Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-01

Study Completion Date

2019-03-08

Brief Summary

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To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.

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Detailed Description

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To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (\>80gm).

Conditions

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BPH With Urinary Obstruction Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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HoLEP holmium laser enucleation of the prostate

holmium laser enucleation of the prostate

Group Type ACTIVE_COMPARATOR

Holmium laser enucleation of the prostate

Intervention Type PROCEDURE

cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)

BPEP bipolar plasmakinetic enucleation of the prostate

bipolar plasmakinetic enucleation of the prostate

Group Type ACTIVE_COMPARATOR

Bipolar plasma kinetic enucleation of the prostate

Intervention Type PROCEDURE

cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)

Interventions

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Holmium laser enucleation of the prostate

cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)

Intervention Type PROCEDURE

Bipolar plasma kinetic enucleation of the prostate

cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)

Intervention Type PROCEDURE

Other Intervention Names

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HoLEP BPEP

Eligibility Criteria

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Inclusion Criteria

* Patients suffering from LUTS secondary to infravesical obstruction from BPH
* failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 80 gm