Back to results

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

Primary Purpose

Prolapse

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Burch

Abdominal Sacrocolpopexy

About this trial

This is an interventional prevention trial for Prolapse

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Ahmed Abbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Study group

control group

Arm Description

Abdominal Sacrocolpopexy with burch technique

Abdominal Sacrocolpopexy without burch technique

Outcomes

Primary Outcome Measures

the percentage of stress incontinence post operative

(symptoms, stress testing, or treatment)

Secondary Outcome Measures

Full Information

NCT ID

NCT03609229

First Posted

July 25, 2018

Last Updated

August 10, 2020

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03609229

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

September 1, 2018 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

August 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prolapse

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study group

Arm Type

Experimental

Arm Description

Abdominal Sacrocolpopexy with burch technique

Arm Title

control group

Arm Type

Active Comparator

Arm Description

Abdominal Sacrocolpopexy without burch technique

Intervention Type

Procedure

Intervention Name(s)

Burch

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Abdominal Sacrocolpopexy

Intervention Description

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.

Primary Outcome Measure Information:

Title

the percentage of stress incontinence post operative

Description

(symptoms, stress testing, or treatment)

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Ahmed Abbas

City

Assiut

State/Province

Cairo

ZIP/Postal Code

002

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs