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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02073799
Other study ID # LaserP1
Secondary ID
Status Recruiting
Phase N/A
First received February 23, 2014
Last updated February 25, 2014
Start date February 2014

Study information

Verified date February 2014
Source Seoul National University Hospital
Contact Jae-Seung Paick, doctor of philosophy
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

Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively. The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.


Recruitment information / eligibility

Status Recruiting
Enrollment 486
Est. completion date
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of prostatic hyperplasia

- underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate

- 12-months follow-up data were available

Exclusion Criteria:

- previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Procedure:
Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)


Locations

Country Name City State
Korea, Republic of Department of Urology, 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 the subtotal storage symptom score of the International Prostate Symptom Score (IPSS) a reduction by = 50% of the subtotal storage symptom score according to the International Prostate Symptom Score (IPSS) after the surgery compared to baseline 12 months after surgery No
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