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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02243085
Other study ID # MCho2
Secondary ID
Status Recruiting
Phase N/A
First received September 13, 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 investigate the incidence of de novo urge urinary incontinence after the photoselective vaporization of the prostate for benign prostatic hyperplasia using the validated overactive bladder symptom score, and to determine the predictors of de novo urge urinary incontinence following the photoselective vaporization of the prostate.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- men in whom 6-months follow-up data were available

- men who did not complain of urge urinary incontinence based on the OABSS (overactive symptom score): OABSS question 4 score of = 1

Exclusion Criteria:

- previous prostate or bladder surgery

- a previous diagnosis of urethral stricture or prostate carcinoma or bladder cancer or neurogenic bladder disease

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


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 de novo urge urinary incontinence at 6 months after surgery de novo urge urinary incontinence: OABSS (overactive bladder symptom score) question 4 of = 2 6 months postoperatively No
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