Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study
BPH
Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study
1 other identifier
interventional
64
1 country
1
Brief Summary
To compare bipolar plasmakinetic enucleation 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 P50-P75 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2019
CompletedFirst Submitted
Initial submission to the registry
June 14, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedJune 27, 2019
June 1, 2019
1.3 years
June 14, 2019
June 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
hemoglobin drop postoperatively (gm/dL)
difference in hemoglobin concentration postoperatively vs preoperatively
Immediate postoperatively
operative time
operative time in minutes
during surgery
Secondary Outcomes (5)
complications (%)
one year
urine flow
one year
post-voiding residual urine
one year
International prostate symptom score (IPSS)
one year
Quality of life (QoL) section of International prostate symptom score (IPSS)
one year
Study Arms (2)
HoLEP holmium laser enucleation of the prostate
ACTIVE COMPARATORholmium laser enucleation of the prostate
BPEP bipolar plasmakinetic enucleation of the prostate
ACTIVE COMPARATORbipolar plasmakinetic enucleation of the prostate
Interventions
cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)
cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)
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 ≥ 80 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
- Theodor Bilharz Research Institutecollaborator
Study Sites (1)
Cairo University Hospitals
Cairo, 12222, Egypt
Related Publications (1)
Habib E, Ayman LM, ElSheemy MS, El-Feel AS, Elkhouly A, Nour HH, Badawy MH, Elbaz AG, Roshdy MA. Holmium Laser Enucleation vs Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: A Randomized Controlled Trial. J Endourol. 2020 Mar;34(3):330-338. doi: 10.1089/end.2019.0707. Epub 2020 Feb 28.
PMID: 31813283DERIVED
Study Officials
- STUDY DIRECTOR
enmar I Habib, Prof.
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
June 14, 2019
First Posted
June 26, 2019
Study Start
November 1, 2016
Primary Completion
February 14, 2018
Study Completion
March 8, 2019
Last Updated
June 27, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share