A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse

A New Technique for Sacrospinous-Sacrotuberous Fixation for the Treatment of Uterovaginal and Vaginal Vault Prolapse: A Randomized Controlled Trial

NCT03487328•Ain Shams University

View on ClinicalTrials.gov

Summary

This prospective interventional randomized controlled trial is conducted to compare a new technique for Sacrospinous-Sacrotuberous fixation with the traditional sacrospinous ligament fixation technique for treatment of uterovaginal and vaginal vault prolapse.

Eligibility

Age

40 - 60 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Age from 40 to 60 years.
•2. POP Q stage III \& IV
•3. Uterovaginal prolapse.
•4. Vaginal vault prolapse.
•5. BMI \>35.

Exclusion Criteria

•1. Age \> 40 years or \< 60 years.
•2. POP Q stage I or II.
•3. BMI \< 35.
•4. Previous repair of uterovaginal or vaginal vault prolapse.
•5. Comorbidity with Stress Urinary Incontinence.
•6. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions.
•7. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.

Locations (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Key Dates

Start Date

March 21, 2018

Primary Completion Date

May 1, 2020

Completion Date

May 1, 2020

Last Updated

July 8, 2020

Enrollment

ACTUAL participants

Conditions

Uterovaginal and Vaginal Vault Prolapse

Interventions

Sacrospinous-Sacrotuberous fixation

PROCEDURE