Correction of Asymptomatic 2nd Degree Cystocele in Patient With Stress Incontinence

October 23, 2017 updated by: sarah mohamed hassan, Kasr El Aini Hospital

Is There Any Value of Concomitant Repair of Asymptomatic Grade II Anterior Vaginal Wall Prolapse During Mid Urethral Sling Surgery for Stress Urinary Incontinence ?

The aim of our study is to assess the value of concomitant surgical correction of asymptomatic grade II anterior vaginal wall prolapse with the placement of midurethral sling for treatment of female patients with stress incontinence

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

female patients with stress urinary incontinence and asymptomatic grade II anterior vaginal wall prolapse were divided into Group A: treated only with trans-obturator tape (TOT) and group B where' TOT was associated with anterior colporrhaphy and the outcome is compared.

Study Type

Interventional

Enrollment (Actual)

123

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr El Ainiy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female patients

  • genuine stress incontinence

    • asymptomatic cystocele

Exclusion Criteria:

  • mixed incontinence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TOT only group
60 patients with stress incontinence and asymptomatic grade 2 cystocele.
Procedure: trans-obturator tape inside-out usingsoft tapes.
trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
Other Names:
  • anterior colporrhaphy
Active Comparator: concomitant repair group
63 patients with stress incontinence and asymptomatic grade 2 cystocele.
Procedure: trans-obturator tape inside-out usingsoft tapes.
trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
Other Names:
  • anterior colporrhaphy
Procedure: anterior colporraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure rate of stress incontinence
Time Frame: 3 months after surgery
by clinical assessment
3 months after surgery
Denovo urgency
Time Frame: 3 months after surgery
by clinical assessment
3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure rate of stress incontinence
Time Frame: 6 months after surgery
by clinical assessment
6 months after surgery
cure rate of stress incontinence
Time Frame: 12 months after surgery
by clinical assessment
12 months after surgery
Denovo urgency
Time Frame: 6 months after surgery
by clinical assessment
6 months after surgery
Denovo urgency
Time Frame: 12 months after surgery
by clinical assessment
12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 25, 2017

First Submitted That Met QC Criteria

September 27, 2017

First Posted (Actual)

September 28, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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