KTP Green Light Prostatectomy Compared With Open Prostatectomy

BPH (Benign Prostatic Hyperplasia) Clinical Trial

Official title:

The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (180W) Compared With Open Prostatectomy When Treating Benign Prostatic Hyperplasia, a Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072499
• Other study ID #: 164/13/03/02/08
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2013
• Last updated: November 13, 2017
• Start date: September 2011
• Est. completion date: October 2017

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 open prostatectomy when treating benign prostatic hyperplasia (BPH).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 95 Years

Eligibility

Inclusion Criteria:

• Men undergoing surgery for BPH with prostate size more than 100cc

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

Procedure:
• KTP Green Light Prostatectomy

Device:
• Green Light

Procedure:
• Open prostatectomy

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPSS (International Prostate Symptom Score)	symptom score	12 months
Secondary	DAN-PSS (Danish Prostate Symptom Score)	symptom score	0, 3, 6 and 12 months
Secondary	Maximum flow rate (Qmax)		0, 3, 6 and 12 months
Secondary	Residual urine		0, 3, 6 and 12 months
Secondary	Length of catheterization		Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Secondary	Perioperative bleeding		Time of operation
Secondary	IIEF (International Index of Erectile Function questionnaire)		0,12 months
Secondary	Prostate volume measured with TRUS (transrectal ultrasound)		0, 12 moths
Secondary	Rate of unscheduled hospital contacts		12 months
Secondary	IPSS (International Prostate Symptom Score)		0, 3 and 6 months