Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study (BPH)

June 25, 2019 updated by: Mohammed Said ElSheemy, Cairo University

Holmium Laser Enucleation Versus Bipolar Plasmakinetic Enucleation of a Large Volume Benign Prostatic Hyperplasia: a Randomised Controlled Study

To compare bipolar plasmakinetic enucleation 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 plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (>80gm).

Study Type

Interventional

Enrollment (Actual)

64

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

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

36 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 ≥ 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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: HoLEP holmium laser enucleation of the prostate
holmium laser enucleation of the prostate
Procedure: Holmium laser enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)
Other Names:
  • HoLEP
Active Comparator: BPEP bipolar plasmakinetic enucleation of the prostate
bipolar plasmakinetic enucleation of the prostate
Procedure: Bipolar plasma kinetic enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)
Other Names:
  • BPEP

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 time
Time Frame: during surgery
operative time in minutes
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complications (%)
Time Frame: one year
intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.
one year
urine flow
Time Frame: one year
Qmax (ml/s),
one year
post-voiding residual urine
Time Frame: one year
postvoiding residual urine (ml)
one year
International prostate symptom score (IPSS)
Time Frame: one year
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
one year
Quality of life (QoL) section of International prostate symptom score (IPSS)
Time Frame: one year
one question scored from 0 up to 6 (6 is worst)
one year

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: enmar I Habib, Prof., 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.

General Publications

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)

November 1, 2016

Primary Completion (Actual)

February 14, 2018

Study Completion (Actual)

March 8, 2019

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

June 27, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 61647

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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