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

Not Applicable

Completed

• Conditions: BPH With Urinary Obstruction; Male

• Registration Number: NCT03998150
• Lead Sponsor: Cairo University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2016-11-01
• Primary Completion: 2018-02-14
• Study Completion: 2019-03-08
• Status Verified: 2019-06
• Study First Submitted: 2019-06-14
• Study First Submitted QC: 2019-06-24
• Last Update Submitted: 2019-06-25
• Study First Posted: 2019-06-26
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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

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

Primary Outcome Measures

Name	Time	Method
hemoglobin drop postoperatively (gm/dL)	Immediate postoperatively	difference in hemoglobin concentration postoperatively vs preoperatively
operative time	during surgery	operative time in minutes

Secondary Outcome Measures

Name	Time	Method
post-voiding residual urine	one year	postvoiding residual urine (ml)
International prostate symptom score (IPSS)	one year	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) section of International prostate symptom score (IPSS)	one year	one question scored from 0 up to 6 (6 is worst)
urine flow	one year	Qmax (ml/s),
complications (%)	one year	intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt