- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02243540
Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy
September 15, 2014 updated by: Jae-Seung Paick, Seoul National University Hospital
Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
The aim of this study was to evaluate an impact of preoperative bladder underactivity on treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to compare it between the two types of surgery for benign prostatic hyperplasia.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
1828
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
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Seoul, Korea, Republic of, 110-744
- Recruiting
- Seoul National University Hospital
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Contact:
- Jae-Seung Paick, M.D., Ph.D.
- Phone Number: 2422 82-2-2072-2422
- Email: jspaick@snu.ac.kr
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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 (PVP) or holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia refractory to medical treatment
Description
Inclusion Criteria:
- patients in whom 12-month follow-up data were available
Exclusion Criteria:
- a previous diagnosis of urethral stricture
- prostate or bladder carcinoma
- neurogenic bladder disease
- a previous history of urological surgery
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline bladder voiding efficiency at 12 months after surgery
Time Frame: 12-months postoperatively
|
bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume)
|
12-months postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jae-Seung Paick, M.D., Ph.D., Seoul National University 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
April 1, 2014
Primary Completion (Anticipated)
September 1, 2014
Study Registration Dates
First Submitted
September 14, 2014
First Submitted That Met QC Criteria
September 15, 2014
First Posted (Estimate)
September 18, 2014
Study Record Updates
Last Update Posted (Estimate)
September 18, 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
- JSPaick1
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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