Autologous Transobturator Fascia Lata Sling in Treatment of Female Stress Urinary Incontinence
NCT ID: NCT05646745
Last Updated: 2024-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2022-01-01
2026-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence
NCT05647070
Midurethral Sling With Autologus Rectus Sheath
NCT03463863
Female Sling Procedure
NCT04571346
Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence
NCT03296748
Transobturator Urethral Sling Placement With an Autologous Rectus Facia
NCT03949348
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Autologous Fascia lata TOT
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.
Autologous Transobturator Fascia Lata Sling
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Autologous Transobturator Fascia Lata Sling
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Mixed urinary incontinence with predominant stress element.
* Refractory cases to conservative therapy or patients who are not willing to consider (further) conservative treatment.
Exclusion Criteria
* 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.
* 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.
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Al-Azhar University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohamed Fawzy Abd Elfattah Salman
Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mohamed Fawzy Salman
Cairo, , Egypt
Urology department - AlAzhar university
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Fascia Lata TOT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.