Female Stress IncontinenceNCT05448482
Hybrid Versus Synthetic TOT for Treatment of SUI
A study testing Transobturator tape in people with Female Stress Incontinence, run by Alexandria University at 1 site in Egypt.
Trial summary
This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Female Stress Incontinence
- What is being tested?
- Transobturator tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2021to 15 Jan 2023
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically proven SUI or stress-predominant mixed urinary incontinence by cough stress test.
Who cannot join
- • Patients with neurogenic voiding dysfunction.
- History of anti-incontinence surgery.
- Presence of urge-predominant mixed urinary incontinence.
- Peripheral neuropathy.
- Multiple sclerosis.
- History of urogenital cancer.
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- Pelvic irradiation
- Body mass index more than 40 kg/m2
- The presence of more than stage 2 pelvic organ prolapse as per pelvic organ prolapse quantification (POP-Q) system score.
- Active urinary tract infection
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria Faculty of Medicine
Alexandria
Amira A. Eid, PHD, amira.eid@alexmed.edu.eg
About this study
Official title: Hybrid Versus Synthetic Transobturator Tape for Treatment of Female Stress Urinary Incontinence: Prospective Randomised Study
This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1 POP are excluded. Patients are randomized into 2 groups, one group will be subjected to h_TOT, and the second group to conventional TOT. Patients are subjected to PGI and UDI-6 questionnaires and a urodynamic study before and 6 months after the both surgery. Success is defined as: no subjective complaint of SUI, negative cough stress test and no leakage on UDS.
Read the detailed description
The present study will be a single center randomized clinical trial. Recruitment will be performed among women presented to Alexandria Main University Hospital urology clinic complaining of urinary stress incontinence, in whom surgery was regarded as the treatment of choice.
Women will be eligible if they have a positive stress test. The stress test will be performed in a semi lithotomy position with a semi full bladder. Women will be randomized into the groups by using Sealed Opaque Envelope System. Patients will be randomized into 2 groups of 25 patient each. One group will be subjected to hybrid TOT, and the second to conventional TOT.
Preoperative and post-operative (at 3 and 6 months) will include:
- Clinical examination including cough stress test.
- Patient global impression questionnaire (PGI)
- Patient questionnaire for incontinence (UDI-6)
- Urodynamic (pressure-flow study)
No concomitant surgery will be performed on women enrolled in the trial. All patients will give a written informed consent.
Technique of hybrid TOT The procedure will be performed while the patient is in dorsal lithotomy position under spinal saddle anesthesia.
A sterile 14 Fr. Foley catheter will be placed per urethra to empty the bladder. The next step will be to harvest a strip of rectus fascia. A 4-5 cm transverse abdominal incision will be made 2 cm cephalad to the pubic symphysis. Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection and the anterior rectus fascia defect will be reapproximated using 1-0 Prolene suture. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested.
Then, normal saline will be injected in the space between the anterior vaginal wall and mid urethra for hydrodissection, followed by a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally.
Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar (C-shaped, specially built for the TOT) will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. The same process will be repeated on the other side. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra. An artery forceps will be kept between the fascia and the urethra to avoid excessive tension. Excess mesh on each side will be removed.
The sling will be secured to the peri-urethral tissue with interrupted polyglactin 4-0 suture to prevent rolling and to ensure a flat, broad based sling. The stab incisions will be closed. The anterior vaginal wall will be closed with polyglactin 4-0 suture. Vagina will be packed with povidone iodine-soaked gauze. Vaginal pack and urethral catheter will be removed in the morning of the first postoperative day.
The 2 groups will be compared using the standard statistical methods regarding outcomes and complications. The primary outcome of the study will be achievement of continence (efficacy) while the secondary outcomes will include intraoperative and early post-operative complications, convalescence, and quality of life.
- Conditions
- Female Stress Incontinence
- Being tested
- Transobturator tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transobturator tapeProcedure or surgery
Mid urethral sling for treatment of female stress urinary incontinence
| Study group | Role | What they receive |
|---|---|---|
| Hybrid transobturator tape | Experimental | Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested.
Then, a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally.
Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra. Receives: Procedure: Transobturator tape |
| Conventional transobturator tape | Active comparator | The conventional mesh using mid urethral sling through the trans obturator route Receives: Procedure: Transobturator tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dryness
Absence of clinical and urodynamic stress incontinence
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start5 Jan 2021
- Primary completion5 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Stress IncontinenceStudies of the same condition, open and under way.
- More trials run by Alexandria 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448482
- Sponsor's protocol ID
- Serial No : 0202538
- Status last verified
- Mar 2022
- First submitted
- 2 Jul 2022
- Last updated
- 7 Jul 2022
- Results posted
- No
- 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 7 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hybrid Versus Synthetic Transobturator Tape for Treatment of Female Stress Urinary Incontinence: Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT05448482
- Acronym / sponsor ID
- Serial No : 0202538
- Conditions
- Female Stress Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 5 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 7 Jul 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.
This prospective study is conducted on female patients presenting with SUI at Alexandria main university hospital. Patients with neurogenic voiding dysfunction, history of anti-incontinence surgery, urge-predominant MUI, urogenital cancer, pelvic irradiation, body mass index more than 40 kg/m2 and more than stage 1 POP are excluded. Patients are randomized into 2 groups, one group will be subjected to h_TOT, and the second group to conventional TOT. Patients are subjected to PGI and UDI-6 questionnaires and a urodynamic study before and 6 months after the both surgery. Success is defined as: no subjective complaint of SUI, negative cough stress test and no leakage on UDS.
Detailed description
The present study will be a single center randomized clinical trial. Recruitment will be performed among women presented to Alexandria Main University Hospital urology clinic complaining of urinary stress incontinence, in whom surgery was regarded as the treatment of choice.
Women will be eligible if they have a positive stress test. The stress test will be performed in a semi lithotomy position with a semi full bladder. Women will be randomized into the groups by using Sealed Opaque Envelope System. Patients will be randomized into 2 groups of 25 patient each. One group will be subjected to hybrid TOT, and the second to conventional TOT.
Preoperative and post-operative (at 3 and 6 months) will include:
- Clinical examination including cough stress test.
- Patient global impression questionnaire (PGI)
- Patient questionnaire for incontinence (UDI-6)
- Urodynamic (pressure-flow study)
No concomitant surgery will be performed on women enrolled in the trial. All patients will give a written informed consent.
Technique of hybrid TOT The procedure will be performed while the patient is in dorsal lithotomy position under spinal saddle anesthesia.
A sterile 14 Fr. Foley catheter will be placed per urethra to empty the bladder. The next step will be to harvest a strip of rectus fascia. A 4-5 cm transverse abdominal incision will be made 2 cm cephalad to the pubic symphysis. Anterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection and the anterior rectus fascia defect will be reapproximated using 1-0 Prolene suture. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested.
Then, normal saline will be injected in the space between the anterior vaginal wall and mid urethra for hydrodissection, followed by a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally.
Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar (C-shaped, specially built for the TOT) will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. The same process will be repeated on the other side. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra. An artery forceps will be kept between the fascia and the urethra to avoid excessive tension. Excess mesh on each side will be removed.
The sling will be secured to the peri-urethral tissue with interrupted polyglactin 4-0 suture to prevent rolling and to ensure a flat, broad based sling. The stab incisions will be closed. The anterior vaginal wall will be closed with polyglactin 4-0 suture. Vagina will be packed with povidone iodine-soaked gauze. Vaginal pack and urethral catheter will be removed in the morning of the first postoperative day.
The 2 groups will be compared using the standard statistical methods regarding outcomes and complications. The primary outcome of the study will be achievement of continence (efficacy) while the secondary outcomes will include intraoperative and early post-operative complications, convalescence, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid transobturator tape | Experimental | Procedure: Transobturator tapeAnterior rectus fascia will be exposed and an approximately 8-10 cm × 1 cm strip of rectus fascia will be marked out. The sling will be harvested using sharp dissection. Thereafter, a Polyprolene monofilamentous mesh of 15 cm x 1 cm will be sutured to each edge of the rectus fascia sling that had been harvested. Then, a 2-cm midline incision over the anterior vaginal wall at the level of mid-urethra. A combination of blunt and sharp dissection will be carried out to the obturator foramen bilaterally. Next, a stab incision will be made at a point approximately 2.5 cm infero-lateral to the pubic tubercle bilaterally, corresponding to the level of clitoris. A trocar will be passed through each obturator foramen (outside-in) and the edge of the mesh will be retracted through the incision. Next, the retraction of both meshes will continue until the rectus fascia sling remain flushed with the urethra. |
| Conventional transobturator tape | Active comparator | Procedure: Transobturator tapeThe conventional mesh using mid urethral sling through the trans obturator route |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically proven SUI or stress-predominant mixed urinary incontinence by cough stress test.
Key exclusion criteria (11 listed)
- • Patients with neurogenic voiding 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 |
|---|---|---|
| Transobturator tapeMid urethral sling for treatment of female stress urinary incontinence | Procedure or surgery | Conventional transobturator tape, Hybrid transobturator tape |
Primary outcome
Dryness
Time frame: 6 months
Absence of clinical and urodynamic stress incontinence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2022.
- 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.
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 tape in people with Female Stress Incontinence, run by Alexandria University 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 1 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 7 Jul 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammad A. Alkhawalka, MSc (01014341748 ext. 02, mohammad.alkhawalka@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dryness (time frame: 6 months). 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 7 Jul 2022.