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NCT02242422 Clinical Trial

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

Stress Urinary Incontinence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02242422
Other study ID # MCho3
Secondary ID
Status Recruiting
Phase N/A
First received September 14, 2014
Last updated September 15, 2014
Start date August 2014

Study information
Verified date September 2014
Source DongGuk University
Contact Min Chul Cho, M.D., Ph.D.
Phone 82-31-961-7456
Email cmc1206@empal.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 90 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Dongguk University ilsan Hospital Goyang Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in total overactive bladder symptom score (OABSS) after surgery 1-week, and 1-, 3-, 6- and 12-months after surgery No
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