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

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.

Study Overview

• Status: Completed
• Conditions: Prolapse
• Intervention / Treatment: Procedure: Burch; Procedure: Abdominal Sacrocolpopexy

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Assiut, Cairo, Egypt, 002
      • Ahmed Abbas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Abdominal Sacrocolpopexy with burch technique	Procedure: Burch; polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve; 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.
Active Comparator: control group; Abdominal Sacrocolpopexy without burch technique	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the percentage of stress incontinence post operative	(symptoms, stress testing, or treatment)	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 1, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Urination Disorders; Pathological Conditions, Anatomical; Elimination Disorders; Pelvic Organ Prolapse; Urinary Incontinence; Prolapse; Enuresis; Urinary Incontinence, Stress; Uterine Prolapse
• Other Study ID Numbers: SCBU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No