NCT02075736

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
11.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

14.5 years

First QC Date

February 24, 2014

Last Update Submit

March 5, 2024

Conditions

BPH (Benign Prostatic Hyperplasia)

Outcome Measures

Primary Outcomes (1)

  • Re-bleeding rate requiring hospitalization

    two months postoperatively

Secondary Outcomes (9)

  • IPSS (International Prostate Symptom Score)

    0, 3, 6 and 12 months

  • DAN-PSS (Danish Prostate Symptom Score)

    0, 3, 6 and 12 months

  • Maximum flow rate (Qmax)

    0, 3, 6 and 12 months

  • Residual urine

    0, 3, 6 and 12 months

  • Length of catheterization

    Participants will be followed for the duration of hospital stay, an expected maximum of one week

  • +4 more secondary outcomes

Study Arms (2)

KTP laser

EXPERIMENTAL

device

Procedure: KTP laser

TUR-P

ACTIVE COMPARATOR

device

Procedure: TUR-P

Interventions

KTP laserPROCEDURE
Also known as: Green laser
KTP laser
TUR-PPROCEDURE

device

TUR-P

Eligibility Criteria

Age40 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with anticoagulant medication undergoing surgery for BPH

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 3, 2014

Study Start

March 1, 2011

Primary Completion

August 31, 2025

Study Completion

December 31, 2025

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations

FI(1)