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

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.

Study Overview

• Status: Completed
• Conditions: Uterovaginal and Vaginal Vault Prolapse
• Intervention / Treatment: Procedure: Sacrospinous-Sacrotuberous fixation

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Modified technique for Sacrospinous-Sacrotuberous Fixation	Procedure: Sacrospinous-Sacrotuberous fixation; Sacrospinous-Sacrotuberous fixation
Active Comparator: Conventional technique for Sacrospinous-Sacrotuberous Fixation; Modified technique for Sacrospinous-Sacrotuberous Fixation	Procedure: Sacrospinous-Sacrotuberous fixation; Sacrospinous-Sacrotuberous fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with recurrence of uterovaginal and vaginal vault prolapse	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time		intraoperative
blood loss		intraoperative
Injury to surrounding structures	Number of participants that experience injury of important surrounding structure intraoperative	intraoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2018
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: March 21, 2018
• First Submitted That Met QC Criteria: April 2, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: treatment
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: AS1729

Drug and device information, study documents

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