Stress Urinary IncontinencePhase 3NCT03473041
Autologous Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal
A Phase 3 study testing Hybrid sling and TVT-O in people with Stress Urinary Incontinence, run by sarah mohamed hassan at 1 site in Egypt.
Trial summary
a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O) Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- Hybrid sling and TVT-O
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2018to Sep 2019
- Phase
- Phase 3
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- stress urinary incontinence
Who cannot join
- previous surgery for stress incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence
a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)
Read the detailed description
a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling
- Conditions
- Stress Urinary Incontinence
- Being tested
- Hybrid sling, TVT-O
- Keywords
- female stress incontinence, Transobturator tension free vaginal tape TVTO
- 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.
Hybrid slingProcedure or surgery
sling formed of surgeon tailored autologous rectus sheath and polypropylene arms
TVT-OProcedure or surgery
midurethral transobturator vaginal tape
| Study group | Role | What they receive |
|---|---|---|
| Hybrid sling | Active comparator | 70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling Receives: Procedure: Hybrid sling |
| TVT-O | Active comparator | 70 patients with stress urinary incontinence treated with conventional TVT-O Receives: Procedure: TVT-O |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate
negative cough stress test
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study startMar 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- sarah mohamed hassan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03473041
- Sponsor's protocol ID
- 783
- Status last verified
- Mar 2018
- First submitted
- 15 Mar 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgeon Tailored Hybrid Autologus Rectus Sheath Fascia Versus Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03473041
- Acronym / sponsor ID
- 783
- Conditions
- Stress Urinary Incontinence
- Keywords
- female stress incontinence, Transobturator tension free vaginal tape TVTO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- sarah mohamed hassanUniversity, hospital or other
- Study start
- Mar 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 21 Mar 2018 (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.
a hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) versus transobturator tension free vaginal tape(TVT-O)
Detailed description
a surgeon tailored hybrid sling formed of a central part of autologus rectus sheath (2×6 cm) and two arms of polypropylene mesh (2×10cm) is used for treatment of urinary stree incontinence and its efficacy is compared to transobturator tension free vaginal tape (TVT-O) conventional mid urethral sling
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid sling | Active comparator | Procedure: Hybrid sling70 patients with stress urinary incontinence treated with surgeon tailored hybrid sling |
| TVT-O | Active comparator | Procedure: TVT-O70 patients with stress urinary incontinence treated with conventional TVT-O |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- stress urinary incontinence
Key exclusion criteria (1 listed)
- previous surgery for stress incontinence
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 |
|---|---|---|
| Hybrid slingsling formed of surgeon tailored autologous rectus sheath and polypropylene arms | Procedure or surgery | Hybrid sling |
| TVT-Omidurethral transobturator vaginal tape | Procedure or surgery | TVT-O |
Primary outcome
cure rate
Time frame: 1 year follow up
negative cough stress test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hybrid sling and TVT-O in people with Stress Urinary Incontinence, run by sarah mohamed hassan 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 1 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 21 Mar 2018. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
cure rate (time frame: 1 year follow up). 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 21 Mar 2018.