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

Not Applicable

Completed

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

• Registration Number: NCT04143399
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (\> 75 gm).

Study Timeline

• Study Start: 2016-02-14
• Primary Completion: 2019-05-01
• Study Completion: 2019-06-10
• Status Verified: 2019-10
• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-10-26
• Last Update Submitted: 2019-10-26
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 145

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Hospital stay in days	immediately after surgery	Hospital stay
operative duration in minutes	during surgery	operative duration
hemoglobin drop postoperatively (gm/dL)	Immediate postoperatively	difference in hemoglobin concentration postoperatively vs preoperatively

Secondary Outcome Measures

Name	Time	Method
post-voiding residual urine	Two years	postvoiding residual urine (ml)
urine flow	Two years	Qmax (ml/s),
complications (%)	Two years	intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.
International prostate symptom score (IPSS)	Two years	an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom
Quality of life (QoL)	Two years	section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)
Catheter duration	immediate postoperatively	Catheter duration in hours

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt