Stress Urinary IncontinenceNCT05647070
Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence
A study testing Autologous rectus Fascia TOT in people with Stress Urinary Incontinence, run by Al-Azhar University at 2 sites in Egypt.
Trial summary
Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified. 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 rectus Fascia TOT
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2021to 1 Jan 2025
- 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
- Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment.
- Mixed incontinence with predominant Urge urinary incontinence.
- Associated local abnormalities (e.g. cystocele).
- Recent or active urinary tract infection.
- Recent pelvic surgery.
- Neurogenic lower urinary tract dysfunction.
Show all 12Show fewer
- Previous surgery for stress urinary incontinence.
- Pregnancy
- Less than 12 months post-partum.
- Other gynaecologic pathologies affecting bladder functions ( eg,large fibroids)
- 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, +201111788996, prof_mohamed_fawzy@yahoo.com
About this study
Official title: Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence, Prospective Trial
Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified.
Read the detailed description
Stress urinary incontinence (SUI) is defined as involuntary passage of urine with rising intra-abdominal pressure. SUI is a common problem affecting 18-26.4% of women.
Over the last two decades, SUI treatment has shifted to a mid-urethral sling (MUS) or a mesh-based bladder neck procedure. Although the surgery was believed to be relatively safe, there has been a steep rise in the number of reported cases of their erosion into the lower urinary tract. Several options outside of synthetic mid-urethral sling placement exist, such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection. Each has its limitations, whether related to morbidity or efficacy.
The autologous slings most commonly used are the fascia lata and the rectus fascia, and they are placed at the urethra-vesical junction through the 'retropubic' approach. In an attempt to present the benefits of a "transobturator" surgical approach and avoiding risks associated with synthetic sling material, Linder and Elliott, 6performed a novel technique for autologous urethral sling placement via a" trans obturator" approach for managing female SUI.
Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases. Notably, no patients had post-operative voiding dysfunction that necessitated sling release, and there were no major (Clavien III-V) complications.The aim of this study is to report long-term transobturator sling outcomes using autologous rectus fascia for SUI in women.
- Conditions
- Stress Urinary Incontinence
- Being tested
- Autologous rectus Fascia TOT
- 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 rectus Fascia TOTProcedure or surgery
A sterile 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 Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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
| Study group | Role | What they receive |
|---|---|---|
| Autologous rectus Fascia TOT | Experimental | A sterile 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 Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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 Receives: Procedure: Autologous rectus Fascia TOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cure OR improvement of SUI
Complete cure means no leak on cough stress test and the patient in satisfied on "patient reported outcome".
Improvement means patient reported leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there was no stress urinary incontinence.
Failure is considered when patients not fulfilling these criteria
Measured: one year
Secondary outcomes (3)
Complications of Autologous TOT
Measured by clavien-Dindo scoring system
Measured: one year
Estimated blood loss
Blood loss will be estimated by counting up the gauzes and towels used during the procedure [fully soaked gauze = 50 ml blood loss; half-soaked gauze = 30 ml blood loss; fully soaked towel = 150 ml blood loss; half-soaked towel = 75 ml blood loss] (Shorn, 2009).
Measured: 24 hours
Operative time
time consumption from induction of anesthesia till closure of vaginal mucosa
Measured: 2 hours
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 Dec 2021
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- A sterile 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 Pfannestiel incision, \~1 cm× \~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT05647070
- Sponsor's protocol ID
- autologous transobturator tape
- Status last verified
- Aug 2024
- First submitted
- 15 Nov 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Long-term Outcomes of Autologous Transobturator Rectus Fascia Sling for Treatment of Female Stress Urinary Incontinence, Prospective Trial
- ClinicalTrials.gov ID
- NCT05647070
- Acronym / sponsor ID
- autologous transobturator tape
- Conditions
- Stress Urinary Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Jan 2025 (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.
Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases, so long-term outcomes needs to be verified.
Detailed description
Stress urinary incontinence (SUI) is defined as involuntary passage of urine with rising intra-abdominal pressure. SUI is a common problem affecting 18-26.4% of women.
Over the last two decades, SUI treatment has shifted to a mid-urethral sling (MUS) or a mesh-based bladder neck procedure. Although the surgery was believed to be relatively safe, there has been a steep rise in the number of reported cases of their erosion into the lower urinary tract. Several options outside of synthetic mid-urethral sling placement exist, such as the autologous pubovaginal sling, biologic grafts, or urethral bulking agent injection. Each has its limitations, whether related to morbidity or efficacy.
The autologous slings most commonly used are the fascia lata and the rectus fascia, and they are placed at the urethra-vesical junction through the 'retropubic' approach. In an attempt to present the benefits of a "transobturator" surgical approach and avoiding risks associated with synthetic sling material, Linder and Elliott, 6performed a novel technique for autologous urethral sling placement via a" trans obturator" approach for managing female SUI.
Autologous transobturator sling placement is associated with excellent short-term results and can be performed on an outpatient basis in most cases. Notably, no patients had post-operative voiding dysfunction that necessitated sling release, and there were no major (Clavien III-V) complications.The aim of this study is to report long-term transobturator sling outcomes using autologous rectus fascia for SUI in women.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A sterile 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 Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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
| Arm | Type | Receives |
|---|---|---|
| Autologous rectus Fascia TOT | Experimental | Procedure: Autologous rectus Fascia TOTA sterile 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 Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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 |
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 (12 listed)
- Mild Stress urinary incontinence with improvement on conservative therapy or patients refusing surgical treatment.
- Mixed incontinence with predominant Urge urinary incontinence.
- Associated local abnormalities (e.g. cystocele).
- Recent or active urinary tract infection.
- Recent pelvic surgery.
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 rectus Fascia TOTA sterile 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 Pfannestiel incision, ~1 cm× ~5 cm rectus fascia strip is isolated from the anterior rectus sheath. Two stay sutures are secured to the corner of the fascial segment 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 | Procedure or surgery | Autologous rectus Fascia TOT |
Primary outcome
Complete cure OR improvement of SUI
Time frame: one year
Complete cure means no leak on cough stress test and the patient in satisfied on "patient reported outcome". Improvement means patient reported leakage only with severe exertion and using a smaller number of pads per day and she feels that she has improved. On examination there was no stress urinary incontinence. Failure is considered when patients not fulfilling these criteria
3 secondary outcomes
Complications of Autologous TOT
Time frame: one year
Estimated blood loss
Time frame: 24 hours
Operative time
Time frame: 2 hours
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.
- 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 rectus Fascia TOT 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 12 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete cure OR improvement of SUI (time frame: one year). 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 15 Aug 2024.