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KTP Green Light Prostatectomy Compared With Open Prostatectomy

Primary Purpose

BPH (Benign Prostatic Hyperplasia)

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
KTP Green Light Prostatectomy
Green Light
Open prostatectomy
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 - 95 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KTP Green Light Prostatectomy

Open prostatectomy

Arm Description

Device

Surgical procedure

Outcomes

Primary Outcome Measures

IPSS (International Prostate Symptom Score)
symptom score

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2013
Last Updated
November 13, 2017
Sponsor
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT02072499
Brief Title
KTP Green Light Prostatectomy Compared With Open Prostatectomy
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
Study Type
Interventional

2. Study Status

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

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 Vaporisation of the Prostate) compared to open prostatectomy when treating benign prostatic hyperplasia (BPH).

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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KTP Green Light Prostatectomy
Arm Type
Experimental
Arm Description
Device
Arm Title
Open prostatectomy
Arm Type
Active Comparator
Arm Description
Surgical procedure
Intervention Type
Procedure
Intervention Name(s)
KTP Green Light Prostatectomy
Intervention Type
Device
Intervention Name(s)
Green Light
Intervention Type
Procedure
Intervention Name(s)
Open prostatectomy
Primary Outcome Measure Information:
Title
IPSS (International Prostate Symptom Score)
Description
symptom score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
DAN-PSS (Danish Prostate Symptom Score)
Description
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 two weeks
Title
Length of hospital stay
Time Frame
Participants will be followed for the duration of hospital stay, an expected maximum of two weeks
Title
Perioperative bleeding
Time Frame
Time of operation
Title
IIEF (International Index of Erectile Function questionnaire)
Time Frame
0,12 months
Title
Prostate volume measured with TRUS (transrectal ultrasound)
Time Frame
0, 12 moths
Title
Rate of unscheduled hospital contacts
Time Frame
12 months
Title
IPSS (International Prostate Symptom Score)
Time Frame
0, 3 and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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 Open Prostatectomy

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