test. Secondary assessments included urinary symptom scores, operative time, postoperative complications, and urinary functional outcomes.

03

Conditions studied

  • Stress Urinary Incontinence (SUI)

Keywords

  • Female Stress Urinary Incontinence
  • Transobturator Vaginal Wall Sling
  • Autologous Sling
  • Pubovaginal Sling
  • Rectus Sheath Sling
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult female patients with stress urinary incontinence and a positive cough stress test.
  • Patients with mixed urinary incontinence were eligible if the stress component was predominant.

Exclusion criteria

Exclusion Criteria:

  • Mixed urinary incontinence with a predominant urgency component.
  • Bleeding disorders.
  • Active urinary tract infection.
  • Underactive bladder with a large post-void residual urine volume.
  • History of pelvic irradiation.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Transobturator Vaginal Wall Sling

    Participants underwent transobturator autologous vaginal wall sling surgery

    Procedure: Transobturator Autologous Vaginal Wall Sling

  • Active comparator
    Rectus Sheath Pubovaginal Sling

    Participants underwent autologous rectus sheath pubovaginal sling surgery.

    Procedure: Autologous Rectus Sheath Pubovaginal Slinge

Interventions

  • ProcedureTransobturator 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.

  • ProcedureAutologous 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months after surgery

Secondary outcomes

  1. Change in ICIQ-UI Short Form Score

    Change from baseline in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) total score. Scores range from 0 to 21, with higher scores indicating greater urinary incontinence severity and impact. A decrease indicates improvement.

    Time frame: Baseline and 6 months after surgery

  2. Operative Time

    Duration of the surgical procedure, measured in minutes.

    Time frame: During surgery

  3. Percentage of Participants With Postoperative Complications

    Percentage of participants experiencing postoperative complications, with complications classified according to the Clavien-Dindo classification.

    Time frame: From surgery through 6 months after surgery

07

Study locations

1 site
  • Kafrelsheikh University Hospitals
    Kafr ash Shaykh, 33513, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol

Time frame: Beginning 6 months after publication of the study results and continuing for 3 years thereafter.

Access criteria: Qualified researchers may request access to de-identified individual participant data underlying the published results, the study protocol, and a data dictionary by contacting the principal investigator using the email listed in the study record. Requests must include a scientifically sound research proposal and analysis plan. Access will be granted following review by the study team, subject to applicable institutional and ethics requirements and a signed data use agreement. Approved files will be provided through a secure electronic transfer.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2025 to primary completion in Feb 2026, 12 months.

Of 226 non-industry interventional studies with no phase under Urinary Incontinence, Stress, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 12 months is below that.

Counting every sponsor, half of 267 studies reached it within 19 months; a quarter within 9 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Oct 27, 2026
StartActual
Feb 8, 2025
Primary completionActual
Feb 13, 2026
CompletionActual
Feb 20, 2026
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07899450
Lead sponsor
Mohamed Ehab Saad Fadl
Responsible party
Mohamed Ehab Saad Fadl (Demonstrator, Department of urology, Kafrelsheikh University) — Sponsor-investigator
First posted
Oct 27, 2026
Start date
Feb 8, 2025
Primary completion
Feb 13, 2026
Completion
Feb 20, 2026
Last update
Oct 27, 2026

Study contacts

mohamed E Saad Fadl
principal investigator · Department of Urology, Faculty of Medicine, Kafrelsheikh University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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