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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03609229

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prolapse	Procedure: Burch Procedure: Abdominal Sacrocolpopexy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Jun 30, 2020

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

the percentage of stress incontinence post operative [3 months]
(symptoms, stress testing, or treatment)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmed Abbas	Assiut	Cairo	Egypt	002

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohamed Abbas, Principal investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT03609229

Other Study ID Numbers:

SCBU

First Posted:

Aug 1, 2018

Last Update Posted:

Aug 12, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Urinary Incontinence

Enuresis

Urinary Incontinence, Stress

Uterine Prolapse

Prolapse

Study Results

No Results Posted as of Aug 12, 2020