HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial

NCT ID: NCT04143399

Last Updated: 2019-10-29

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

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-14

Study Completion Date

2019-06-10

Brief Summary

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

Detailed Description

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To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (\> 75 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 (Versa pulse 100W; Lumenis; Germany)

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 (Versa pulse 100W; Lumenis; Germany)

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
* failed medical treatment
* International Prostate Symptom Score (IPSS) \> 13
* a peak urinary flow rate (Qmax) \< 15 ml/sec
* a prostate size ≥ 75 gm

Exclusion Criteria

* presence of a urethral stricture
* neurological disorder
* bladder cancer
* prostate cancer
* previous history of bladder neck surgery or TURP
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed Said ElSheemy

Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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enmar I Habib

Role: STUDY_DIRECTOR

Cairo University

Locations

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Cairo University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Habib EI, ElSheemy MS, Hossam A, Morsy S, Hussein HA, Abdelaziz AY, Abdelazim MS, Fathy H. Holmium Laser Enucleation Versus Bipolar Plasmakinetic Resection for Management of Lower Urinary Tract Symptoms in Patients with Large-Volume Benign Prostatic Hyperplasia: Randomized-Controlled Trial. J Endourol. 2021 Feb;35(2):171-179. doi: 10.1089/end.2020.0636. Epub 2020 Oct 29.

Reference Type DERIVED
PMID: 32842769 (View on PubMed)

Other Identifiers

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62513

Identifier Type: -

Identifier Source: org_study_id

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