Stress Urinary IncontinencePhase 2/3NCT03296748
Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence
A Phase 2/3 study testing trans-obturator tape inside-out usingsoft tapes. and anterior colporraphy in people with Stress Urinary Incontinence, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence Read more about this study
- Who is it for?
- Ages 23 to 56 years, women only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- trans-obturator tape inside-out usingsoft tapes. and anterior colporraphy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2016to Sep 2017
- Phase
- Phase 2/3
- 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 23 to 56 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female patients
- genuine stress incontinence
- asymptomatic cystocele
Who cannot join
- mixed incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?
The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence
Read the detailed description
female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.
- Conditions
- Stress Urinary Incontinence
- Being tested
- trans-obturator tape inside-out usingsoft tapes., anterior colporraphy
- Keywords
- asymptomatic cystocele., stress urinary incontinence
- 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.
trans-obturator tape inside-out usingsoft tapes.Procedure or surgery
Also called anterior colporrhaphy
trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
anterior colporraphyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| TOT only group | Active comparator | 60 patients with stress incontinence and asymptomatic grade 2 cystocele. Receives: Procedure: trans-obturator tape inside-out usingsoft tapes. |
| concomitant repair group | Active comparator | 63 patients with stress incontinence and asymptomatic grade 2 cystocele. Receives: Procedure: trans-obturator tape inside-out usingsoft tapes.; Procedure: anterior colporraphy |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate of stress incontinence
by clinical assessment
Measured: 3 months after surgery
Denovo urgency
by clinical assessment
Measured: 3 months after surgery
Secondary outcomes (4)
cure rate of stress incontinence
by clinical assessment
Measured: 6 months after surgery
cure rate of stress incontinence
by clinical assessment
Measured: 12 months after surgery
Denovo urgency
by clinical assessment
Measured: 6 months after surgery
Denovo urgency
by clinical assessment
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Jun 2016
- Primary completionSep 2017
- Study completionSep 2017
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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296748
- Sponsor's protocol ID
- 151115
- Status last verified
- Oct 2017
- First submitted
- 25 Sep 2017
- Last updated
- 24 Oct 2017
- 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 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?
- ClinicalTrials.gov ID
- NCT03296748
- Acronym / sponsor ID
- 151115
- Conditions
- Stress Urinary Incontinence
- Keywords
- asymptomatic cystocele., stress urinary incontinence
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 28 Sep 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.
The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence
Detailed description
female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy .
| Arm | Type | Receives |
|---|---|---|
| TOT only group | Active comparator | Procedure: trans-obturator tape inside-out usingsoft tapes.60 patients with stress incontinence and asymptomatic grade 2 cystocele. |
| concomitant repair group | Active comparator | Procedure: trans-obturator tape inside-out usingsoft tapes., Procedure: anterior colporraphy63 patients with stress incontinence and asymptomatic grade 2 cystocele. |
Who may qualify
- Ages
- 23 to 56 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female patients
- genuine stress incontinence
Key exclusion criteria (1 listed)
- mixed 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 |
|---|---|---|
| trans-obturator tape inside-out usingsoft tapes.Also: anterior colporrhaphytrans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day. | Procedure or surgery | TOT only group, concomitant repair group |
| anterior colporraphy | Procedure or surgery | concomitant repair group |
Primary outcome
cure rate of stress incontinence
Time frame: 3 months after surgery
by clinical assessment
Denovo urgency
Time frame: 3 months after surgery
by clinical assessment
4 secondary outcomes
cure rate of stress incontinence
Time frame: 6 months after surgery
cure rate of stress incontinence
Time frame: 12 months after surgery
Denovo urgency
Time frame: 6 months after surgery
Denovo urgency
Time frame: 12 months after surgery
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 24 Oct 2017.
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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 2/3 study testing trans-obturator tape inside-out usingsoft tapes. and anterior colporraphy in people with Stress Urinary Incontinence, run by Kasr El Aini Hospital 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 3 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 24 Oct 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: 3 months after surgery). The study lists 2 primary outcomes in all. 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 24 Oct 2017.