Stress Urinary IncontinencePhase 3NCT03463863
Midurethral Sling With Autologus Rectus Sheath
A Phase 3 study testing rectus sheath midurethral sling in people with Stress Urinary Incontinence, run by sarah mohamed hassan at 1 site in Egypt.
Trial summary
assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling 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?
- rectus sheath midurethral sling
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2016to Jan 2018
- 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 incontinence
Who cannot join
- overactive bladder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Safety And Efficacy Of Autologus Rectus Sheath Fascia As A Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence.
assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling
Read the detailed description
the rectus sheath is harvested in 5 cm length and 2 cm width , A 2cm width 8 cm length polypropolyine mesh is attached to the harvest rectus sheet sling on both side The procedure is carried with a similar technique to the outside in TOT.
- Conditions
- Stress Urinary Incontinence
- Being tested
- rectus sheath midurethral sling
- 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.
rectus sheath midurethral slingProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate of stress incontinence
history and urodynamic study
Measured: one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start10 Aug 2016
- Primary completionJan 2018
- Study completionJan 2018
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
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
- NCT03463863
- Sponsor's protocol ID
- 732222
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety And Efficacy Of Autologus Rectus Sheath Fascia As A Midurethral Transobturator Tension Free Vaginal Tape For Treatment Of Stress Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT03463863
- Acronym / sponsor ID
- 732222
- Conditions
- Stress Urinary Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- sarah mohamed hassanUniversity, hospital or other
- Study start
- 10 Aug 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 13 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.
assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling
Detailed description
the rectus sheath is harvested in 5 cm length and 2 cm width , A 2cm width 8 cm length polypropolyine mesh is attached to the harvest rectus sheet sling on both side The procedure is carried with a similar technique to the outside in TOT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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 incontinence
Key exclusion criteria (1 listed)
- overactive bladder
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 |
|---|---|---|
| rectus sheath midurethral sling | Procedure or surgery | – |
Primary outcome
cure rate of stress incontinence
Time frame: one year after surgery
history and urodynamic study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
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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 rectus sheath midurethral sling 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: finished, as of the sponsor's last update on 16 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of stress incontinence (time frame: one year after surgery). 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 16 Mar 2018.