ProlapseNCT03609229
Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse
A study testing Burch and Abdominal Sacrocolpopexy in people with Prolapse, run by Assiut University at 1 site in Egypt.
Trial summary
Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Read more about this study
- Who is it for?
- Ages 40 to 80 years, women only
- Conditions the study is for
- Prolapse
- What is being tested?
- Burch and Abdominal Sacrocolpopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2018to 1 Aug 2020
- 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 40 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with 3rd and 4th degree Apical prolapse
Who cannot join
- Patients with previous failed surgical intervention
- Patients with medical disorders that may interfere with surgical interventions .
- Patients with apical prolapsed complaining of stress urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse. Randomized Controlled Trial
Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.
- Conditions
- Prolapse
- Being tested
- Burch, Abdominal Sacrocolpopexy
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BurchProcedure or surgery
polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve
Abdominal SacrocolpopexyProcedure or surgery
- By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra.
- The right-handed operator double gloves, and places the left hand in the vagina.
- With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon).
- Place three Ethibond J-shaped sutures on either side of the urethrovesical junction.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Abdominal Sacrocolpopexy with burch technique Receives: Procedure: Burch; Procedure: Abdominal Sacrocolpopexy |
| control group | Active comparator | Abdominal Sacrocolpopexy without burch technique Receives: Procedure: Abdominal Sacrocolpopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of stress incontinence post operative
(symptoms, stress testing, or treatment)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlapseStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609229
- Sponsor's protocol ID
- SCBU
- Status last verified
- Aug 2020
- First submitted
- 25 Jul 2018
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03609229
- Acronym / sponsor ID
- SCBU
- Conditions
- Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 1 Aug 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.
Urinary incontinence will develop after prolapse repair in approximately one quarter of patients with advanced pelvic organ prolapse who remain continent despite significant loss of anterior vaginal and pelvic organ support. Many women with advanced pelvic organ prolapse who choose to undergo surgical management also choose to undergo continence surgery in order to prevent new onset urinary incontinence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Procedure: Burch, Procedure: Abdominal SacrocolpopexyAbdominal Sacrocolpopexy with burch technique |
| control group | Active comparator | Procedure: Abdominal SacrocolpopexyAbdominal Sacrocolpopexy without burch technique |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with 3rd and 4th degree Apical prolapse
Key exclusion criteria (3 listed)
- Patients with previous failed surgical intervention
- Patients with medical disorders that may interfere with surgical interventions .
- Patients with apical prolapsed complaining of stress urinary 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 |
|---|---|---|
| Burchpolyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve | Procedure or surgery | Study group |
| Abdominal Sacrocolpopexy* By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra. * The right-handed operator double gloves, and places the left hand in the vagina. * With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon). * Place three Ethibond J-shaped sutures on either side of the urethrovesical junction. | Procedure or surgery | Study group, control group |
Primary outcome
the percentage of stress incontinence post operative
Time frame: 3 months
(symptoms, stress testing, or treatment)
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 12 Aug 2020.
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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 study testing Burch and Abdominal Sacrocolpopexy in people with Prolapse, run by Assiut 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 3 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 12 Aug 2020. 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?
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?
the percentage of stress incontinence post operative (time frame: 3 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 12 Aug 2020.