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RECRUITING
NCT07562386
NA

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

Sponsor: Sykehuset Innlandet HF

View on ClinicalTrials.gov

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).

Key Details

Gender

MALE

Age Range

Any - 80 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-09-25

Completion Date

2028-12

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

PROCEDURE

Transurethral resection of the prostate.

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

PROCEDURE

Bipolar enucleation of the prostate

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

Locations (2)

Innlandet Hospital Trust

Hamar, Norway

Akershus University Hospital

Lørenskog, Norway