NCT02011308

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2012

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

November 14, 2017

Status Verified

November 1, 2017

Enrollment Period

4.8 years

First QC Date

February 21, 2012

Last Update Submit

November 13, 2017

Conditions

BPH (Benign Prostatic Hyperplasia)

Outcome Measures

Primary Outcomes (1)

  • IPSS (International Prostate Symptom Score)

    symptom

    12 months

Secondary Outcomes (8)

  • DAN-PSS (Danish Prostate Symptom Score)

    3, 6 and 12 months

  • Maximum flow rate (Qmax)

    3, 6 and 12 months

  • Residual urine

    3, 6 and 12 months

  • Length of catheterization

    Postoperative recovery

  • Length of hospital stay

    Postoperative recovery

  • +3 more secondary outcomes

Study Arms (2)

Green Light Laser

ACTIVE COMPARATOR
Device: Green light LaserDevice: Transurethral Resection of the Prostate (TURP)

TURP

ACTIVE COMPARATOR

Transurethral Resection of the Prostate

Device: Green light LaserDevice: Transurethral Resection of the Prostate (TURP)

Interventions

Green light LaserDEVICE

Laser vs TURP

Green Light LaserTURP
Transurethral Resection of the Prostate (TURP)DEVICE

Laser vs TURP

Green Light LaserTURP

Eligibility Criteria

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

You may qualify if:

  • Men 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, 00350, Finland

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hannu T Koistinen, M.D.

    Helsinki University Central Hospital

    PRINCIPAL INVESTIGATOR

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
Urologist

Study Record Dates

First Submitted

February 21, 2012

First Posted

December 13, 2013

Study Start

January 1, 2011

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

November 14, 2017

Record last verified: 2017-11

Locations

FI(1)