KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)

BPH (Benign Prostatic Hyperplasia) Clinical Trial

Official title:

The Effect of KTP Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia (BPH), a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011308
• Other study ID #: 34/13/03/02/08
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: November 13, 2017
• Start date: January 2011
• Est. completion date: October 2015

Study information

• Verified date: November 2017
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Men undergoing surgery for BPH

Exclusion Criteria:

• Previous prostate surgery

• Carcinoma of the prostate

• Neurogenic bladder

• Bladder carcinoma

Related Conditions & MeSH terms

• BPH (Benign Prostatic Hyperplasia)
• Hyperplasia
• Prostatic Hyperplasia

Intervention

Device:
• Green light Laser
Laser vs TURP
• Transurethral Resection of the Prostate (TURP)
Laser vs TURP

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (5)

Lead Sponsor	Collaborator
Helsinki University	Oulu University Hospital, South Ostrobothnia Health Care District, University of Tampere, University of Turku

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS (International Prostate Symptom Score)	symptom	12 months
Secondary	DAN-PSS (Danish Prostate Symptom Score)	symptom	3, 6 and 12 months
Secondary	Maximum flow rate (Qmax)		3, 6 and 12 months
Secondary	Residual urine		3, 6 and 12 months
Secondary	Length of catheterization		Postoperative recovery
Secondary	Length of hospital stay		Postoperative recovery
Secondary	Perioperative bleeding		Time of operation
Secondary	IIEF (International Index of Erectile Function questionnaire)	Erectile Dysfunction	12 months
Secondary	TRUS (transrectal ultrasound)	Measurement of prostate size	12 months