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NCT02243540 Clinical Trial

Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy

Prostatic Hyperplasia Clinical Trial

Official title:
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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02243540
Other study ID # JSPaick1
Secondary ID
Status Recruiting
Phase N/A
First received September 14, 2014
Last updated September 15, 2014
Start date April 2014

Study information
Verified date September 2014
Source Seoul National University Hospital
Contact Jae-Seung Paick, M.D., Ph.D.
Phone 82-2-2072-2422
Email jspaick@snu.ac.kr
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1828
Est. completion date
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 90 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline bladder voiding efficiency at 12 months after surgery bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume) 12-months postoperatively No
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