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KTP (Potassium-titanyl-phosphate) Laser Versus TUR-P (Transurethral Resection of Prostate)

NCT ID: NCT02011308

Last Updated: 2017-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

217 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to compare safety and efficacy of Green Light PVP (Photoselective Vaporisation of the Prostate) compared to TUR-P.

Detailed Description

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Conditions

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BPH (Benign Prostatic Hyperplasia)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Green Light Laser

Group Type ACTIVE_COMPARATOR

Green light Laser

Intervention Type DEVICE

Laser vs TURP

Transurethral Resection of the Prostate (TURP)

Intervention Type DEVICE

Laser vs TURP

TURP

Transurethral Resection of the Prostate

Group Type ACTIVE_COMPARATOR

Green light Laser

Intervention Type DEVICE

Laser vs TURP

Transurethral Resection of the Prostate (TURP)

Intervention Type DEVICE

Laser vs TURP

Interventions

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Green light Laser

Laser vs TURP

Intervention Type DEVICE

Transurethral Resection of the Prostate (TURP)

Laser vs TURP

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Men undergoing surgery for BPH

Exclusion Criteria

* Previous prostate surgery
* Carcinoma of the prostate
* Neurogenic bladder
* Bladder carcinoma
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Turku

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

South Ostrobothnia Health Care District

OTHER

Sponsor Role collaborator

Oulu University Hospital

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role lead

Responsible Party

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Hannu Koistinen

Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hannu T Koistinen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital

Locations

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Helsinki University Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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34/13/03/02/08

Identifier Type: -

Identifier Source: org_study_id