Prolapse Clinical Trial
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
NCT number | NCT03609229 |
Other study ID # | SCBU |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 1, 2018 |
Est. completion date | August 1, 2020 |
Verified date | August 2020 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | August 1, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Women with 3rd and 4th degree Apical prolapse Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Ahmed Abbas | Assiut | Cairo |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the percentage of stress incontinence post operative | (symptoms, stress testing, or treatment) | 3 months |
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