HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-04

Study Completion Date

2021-03-10

Brief Summary

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To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (\> 80 gm)

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Detailed Description

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To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (\> 80 gm)

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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holmium laser enucleation of the prostate

holmium laser enucleation of the prostate (HoLEP)

Group Type ACTIVE_COMPARATOR

holmium laser enucleation of the prostate

Intervention Type PROCEDURE

cystoscopic transurethral enucleation of the prostate using Holmium laser

bipolar resection of the prostate

bipolar resection of the prostate (BPEP)

Group Type ACTIVE_COMPARATOR

Bipolar resection of the prostate

Intervention Type PROCEDURE

cystoscopic transurethral resection of the prostate using bipolar energy

Interventions

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holmium laser enucleation of the prostate

cystoscopic transurethral enucleation of the prostate using Holmium laser

Intervention Type PROCEDURE

Bipolar resection of the prostate

cystoscopic transurethral resection of the prostate using bipolar energy

Intervention Type PROCEDURE

Other Intervention Names

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HoLEP BPRP

Eligibility Criteria

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Inclusion Criteria

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