- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04143399
HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial
October 26, 2019 updated by: Mohammed Said ElSheemy, Cairo University
Holmium Laser Enucleation vs Bipolar Resection of a Large Volume BPH: a Randomised Controlled Study
To compare bipolar resection versus holmium laser enucleation for management of large BPH.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (> 75 gm).
Study Type
Interventional
Enrollment (Actual)
145
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 12222
- Cairo University Hospitals
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: holmium laser enucleation of the prostate
holmium laser enucleation of the prostate (HoLEP)
|
cystoscopic transurethral enucleation of the prostate using Holmium laser (Versa pulse 100W; Lumenis; Germany)
Other Names:
|
ACTIVE_COMPARATOR: bipolar resection of the prostate
bipolar resection of the prostate (BPEP)
|
cystoscopic transurethral resection of the prostate using bipolar energy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hemoglobin drop postoperatively (gm/dL)
Time Frame: Immediate postoperatively
|
difference in hemoglobin concentration postoperatively vs preoperatively
|
Immediate postoperatively
|
operative duration in minutes
Time Frame: during surgery
|
operative duration
|
during surgery
|
Hospital stay in days
Time Frame: immediately after surgery
|
Hospital stay
|
immediately after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
complications (%)
Time Frame: Two years
|
intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.
|
Two years
|
urine flow
Time Frame: Two years
|
Qmax (ml/s),
|
Two years
|
post-voiding residual urine
Time Frame: Two years
|
postvoiding residual urine (ml)
|
Two years
|
International prostate symptom score (IPSS)
Time Frame: 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
|
Two years
|
Quality of life (QoL)
Time Frame: Two years
|
section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)
|
Two years
|
Catheter duration
Time Frame: immediate postoperatively
|
Catheter duration in hours
|
immediate postoperatively
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: enmar I Habib, Cairo University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 14, 2016
Primary Completion (ACTUAL)
May 1, 2019
Study Completion (ACTUAL)
June 10, 2019
Study Registration Dates
First Submitted
October 26, 2019
First Submitted That Met QC Criteria
October 26, 2019
First Posted (ACTUAL)
October 29, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 29, 2019
Last Update Submitted That Met QC Criteria
October 26, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 62513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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