KTP Green Light Prostatectomy Compared With Open Prostatectomy

University of Helsinki

Status and phase: Completed; Phase 4

Conditions: BPH (Benign Prostatic Hyperplasia)

Treatments: Procedure: KTP Green Light Prostatectomy; Procedure: Open prostatectomy; Device: Green Light

Study type: Interventional

Funder types: Other

Identifiers

NCT02072499

164/13/03/02/08

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: Male

Ages: 40 to 95 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

KTP Green Light Prostatectomy

Experimental group

Description:

Device

Treatment:

Device: Green Light

Procedure: KTP Green Light Prostatectomy

Open prostatectomy

Active Comparator group

Description:

Surgical procedure

Treatment:

Procedure: Open prostatectomy