- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02243085
Predictors of de Novo Urge Urinary Incontinence After Photoselective Vaporization of the Prostate
September 15, 2014 updated by: Min Chul Cho, DongGuk University
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
126
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
-
-
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
40 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
men who underwent photoselective vaporization of the prostate using 80 watt potassium-titanyl-phosphate (KTP) laser or 120 watt high-power-system (HPS) laser for benign prostatic hyperplasia refractory to medical treatment
Description
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 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 |
---|
photoselective vaporization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
de novo urge urinary incontinence at 6 months after surgery
Time Frame: 6 months postoperatively
|
de novo urge urinary incontinence: OABSS (overactive bladder symptom score) question 4 of ≥ 2
|
6 months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 1, 2014
Study Registration Dates
First Submitted
September 13, 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
- MCho2
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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