Mixed Urinary Incontinence Surgical Trial

July 26, 2022 updated by: Hamdy Ahmed Saaid, Ain Shams Maternity Hospital

Surgical Management of Mixed Urinary Incontinence

Surgical management of mixed urinary incontinence

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study to evaluate role of anti-incontinent surgery Burch colposuspension Tension free vaginal tape Trans obturator tape for the management of mixed urinary incontinence .

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

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

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patients with Mixed urinary incontinence

Exclusion Criteria:

Women with associated gynecological surgery e.g. uterine prolapse, previous anti-incontinence surgery, intrinsic sphincter deficiency (ISD), and medical disorders affecting the bladder innervation as diabetes mellitus were excluded from the study. Women who improved on medical treatment with persistence of stress element only were also excluded.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Burch
Burch Colposuspension
Procedure: Burch Colposuspension
Anti-incontinent surgery
Experimental: Trans Obturator Tape
Trans Obturator Tape sling
Procedure: trans obturator tape
Anti-incontinent surgery
Experimental: Tension free vaginal tape
Tension free vaginal tape sling
Procedure: tension free vaginal tape
Anti-incontinent surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure of Mixed incontinence
Time Frame: 1 year
compare the 3 groups as regard cure rate of both Components of mixed incontinence
1 year

Collaborators and Investigators

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

Sponsor

Ain Shams Maternity Hospital

Investigators

  • Principal Investigator: Hamdy HA Ahmed Saaid, M.D, Fellow of OBS/GYN

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)

October 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

March 15, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUIT

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

product manufactured in and exported from the U.S.

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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