Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery

September 15, 2014 updated by: Min Chul Cho, DongGuk University

Serial Changes in Lower Urinary Tract Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery for Treatment of Female Stress Urinary Incontinence

The aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Contact

  • Name: Min Chul Cho, M.D., Ph.D.
  • Phone Number: 7456 82-31-961-7456
  • Email: cmc1206@empal.com

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang, Gyeonggi-do, Korea, Republic of, 410-773
        • Recruiting
        • Dongguk University Ilsan Hospital
        • Contact:
          • Min Chul Cho, M.D., Ph.D.
          • Phone Number: 7456 82-31-961-7456
          • Email: cmc1206@empal.com

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women who underwent transobturator tape surgery for treatment of female stress urinary incontinence

Description

Inclusion Criteria:

  • women who underwent transobturator tape surgery for treatment of female stress urinary incontinence

Exclusion Criteria:

  • any urinary tract infection
  • pregnancy
  • bladder malignancy
  • postoperative follow-up of less than 12 months

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

Cohorts and Interventions

Group / Cohort
transobturator tape

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in total overactive bladder symptom score (OABSS) after surgery
Time Frame: 1-week, and 1-, 3-, 6- and 12-months after surgery
1-week, and 1-, 3-, 6- and 12-months after surgery

Collaborators and Investigators

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

Sponsor

DongGuk University

Investigators

  • Principal Investigator: Min Chul Cho, M.D., Ph.D., DongGuk University

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

August 1, 2014

Primary Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

September 14, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (Estimate)

September 17, 2014

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 15, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCho3

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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