Outcome and Patient Experiences After Transurethral Resection and Bipolar Enucleation of the Prostate - a Multi-center, Randomized Controlled Trial.

NCT07562386 | Recruiting

• 1 other identifier: 150526
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

In this randomized controlled trial, we will evaluate if bipolar enucleation of the prostate (BEEP) is associated with better urinary voiding outcome than transurethral resection (TURP) in men with enlarged prostate referred to surgery. In addition we will investigate the association between symptom relief and the amount of removed tissue and if patients experience differ between the two methods. Finally, we will assess cost-effectiveness of BEEP compared to TURP. The main outcome for comparison of the two surgical methods is International Prostate Symptom Score (IPSS) assessed at 12-month follow-up. The primary outcome to assess patient experience is measured with the questionnaire Nordic Patients Experience Questionnaire (NORPEQ). Cost-effectiveness will be measured with incremental cost-effectiveness ratio (ICER).

Conditions

Lower Urinary Track Symptoms; Benign Prostate Obstruction (BPO)

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score (IPSS)

  The primary outcome is IPPS score. IPSS is recommended by the European Association of Urology to evaluate LUTS in men.

  IPSS will be assessed at baseline and after 12-month follow-up.

Study Arms (2)

Men with intermediate sized prostate and voiding problems treated with TURP.

ACTIVE COMPARATOR

Men with intermediate sized prostate and voiding problems are randomized to two different treatment modalities.

Procedure: Bipolar enucleation of the prostate

Men with intermediate sized prostate treated with BEEP.

ACTIVE COMPARATOR

Men with intermediate sized prostate and voiding problems are randomized to two different treatment modalities.

Procedure: Transurethral resection of the prostate.

Interventions

Transurethral resection of the prostate. PROCEDURE

The study compares two surgical treatments for voiding problems in men with enlarged prostate.

Men with intermediate sized prostate treated with BEEP.

Bipolar enucleation of the prostate PROCEDURE

Men with intermediate sized prostate and voiding problems are randomized to two different treatment modalities.

Men with intermediate sized prostate and voiding problems treated with TURP.

Eligibility Criteria

• Age: Up to 80 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men with prostate sizes between 30mL and 80mL on ultrasound, referred to BPH surgery, detrusor pressure ≥ 20 cmH2O on urodynamic tests, valid informed consent.

You may not qualify if:

• Previous surgery for BPH, men aged above 80 years old, severe comorbidity (not suitable for surgery), cognitive impairment, prostate cancer (palliative surgery), prior pelvic radiation therapy, anticoagulation/antiplatelet therapy can't be stopped.

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead

Study Sites (2)

Innlandet Hospital Trust

Hamar, 2318, Norway

RECRUITING

Akershus University Hospital

Lørenskog, Norway

NOT YET RECRUITING

MeSH Terms

Interventions

Transurethral Resection of Prostate

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Ola Christiansen, PhD

CONTACT

+4797747473; ola.christiansen@sykehuset-innlandet.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: May 1, 2026
• Study Start: September 25, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

NO (2)