HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH

June 21, 2021 updated by: Mohammed Said ElSheemy, Cairo University

Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial

To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm)

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 symptomatic large BPH (> 80 gm)

Study Type

Interventional

Enrollment (Actual)

112

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

  • Egypt
      • Cairo, Egypt, 12222
        • Cairo University hospitals
      • Giza, Egypt, 12111
        • Theodor Bilharz Research Institute

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 with 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 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)
Procedure: holmium laser enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using Holmium laser
Other Names:
  • HoLEP
ACTIVE_COMPARATOR: bipolar resection of the prostate
bipolar resection of the prostate (BPEP)
Procedure: Bipolar resection of the prostate
cystoscopic transurethral resection of the prostate using bipolar energy
Other Names:
  • BPRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin drop postoperatively (gm/dL)
Time Frame: within two hours after surgery
change in hemoglobin concentration postoperatively vs preoperatively
within two hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative duration in minutes
Time Frame: Time lapsed during surgery
operative duration
Time lapsed during surgery
Hospital stay
Time Frame: From time of randomisation up to last day of admission in hospital (in days) up to 30 days
Hospitalisation starting from day of surgery till the day of discharge from Hospital in days
From time of randomisation up to last day of admission in hospital (in days) up to 30 days
blood transfusion
Time Frame: during surgery and hospitalisation up to 10 days
rate of blood transfusion
during surgery and hospitalisation up to 10 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications (percent)
Time Frame: Three years
All complications
Three years
International prostate symptom score (IPSS)
Time Frame: Three 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
Three years
Quality of life (QoL)
Time Frame: Three years
section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)
Three years
flowmetry
Time Frame: Three years
rate of flow (ml urine) per second
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Collaborators

Theodor Bilharz Research Institute

Investigators

  • Study Director: Mamdouh A Roshdy, M.D, Theodor Bilharz research institue

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)

December 4, 2016

Primary Completion (ACTUAL)

March 6, 2018

Study Completion (ACTUAL)

March 10, 2021

Study Registration Dates

First Submitted

June 6, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (ACTUAL)

June 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 24, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC-TBRI-PT563

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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