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

Primary Purpose

BPH (Benign Prostatic Hyperplasia)

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
KTP laser
TUR-P
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 with anticoagulant medication 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

Experimental

Active Comparator

Arm Label

KTP laser

TUR-P

Arm Description

device

device

Outcomes

Primary Outcome Measures

Re-bleeding rate requiring hospitalization

Secondary Outcome Measures

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

Full Information

First Posted
February 24, 2014
Last Updated
November 25, 2020
Sponsor
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT02075736
Brief Title
KTP Green Light Prostatectomy Compared With TUR-P in High Risk Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki

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 Vaporization of the Prostate) compared to TUR-P in high risk patients

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
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KTP laser
Arm Type
Experimental
Arm Description
device
Arm Title
TUR-P
Arm Type
Active Comparator
Arm Description
device
Intervention Type
Procedure
Intervention Name(s)
KTP laser
Other Intervention Name(s)
Green laser
Intervention Type
Procedure
Intervention Name(s)
TUR-P
Intervention Description
device
Primary Outcome Measure Information:
Title
Re-bleeding rate requiring hospitalization
Time Frame
two months postoperatively
Secondary Outcome Measure Information:
Title
IPSS (International Prostate Symptom Score)
Description
symptom score
Time Frame
0, 3, 6 and 12 months
Title
DAN-PSS (Danish Prostate Symptom Score)
Time Frame
0, 3, 6 and 12 months
Title
Maximum flow rate (Qmax)
Time Frame
0, 3, 6 and 12 months
Title
Residual urine
Time Frame
0, 3, 6 and 12 months
Title
Length of catheterization
Time Frame
Participants will be followed for the duration of hospital stay, an expected maximum of one week
Title
Length of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected maximum of one week
Title
Perioperative bleeding
Time Frame
Time of operation
Title
IIEF (International Index of Erectile Function) questionnaire
Time Frame
0,12 months
Title
TRUS (transrectal ultrasound)
Time Frame
0, 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 with anticoagulant medication undergoing surgery for BPH Exclusion Criteria: Previous prostate surgery Carcinoma of the prostate Neurogenic bladder Bladder carcinoma
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

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

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