HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial
Holmium Laser Enucleation vs Bipolar Resection of a Large Volume BPH: a Randomised Controlled Study
1 other identifier
interventional
145
1 country
1
Brief Summary
To compare bipolar resection versus holmium laser enucleation for management of large BPH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2019
CompletedFirst Submitted
Initial submission to the registry
October 26, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedOctober 29, 2019
October 1, 2019
3.2 years
October 26, 2019
October 26, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
hemoglobin drop postoperatively (gm/dL)
difference in hemoglobin concentration postoperatively vs preoperatively
Immediate postoperatively
operative duration in minutes
operative duration
during surgery
Hospital stay in days
Hospital stay
immediately after surgery
Secondary Outcomes (6)
complications (%)
Two years
urine flow
Two years
post-voiding residual urine
Two years
International prostate symptom score (IPSS)
Two years
Quality of life (QoL)
Two years
- +1 more secondary outcomes
Study Arms (2)
holmium laser enucleation of the prostate
ACTIVE COMPARATORholmium laser enucleation of the prostate (HoLEP)
bipolar resection of the prostate
ACTIVE COMPARATORbipolar resection of the prostate (BPEP)
Interventions
cystoscopic transurethral enucleation of the prostate using Holmium laser (Versa pulse 100W; Lumenis; Germany)
cystoscopic transurethral resection of the prostate using bipolar energy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- presence of a urethral stricture
- neurological disorder
- bladder cancer
- prostate cancer
- previous history of bladder neck surgery or TURP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University Hospitals
Cairo, 12222, Egypt
Related Publications (1)
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.
PMID: 32842769DERIVED
Study Officials
- STUDY DIRECTOR
enmar I Habib
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Urology
Study Record Dates
First Submitted
October 26, 2019
First Posted
October 29, 2019
Study Start
February 14, 2016
Primary Completion
May 1, 2019
Study Completion
June 10, 2019
Last Updated
October 29, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share