KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients

BPH (Benign Prostatic Hyperplasia) Clinical Trial

Official title:

The Effect of KTP (Potassium-titanyl-phosphate) Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia in High Risk Patients, A Prospective Randomized Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02075736
• Other study ID #: 35/13/03/02/08
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2011
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: University of Helsinki
• 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 Vaporization of the Prostate) compared to TUR-P in high risk patients

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 90 Years

Eligibility

Inclusion Criteria:

• Men with anticoagulant medication 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

Procedure:
• KTP laser

• TUR-P
device

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-bleeding rate requiring hospitalization		two months postoperatively
Secondary	IPSS (International Prostate Symptom Score)	symptom score	0, 3, 6 and 12 months
Secondary	DAN-PSS (Danish Prostate 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 one week
Secondary	Length of hospital stay		Participants will be followed for the duration of hospital stay, an expected maximum of one week
Secondary	Perioperative bleeding		Time of operation
Secondary	IIEF (International Index of Erectile Function) questionnaire		0,12 months
Secondary	TRUS (transrectal ultrasound)		0, 12 months