Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.

February 8, 2026 updated by: Ain Shams University

Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.

Randomized Controlled Study Comparing Safety, Efficacy and Short Term Outcomes Of Bipolar Prostate Resection (BPR) Versus Diode Laser Ablation Versus Holmium Laser Enucleation Of Prostate Above 80 Grams With Minimum One Year Follow Up Duration.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

comparing three different techniques for treatment of prostatomegaly (BPH) bipolar resection of the prostate versus diode laser ablation of the prostate versus holmium laser enucleation monitoring preoperative data . intraoperative data , postoperative outcomes and long term outcomes within 1 year of the operation aiming to decide which technique has the superior hand over other regarding large size prostate above 80 grams

Study Type

Interventional

Enrollment (Estimated)

105

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 Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Refractory LUTS secondary to benign prostatic hyperplasia (BPH)
  • Acute retention secondary to BPH who failed medical treatment
  • Prostate size above 80 gm in Pelvi-Abdominal ultrasound or Trans-Rectal ultrasound

Exclusion Criteria:

  • Suspected Neurogenic bladder.
  • Suspected Prostatic adenocarcinoma (either by digital rectal examination or high PSA level)
  • Urinary bladder carcinoma
  • urethral stricture. previous bladder, urethral or prostate surgery.
  • Bleeding tendency.
  • Uncontrolled bleeding disorders.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: patient with prostate size above 80 grams for Bipolar resection
patient with prostate size above 80 grams
Procedure: bipolar resection of the prostate
bipolar resection of the prostate
Active Comparator: patient with prostate size above 80 grams for holmium laser enucleation
Procedure: holimum laser enucleation of the prostate
holimum laser enucleation of the prostate
Active Comparator: patient with prostate size above 80 grams for Diode laser ablation
Procedure: diode laser ablation of the prostate
diode laser ablation of the prostate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to catheter removal
Time Frame: within the first 1 week post-operatively
number of days to catheter removal post-operatively
within the first 1 week post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
removed prostatic tisuue
Time Frame: within the first month postoperatively
assessment of prostate size by Pelviabdominal ultrasound and wight of the removed prostatic tissues in grams
within the first month postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
post voiding residual
Time Frame: after the first month and 6th month postoperatively
post voiding urinary bladder volume by pelvic ultrasound in milliliters
after the first month and 6th month postoperatively
maximum flow rate
Time Frame: within the first and 6th month postoperatively
doing uroflometry and measure the maximum flow rate milliliter/second
within the first and 6th month postoperatively

Collaborators and Investigators

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

Sponsor

Ain Shams 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 (Estimated)

February 20, 2026

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

February 8, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 8, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Treatment modalities for BPH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All the parameters that are already mentioned in the study outcomes can be shared except for personal data of the patients (name , identification card numbers , address , phone Number)

IPD Sharing Time Frame

at the end of the study time (mostly after 1 year time)

IPD Sharing Access Criteria

Urologists , they can contact me on my mail address

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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