HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH
Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial
1 other identifier
interventional
112
1 country
2
Brief Summary
To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (\> 80 gm)
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 Dec 2016
Longer than P75 for not_applicable
2 active sites
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
December 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 6, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2021
CompletedFirst Submitted
Initial submission to the registry
June 6, 2021
CompletedFirst Posted
Study publicly available on registry
June 22, 2021
CompletedJune 24, 2021
June 1, 2021
1.3 years
June 6, 2021
June 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
hemoglobin drop postoperatively (gm/dL)
change in hemoglobin concentration postoperatively vs preoperatively
within two hours after surgery
Secondary Outcomes (3)
operative duration in minutes
Time lapsed during surgery
Hospital stay
From time of randomisation up to last day of admission in hospital (in days) up to 30 days
blood transfusion
during surgery and hospitalisation up to 10 days
Other Outcomes (4)
complications (percent)
Three years
International prostate symptom score (IPSS)
Three years
Quality of life (QoL)
Three years
- +1 more other 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
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 with 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 (2)
Cairo University Hospitals
Cairo, 12222, Egypt
Theodor Bilharz research institute
Giza, 12111, Egypt
Study Officials
- STUDY DIRECTOR
Mamdouh A Roshdy, M.D
Theodor Bilharz research institue
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
Study Record Dates
First Submitted
June 6, 2021
First Posted
June 22, 2021
Study Start
December 4, 2016
Primary Completion
March 6, 2018
Study Completion
March 10, 2021
Last Updated
June 24, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share