Stress Urinary IncontinenceNCT05646745
Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
A study testing Autologous Transobturator Fascia Lata Sling in people with Stress Urinary Incontinence, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Autologous Transobturator Fascia Lata Sling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2022to 1 Jan 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Mixed incontinence with predominant Urge urinary incontinence.
- Associated local abnormalities that may affect surgery outcomes (e.g. complete procidentia).
- Recent or active urinary tract infection.
- Recent pelvic surgery.
- Neurogenic lower urinary tract dysfunction.
- Previous surgery for stress urinary incontinence.
Show all 11Show fewer
- Pregnancy
- Less than 12 months post-partum.
- Other gynaecologic pathologies affecting bladder functions ( eg, large fibroids, ovarian cysts)
- Genito-urinary malignancy.
- Current chemo or radiation therapy.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Mohamed Fawzy Salman
Cairo
Mohamed F Salman, MD, +201111788996, prof_mohamed_fawzy@yahoo.com
Aboelfotoh A Aboelfoth, MD
- Recruiting
Urology department - AlAzhar university
Cairo
Mohamed F Salman, MD, +201111788996, Prof_mohamed_fawzy@yahoo.com
Mohamed F Salman, MD
About this study
To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals.
Read the detailed description
Following induction of anesthesia and administration of perioperative antibiotics, the patient is positioned in the dorsal lithotomy position, sterilization and draping will be done. A sterile 16 French Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides.
Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side.
About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Autologous Transobturator Fascia Lata Sling
- Keywords
- Autologous, TOT, SUI, Stress
- 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.
Autologous Transobturator Fascia Lata SlingProcedure or surgery
Hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides.
Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side.
About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Fascia lata TOT | Experimental | Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side.
About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip. Receives: Procedure: Autologous Transobturator Fascia Lata Sling |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete cure
Number of patients without leakage with cough stress test and the patient is satisfied and on examination there is no leakage with cough test.
Measured: 3 months
Secondary outcomes (1)
improvement of SUI
Number of patients who report leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there is no stress urinary incontinence.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start1 Jan 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Autologous fascia lata is utilized via transobturator approach
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fawzy Abd Elfattah Salman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646745
- Sponsor's protocol ID
- Fascia Lata TOT
- Status last verified
- Aug 2024
- First submitted
- 3 Dec 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salman MFA, Hassan AA, Wasfy IS, Deif H, Hassan AA, Hindawy MA, Hassan AMA, Ali MM, Abdel-Al I, Koritenah AK, Abuelazayem TM, Keritna HKM. Autologous Transobturator Fascia Lata Sling for Female Stress Urinary Incontinence: A Pilot Feasibility and Safety Study. Low Urin Tract Symptoms. 2026 Sep;18(5):e70085. doi: 10.1111/luts.70085.
PubMed 42521462
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT05646745
- Acronym / sponsor ID
- Fascia Lata TOT
- Conditions
- Stress Urinary Incontinence
- Keywords
- Autologous, TOT, SUI, Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 12 Dec 2022 (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.
To evaluate the outcome of autologous transobturator fascia lata sling for treatment of female stress urinary incontinence at Al-Azhar university hospitals.
Detailed description
Following induction of anesthesia and administration of perioperative antibiotics, the patient is positioned in the dorsal lithotomy position, sterilization and draping will be done. A sterile 16 French Foley catheter is placed to drain the bladder, following this, injectable normal saline is utilized using 10 cc syringe for hydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides.
Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side.
About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Autologous fascia lata is utilized via transobturator approach
| Arm | Type | Receives |
|---|---|---|
| Autologous Fascia lata TOT | Experimental | Procedure: Autologous Transobturator Fascia Lata SlingThrough incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side. About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- Mixed incontinence with predominant Urge urinary incontinence.
- Associated local abnormalities that may affect surgery outcomes (e.g. complete procidentia).
- Recent or active urinary tract infection.
- Recent pelvic surgery.
- Neurogenic lower urinary tract dysfunction.
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 |
|---|---|---|
| Autologous Transobturator Fascia Lata SlingHydro-distention of the anterior vaginal wall, and a midline incision is made based on the mid-urethra. Dissection is carried out bilaterally to the obturator Foramen on both sides. Through incision in the lower lateral aspect of the thigh, 4 cm above the knee, ~1 cm× ~5 cm fascial strip is isolated from the fascia lata. Two stay sutures are secured to the corners of the fascial segment on each side. About 1cm skin incision is performed at the thigh fold on each side. Next, two separate trocar passages are performed on each side using a reusable C-shaped trocar, with care taken to ensure at least a 1 cm tissue bridge in the obturator membrane between the superior and inferior passes. Following this, the stay sutures are tied external to the obturator membrane on both sides, leaving the sling secured and flush with the mid-urethra. Sutures are also placed to secure the sling to the periurethral tissue to prevent rolling or migration of the fascial strip. | Procedure or surgery | Autologous Fascia lata TOT |
Primary outcome
complete cure
Time frame: 3 months
Number of patients without leakage with cough stress test and the patient is satisfied and on examination there is no leakage with cough test.
1 secondary outcome
improvement of SUI
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Derived from this study: PubMed 42521462Salman MFA, Hassan AA, Wasfy IS, Deif H, Hassan AA, Hindawy MA, Hassan AMA, Ali MM, Abdel-Al I, Koritenah AK, Abuelazayem TM, Keritna HKM. Autologous Transobturator Fascia Lata Sling for Female Stress Urinary Incontinence: A Pilot Feasibility and Safety Study. Low Urin Tract Symptoms. 2026 Sep;18(5):e70085. doi: 10.1111/luts.70085.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Transobturator Fascia Lata Sling in people with Stress Urinary Incontinence, run by Al-Azhar University at 2 sites 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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed F Salman, MD (00201111788996, Prof_mohamed_fawzy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete cure (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05646745, which also lists 1 linked publication.
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 15 Aug 2024.