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

NCT ID: NCT03609229

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2020-08-01

Brief 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.

Conditions

Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Study group

Abdominal Sacrocolpopexy with burch technique

Group Type: EXPERIMENTAL

Burch

Intervention Type: PROCEDURE

polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve

Abdominal Sacrocolpopexy

Intervention Type: PROCEDURE

• 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.

control group

Abdominal Sacrocolpopexy without burch technique

Group Type: ACTIVE_COMPARATOR

Abdominal Sacrocolpopexy

Intervention Type: PROCEDURE

• 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.

Interventions

Burch

polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abbas

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abbas

Assiut, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

SCBU

Identifier Type: -

Identifier Source: org_study_id