Impact of 80 W KTP Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia

Benign Prostatic Hyperplasia Clinical Trial

Official title:

Impact of 80 Watt KTP Photoselective Laser Vaporization Prostatectomy on Severity of Obstruction in Benign Prostatic Hyperplasia: 6-Month Results of a Nonrandomized Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00908427
• Other study ID #: 2004-05-09
• Status: Completed
• Phase: N/A
• First received: May 22, 2009
• Last updated: May 22, 2009
• Start date: June 2004
• Est. completion date: September 2007

Study information

• Verified date: May 2009
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compared the efficacy of 80W KTP photoselective laser vaporization prostatectomy (PVP) and transurethral resection of the prostate (TURP) in reducing the volume of prostate and relieving the obstruction in men with benign prostatic hyperplasia (BPH) on non-randomized controlled design.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: September 2007
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Symptomatic BPH

• International Score Prostate Symptom (IPSS) of 13 or greater

• prostate volume of 30 to 100 ML

• Peak urinary flow rate (Qmax) less than 15 mL/s with a voided volume of >125 mL and a PVR <350mL

• Able to give fully informed consent

Exclusion Criteria:

• Subjects with histological diagnosis of prostate cancer

• Subjects with history of chronic urinary retention

• Subjects with urethral stricture,

• Subjects with bladder neck contracture

• Subjects with urinary tract infection

• Subjects with prostate volume on TRUS of >100 mL

• Subjects with suspected neurogenic bladder dysfunction

• Subjects who, in the opinion of investigator, are not likely to complete the study for whatever reason

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Hyperplasia
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia

Intervention

Procedure:
• photoselective vaporization prostatectomy (PVP)
PVP using 80 W KTP laser with a Greenlight system (GreenLight PVTM, Laserscope®, San Jose, CA)
• Transurethral resection of the prostate
Standard transurethral resection of the prostate using electrocautery loop

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The changes of bladder outlet obstruction index (BOOI)		6months	No
Secondary	The changes of Quality of Life (QoL) parameters		6, 12 months	No
Secondary	The changes of Uroflowmetry (UFM) and Postvoid residual urine(PVR)		6, 12 months	No
Secondary	The changes of detrusor pressure at maximum flow rate (PdetQmax)parameters		6months	No
Secondary	The changes of International Prostatic Symptom Scores (IPSS)		6, 12 months	No
Secondary	The changes of Schafer obstruction grade parameters		6months	No
Secondary	The changes of prostate volume		6, 12 months	No
Secondary	postoperative catheterization days		immediate postoperative period	Yes
Secondary	Complications		During all study periods	Yes
Secondary	The changes of the hemoglobin and the serum sodium and the serum PSA		immediate postoperative period	Yes
Secondary	The change of IIEF score		6, 12 months	Yes