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Clinical Trials/NCT02011308
NCT02011308CompletedNot Applicable

The Effect of KTP Green Light Prostatectomy (120W) Compared With TUR-P When Treating Benign Prostatic Hyperplasia (BPH), a Prospective Randomized Study

University of Helsinki2 sites in 1 country217 target enrollmentStarted: January 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
217
Locations
2
Primary Endpoint
IPSS (International Prostate Symptom Score)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 90 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Men undergoing surgery for BPH

Exclusion Criteria

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

Arms & Interventions

TURP

Active Comparator

Transurethral Resection of the Prostate

Intervention: Green light Laser (Device)

TURP

Active Comparator

Transurethral Resection of the Prostate

Intervention: Transurethral Resection of the Prostate (TURP) (Device)

Green Light Laser

Active Comparator

Intervention: Green light Laser (Device)

Green Light Laser

Active Comparator

Intervention: Transurethral Resection of the Prostate (TURP) (Device)

Outcomes

Primary Outcomes

IPSS (International Prostate Symptom Score)

Time Frame: 12 months

symptom

Secondary Outcomes

  • DAN-PSS (Danish Prostate Symptom Score)(3, 6 and 12 months)
  • Perioperative bleeding(Time of operation)
  • Maximum flow rate (Qmax)(3, 6 and 12 months)
  • Length of hospital stay(Postoperative recovery)
  • IIEF (International Index of Erectile Function questionnaire)(12 months)
  • Length of catheterization(Postoperative recovery)
  • Residual urine(3, 6 and 12 months)
  • TRUS (transrectal ultrasound)(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hannu Koistinen

Urologist

University of Helsinki

Study Sites (2)

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