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

Primary Purpose

BPH (Benign Prostatic Hyperplasia)

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Green light Laser
Transurethral Resection of the Prostate (TURP)
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH (Benign Prostatic Hyperplasia)

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Men undergoing surgery for BPH

Exclusion Criteria:

  • Previous prostate surgery
  • Carcinoma of the prostate
  • Neurogenic bladder
  • Bladder carcinoma

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Green Light Laser

TURP

Arm Description

Transurethral Resection of the Prostate

Outcomes

Primary Outcome Measures

IPSS (International Prostate Symptom Score)
symptom

Secondary Outcome Measures

DAN-PSS (Danish Prostate Symptom Score)
symptom
Maximum flow rate (Qmax)
Residual urine
Length of catheterization
Length of hospital stay
Perioperative bleeding
IIEF (International Index of Erectile Function questionnaire)
Erectile Dysfunction
TRUS (transrectal ultrasound)
Measurement of prostate size

Full Information

First Posted
February 21, 2012
Last Updated
November 13, 2017
Sponsor
University of Helsinki
Collaborators
University of Turku, Tampere University, South Ostrobothnia Health Care District, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02011308
Brief Title
KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)
Official Title
The Effect of KTP Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia (BPH), a Prospective Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki
Collaborators
University of Turku, Tampere University, South Ostrobothnia Health Care District, Oulu University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPH (Benign Prostatic Hyperplasia)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Green Light Laser
Arm Type
Active Comparator
Arm Title
TURP
Arm Type
Active Comparator
Arm Description
Transurethral Resection of the Prostate
Intervention Type
Device
Intervention Name(s)
Green light Laser
Intervention Description
Laser vs TURP
Intervention Type
Device
Intervention Name(s)
Transurethral Resection of the Prostate (TURP)
Intervention Description
Laser vs TURP
Primary Outcome Measure Information:
Title
IPSS (International Prostate Symptom Score)
Description
symptom
Time Frame
12 months
Secondary Outcome Measure Information:
Title
DAN-PSS (Danish Prostate Symptom Score)
Description
symptom
Time Frame
3, 6 and 12 months
Title
Maximum flow rate (Qmax)
Time Frame
3, 6 and 12 months
Title
Residual urine
Time Frame
3, 6 and 12 months
Title
Length of catheterization
Time Frame
Postoperative recovery
Title
Length of hospital stay
Time Frame
Postoperative recovery
Title
Perioperative bleeding
Time Frame
Time of operation
Title
IIEF (International Index of Erectile Function questionnaire)
Description
Erectile Dysfunction
Time Frame
12 months
Title
TRUS (transrectal ultrasound)
Description
Measurement of prostate size
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men undergoing surgery for BPH Exclusion Criteria: Previous prostate surgery Carcinoma of the prostate Neurogenic bladder Bladder carcinoma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu T Koistinen, M.D.
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00350
Country
Finland

12. IPD Sharing Statement

Learn more about this trial

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

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