Transobturator Approach for Paravaginal Repair

Transobturator Approach for Paravaginal Repair a New Approach

A new technique for Applying sutures to the white line in paravaginal repair.

Study Overview

• Status: Completed
• Conditions: Cystocele
• Intervention / Treatment: Procedure: transobturator approach for paravaginal repair

Detailed Description

A new trial for transobturator repair of the paravaginal defect.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Urogynecology Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• paravaginal defect cystocele
• midline and paravaginal defect cystocele

Exclusion Criteria:

• uterine descent
• previous cystocele surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: cystocele; Arm: Patients with paravaginal defect cystocele Intervention: transobturator approach for paravaginal repair	Procedure: transobturator approach for paravaginal repair; using TOT needle to apply suturs to white line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
success rate	Evaluation of the postoperative degree of anterior vaginal wall descent using pelvic organ prolapse quantitative system	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Operative time	1 day
lateral vaginal fornices elevation	test is negative means success	3 month
Intraoperative blood loss	Blood loss during the operative procedure	1 day
Complications rate	Intraoperative and postoperative complications	1 week

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital
• Investigators: Study Chair: Hazem SH Samoor, Professor, Ain Shams Universty

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 25, 2017
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 12, 2016
• First Posted (ESTIMATE): April 13, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 4, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Pathological Conditions, Anatomical; Pelvic Organ Prolapse; Prolapse; Cystocele
• Other Study ID Numbers: PVRNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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