Stress Urinary Incontinence (SUI)NCT07899450
Comparison of Two Autologous Sling Procedures for Stress Urinary Incontinence in Women
A study testing Transobturator Autologous Vaginal Wall Sling and Autologous Rectus Sheath Pubovaginal Slinge in people with Stress Urinary Incontinence (SUI), run by Mohamed Ehab Saad Fadl at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- Transobturator Autologous Vaginal Wall Sling and Autologous Rectus Sheath Pubovaginal Slinge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Feb 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- Transobturator Autologous Vaginal Wall Sling, Autologous Rectus Sheath Pubovaginal Slinge
- Keywords
- Female Stress Urinary Incontinence, Transobturator Vaginal Wall Sling, Autologous Sling, Pubovaginal Sling, Rectus Sheath Sling
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transobturator Autologous Vaginal Wall SlingProcedure or 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.
Autologous Rectus Sheath Pubovaginal SlingeProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Transobturator Vaginal Wall Sling | Experimental | Participants underwent transobturator autologous vaginal wall sling surgery Receives: Procedure: Transobturator Autologous Vaginal Wall Sling |
| Rectus Sheath Pubovaginal Sling | Active comparator | Participants underwent autologous rectus sheath pubovaginal sling surgery. Receives: Procedure: Autologous Rectus Sheath Pubovaginal Slinge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Secondary outcomes (3)
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.
Measured: Baseline and 6 months after surgery
Operative Time
Duration of the surgical procedure, measured in minutes.
Measured: During surgery
Percentage of Participants With Postoperative Complications
Percentage of participants experiencing postoperative complications, with complications classified according to the Clavien-Dindo classification.
Measured: From surgery through 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start8 Feb 2025
- Primary completion13 Feb 2026
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized study involving 40 women allocated in a 1:1 ratio to transobturator autologous vaginal wall sling surgery (20 participants) or autologous rectus sheath pubovaginal sling surgery (20 participants), with postoperative follow-up for six months.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Ehab Saad Fadl
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ehab Saad Fadl, Kafrelsheikh University
- Investigators
- mohamed E Saad Fadl, Principal investigator, Department of Urology, Faculty of Medicine, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899450
- Sponsor's protocol ID
- KFS-SUI-2025-01
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07899450
- Acronym / sponsor ID
- KFS-SUI-2025-01
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- Female Stress Urinary Incontinence, Transobturator Vaginal Wall Sling, Autologous Sling, Pubovaginal Sling, Rectus Sheath Sling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mohamed Ehab Saad FadlUniversity, hospital or other
- Study start
- 8 Feb 2025 (actual)
- Primary completion
- 13 Feb 2026 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized study involving 40 women allocated in a 1:1 ratio to transobturator autologous vaginal wall sling surgery (20 participants) or autologous rectus sheath pubovaginal sling surgery (20 participants), with postoperative follow-up for six months.
| Arm | Type | Receives |
|---|---|---|
| Transobturator Vaginal Wall Sling | Experimental | Procedure: Transobturator Autologous Vaginal Wall SlingParticipants underwent transobturator autologous vaginal wall sling surgery |
| Rectus Sheath Pubovaginal Sling | Active comparator | Procedure: Autologous Rectus Sheath Pubovaginal SlingeParticipants underwent autologous rectus sheath pubovaginal sling surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transobturator Autologous Vaginal Wall SlingAn 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 or surgery | Transobturator Vaginal Wall Sling |
| Autologous Rectus Sheath Pubovaginal SlingeAn 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. | Procedure or surgery | Rectus Sheath Pubovaginal Sling |
Primary outcome
Percentage of Participants With Objective Cure on Cough Stress Testing
Time frame: 6 months after surgery
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.
3 secondary outcomes
Change in ICIQ-UI Short Form Score
Time frame: Baseline and 6 months after surgery
Operative Time
Time frame: During surgery
Percentage of Participants With Postoperative Complications
Time frame: From surgery through 6 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background publication describing the transobturator vaginal wall sling technique.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed E Saad Fadl principal investigator
Department of Urology, Faculty of Medicine, Kafrelsheikh University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transobturator Autologous Vaginal Wall Sling and Autologous Rectus Sheath Pubovaginal Slinge in people with Stress Urinary Incontinence (SUI), run by Mohamed Ehab Saad Fadl at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Objective Cure on Cough Stress Testing (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.