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

Primary Purpose

Uterovaginal and Vaginal Vault Prolapse

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Sacrospinous-Sacrotuberous fixation

About this trial

This is an interventional treatment trial for Uterovaginal and Vaginal Vault Prolapse focused on measuring treatment

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Age from 40 to 60 years.
POP Q stage III & IV
Uterovaginal prolapse.
Vaginal vault prolapse.
BMI >35.

Exclusion Criteria:

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

Sites / Locations

Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Modified technique for Sacrospinous-Sacrotuberous Fixation

Conventional technique for Sacrospinous-Sacrotuberous Fixation

Arm Description

Modified technique for Sacrospinous-Sacrotuberous Fixation

Outcomes

Primary Outcome Measures

Number of participants with recurrence of uterovaginal and vaginal vault prolapse

Secondary Outcome Measures

blood loss

Injury to surrounding structures

Number of participants that experience injury of important surrounding structure intraoperative

operative time

Full Information

NCT ID

NCT03487328

First Posted

March 21, 2018

Last Updated

July 7, 2020

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03487328

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 21, 2018 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

May 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Uterovaginal and Vaginal Vault Prolapse

Keywords

treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Modified technique for Sacrospinous-Sacrotuberous Fixation

Arm Type

Active Comparator

Arm Description

Modified technique for Sacrospinous-Sacrotuberous Fixation

Arm Title

Conventional technique for Sacrospinous-Sacrotuberous Fixation

Arm Type

Active Comparator

Arm Description

Modified technique for Sacrospinous-Sacrotuberous Fixation

Intervention Type

Procedure

Intervention Name(s)

Sacrospinous-Sacrotuberous fixation

Intervention Description

Sacrospinous-Sacrotuberous fixation

Primary Outcome Measure Information:

Title

Number of participants with recurrence of uterovaginal and vaginal vault prolapse

Time Frame

1 year

Secondary Outcome Measure Information:

Title

blood loss

Time Frame

intraoperative

Title

Injury to surrounding structures

Description

Number of participants that experience injury of important surrounding structure intraoperative

Time Frame

intraoperative

Title

operative time

Time Frame

intraoperative

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age from 40 to 60 years. POP Q stage III & IV Uterovaginal prolapse. Vaginal vault prolapse. BMI >35. Exclusion Criteria: Age > 40 years or < 60 years. POP Q stage I or II. BMI < 35. Previous repair of uterovaginal or vaginal vault prolapse. Comorbidity with Stress Urinary Incontinence. Presence of persistent risk factor increasing intra-abdominal pressure e.g. chronic chest conditions. Any significant comorbidity or psychiatric disorder that would compromise patient's consent.

Facility Information:

Facility Name

Ain Shams University Maternity Hospital

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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