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.

NCT07410390 | Not Yet Recruiting DMC

• 1 other identifier: Treatment modalities for BPH
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia With Outflow Obstruction

Outcome Measures

Primary Outcomes (1)

• time to catheter removal

  number of days to catheter removal post-operatively

  within the first 1 week post-operatively

Secondary Outcomes (1)

• removed prostatic tisuue

  within the first month postoperatively

Other Outcomes (2)

• post voiding residual

  after the first month and 6th month postoperatively

• maximum flow rate

  within the first and 6th month postoperatively

Study Arms (3)

patient with prostate size above 80 grams for Bipolar resection

ACTIVE COMPARATOR

patient with prostate size above 80 grams

Procedure: bipolar resection of the prostate

patient with prostate size above 80 grams for holmium laser enucleation

ACTIVE COMPARATOR

patient with prostate size above 80 grams for holmium laser enucleation

Procedure: holimum laser enucleation of the prostate

patient with prostate size above 80 grams for Diode laser ablation

ACTIVE COMPARATOR

patient with prostate size above 80 grams for Diode laser ablation

Procedure: diode laser ablation of the prostate

Interventions

holimum laser enucleation of the prostate PROCEDURE

holimum laser enucleation of the prostate

patient with prostate size above 80 grams for holmium laser enucleation

diode laser ablation of the prostate PROCEDURE

diode laser ablation of the prostate

patient with prostate size above 80 grams for Diode laser ablation

bipolar resection of the prostate PROCEDURE

bipolar resection of the prostate

patient with prostate size above 80 grams for Bipolar resection

Eligibility Criteria

• Age: 55 Years - 85 Years
• Gender Eligibility Details: males are only included in the study as we study different techniques for treatment of enlarged prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (2)

• Elshal AM, Soltan M, El-Tabey NA, Laymon M, Nabeeh A. Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes. BJU Int. 2020 Dec;126(6):731-738. doi: 10.1111/bju.15161. Epub 2020 Sep 30.

  PMID: 32633020 RESULT

• Blanco Fernandez R, Gonzalez Rodriguez I, Fernandez-Pello Montes S, Sanchez Verdes P, Miranda Garcia P, Suarez Sal PJ, Alonso Calvar L, Rodriguez Villamil L. Holmium laser enucleation of the prostate (HoLEP) as same-day surgery: A safe and feasible option. Actas Urol Esp (Engl Ed). 2023 Sep;47(7):457-461. doi: 10.1016/j.acuroe.2023.05.006. Epub 2023 Jun 25. English, Spanish.

  PMID: 37369301 RESULT

Central Study Contacts

amr ahmed said elsawy, urology specialist

CONTACT

01222543421; amr.elasawy@med.asu.edu.eg

amr said elsawy, urologist

CONTACT

01096907834; amrsaideldoc2020@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: February 13, 2026
• Study Start: February 20, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: at the end of the study time (mostly after 1 year time)
• Access Criteria: Urologists , they can contact me on my mail address