Med: Urinary Incontinence (Stress, Urge, Mixed)NCT03085979
Mixed Urinary Incontinence Surgical Trial
A study testing Burch Colposuspension, trans obturator tape and tension free vaginal tape in people with Med: Urinary Incontinence (Stress, Urge, Mixed), run by Ain Shams Maternity Hospital.
Trial summary
Surgical management of mixed urinary incontinence Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Med: Urinary Incontinence (Stress, Urge, Mixed)
- What is being tested?
- Burch Colposuspension, trans obturator tape and tension free vaginal tape
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to May 2022
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients with Mixed urinary incontinence
Who cannot join
- Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study. Women who improved on medical treatment with persistence of stress element only were also excluded.
About this study
Official title: Surgical Management of Mixed Urinary Incontinence
Surgical management of mixed urinary incontinence
Read the detailed description
Study to evaluate role of anti-incontinent surgery Burch colposuspension Tension free vaginal tape Trans obturator tape for the management of mixed urinary incontinence .
- Being tested
- Burch Colposuspension, trans obturator tape, tension free vaginal tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Burch ColposuspensionProcedure or surgery
Anti-incontinent surgery
trans obturator tapeProcedure or surgery
Anti-incontinent surgery
tension free vaginal tapeProcedure or surgery
Anti-incontinent surgery
| Study group | Role | What they receive |
|---|---|---|
| Burch | Experimental | Burch Colposuspension Receives: Procedure: Burch Colposuspension |
| Trans Obturator Tape | Experimental | Trans Obturator Tape sling Receives: Procedure: trans obturator tape |
| Tension free vaginal tape | Experimental | Tension free vaginal tape sling Receives: Procedure: tension free vaginal tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure of Mixed incontinence
compare the 3 groups as regard cure rate of both Components of mixed incontinence
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study startOct 2014
- Primary completionOct 2018
- Study completionMay 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Med: Urinary Incontinence (Stress, Urge, Mixed)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamdy Ahmed Saaid, Ain Shams Maternity Hospital
- Investigators
- Hamdy HA Ahmed Saaid, M.D, Principal investigator, Fellow of OBS/GYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085979
- Sponsor's protocol ID
- MUIT
- Status last verified
- Jul 2022
- First submitted
- 10 Mar 2017
- Last updated
- 27 Jul 2022
- 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Management of Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT03085979
- Acronym / sponsor ID
- MUIT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 22 Mar 2017 (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.
Surgical management of mixed urinary incontinence
Detailed description
Study to evaluate role of anti-incontinent surgery Burch colposuspension Tension free vaginal tape Trans obturator tape for the management of mixed urinary incontinence .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Burch | Experimental | Procedure: Burch ColposuspensionBurch Colposuspension |
| Trans Obturator Tape | Experimental | Procedure: trans obturator tapeTrans Obturator Tape sling |
| Tension free vaginal tape | Experimental | Procedure: tension free vaginal tapeTension free vaginal tape sling |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with Mixed urinary incontinence
Key exclusion criteria (1 listed)
- Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study. Women who improved on medical treatment with persistence of stress element only were also excluded.
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 |
|---|---|---|
| Burch ColposuspensionAnti-incontinent surgery | Procedure or surgery | Burch |
| trans obturator tapeAnti-incontinent surgery | Procedure or surgery | Trans Obturator Tape |
| tension free vaginal tapeAnti-incontinent surgery | Procedure or surgery | Tension free vaginal tape |
Primary outcome
cure of Mixed incontinence
Time frame: 1 year
compare the 3 groups as regard cure rate of both Components of mixed incontinence
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 27 Jul 2022.
- Individual participant dataSharing planned: No
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.
Hamdy HA Ahmed Saaid, M.D principal investigator
Fellow of OBS/GYN
Questions about this trial
What is this clinical trial studying?
A study testing Burch Colposuspension, trans obturator tape and tension free vaginal tape in people with Med: Urinary Incontinence (Stress, Urge, Mixed), run by Ain Shams Maternity Hospital.
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 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
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 of Mixed incontinence (time frame: 1 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 27 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.