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NCT03609229 Clinical Trial

Outcomes After Sacrocolpopexy With and Without Burch to Prevent Stress Urinary Incontinence in 3rd and 4th Degree Apical Uterine Prolapse

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

Clinical Trial Details — Status: Completed

Administrative data
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

Study information
Verified date August 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Burch
polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve
• 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.

Locations
Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
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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