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

Not Applicable

Completed

• Conditions: BPH With Urinary Obstruction; Male
• Interventions: Procedure: Bipolar resection of the prostate; Procedure: holmium laser enucleation of the prostate

• Registration Number: NCT04935151
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-12-04
• Primary Completion: 2018-03-06
• Study Completion: 2021-03-10
• Status Verified: 2021-06
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-22
• Last Update Posted: 2021-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 112

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

Exclusion Criteria

• presence of a urethral stricture
• neurological disorder
• bladder cancer
• prostate cancer
• previous history of bladder neck surgery or TURP

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bipolar resection of the prostate	Bipolar resection of the prostate	bipolar resection of the prostate (BPEP)
holmium laser enucleation of the prostate	holmium laser enucleation of the prostate	holmium laser enucleation of the prostate (HoLEP)

Primary Outcome Measures

Name	Time	Method
hemoglobin drop postoperatively (gm/dL)	within two hours after surgery	change in hemoglobin concentration postoperatively vs preoperatively

Secondary Outcome Measures

Name	Time	Method
operative duration in minutes	Time lapsed during surgery	operative duration
Hospital stay	From time of randomisation up to last day of admission in hospital (in days) up to 30 days	Hospitalisation starting from day of surgery till the day of discharge from Hospital in days
blood transfusion	during surgery and hospitalisation up to 10 days	rate of blood transfusion

Trial Locations

Locations (2)

Theodor Bilharz research institute; 🇪🇬 Giza, Egypt

Cairo University Hospitals; 🇪🇬 Cairo, Egypt