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

Uterovaginal and Vaginal Vault Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03487328
• Other study ID #: AS1729
• Status: Completed
• Phase: N/A
• Start date: March 21, 2018
• Est. completion date: May 1, 2020

Study information

• Verified date: July 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Uterovaginal and Vaginal Vault Prolapse

Intervention

Procedure:
• Sacrospinous-Sacrotuberous fixation
Sacrospinous-Sacrotuberous fixation

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with recurrence of uterovaginal and vaginal vault prolapse		1 year
Secondary	blood loss		intraoperative
Secondary	Injury to surrounding structures	Number of participants that experience injury of important surrounding structure intraoperative	intraoperative
Secondary	operative time		intraoperative