Urodynamic Study and Stress Incontinence

September 28, 2017 updated by: sarah mohamed hassan, Kasr El Aini Hospital

Role of Urodynamic Study Before Surgery for Stress Urinary Incontinence.

A trial to answer the debatabal question about the role of urodynamic study in surgical treatment for stress urinary incontinence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

group of patients complaining of stress urinary incontinence and candidate for sling surgery were randomaly divided into 2 groups either to have urodynamic study before surgery or not.

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Phase 2

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
        • Recruiting
        • 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

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • stress urinary incontinence

Exclusion Criteria:

  • mixed incontinence
  • recurrent cases

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: urodynamics study group
65 patients with stress urinary incontinence were randomly chosen to have urodynamic study before surgery
Procedure: sling surgery
transoburator vaginal tape ,inside out procedure under spinal anathesia
Active Comparator: surgery only group
60 patients with stress urinary incontinence were randomly chosen to have surgery without urodynamics study
Procedure: sling surgery
transoburator vaginal tape ,inside out procedure under spinal anathesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure of stress incontinence
Time Frame: 1 week after surgery
by clinical assessment
1 week after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure of stress incontinence
Time Frame: one month after surgery
by clinical assessment
one month after surgery
cure of stress incontinence
Time Frame: 3 months after surgery
by clinical assessment
3 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)

January 15, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

October 4, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11279

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

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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