Actively Recruiting

Phase Not Applicable
Age: 0 - 80Years
MALE
NCT07562386

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

Led by Sykehuset Innlandet HF · Updated on 2026-05-01

120

Participants Needed

2

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 0 - 80Years
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Men with prostate sizes between 30mL and 80mL on ultrasound
  • Referred to surgery for benign prostate hyperplasia (BPH)
  • Detrusor pressure 6 20 cmH2O on urodynamic tests
  • Provided valid informed consent
Not Eligible

You will not qualify if you...

  • Previous surgery for benign prostate hyperplasia (BPH)
  • Men older than 80 years
  • Severe health problems making surgery unsafe
  • Cognitive impairment
  • Prostate cancer treated with palliative surgery
  • Prior pelvic radiation therapy
  • Anticoagulation or antiplatelet therapy that cannot be stopped

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Innlandet Hospital Trust

Hamar, Norway, 2318

Actively Recruiting

2

Akershus University Hospital

Lørenskog, Norway

Not Yet Recruiting

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Research Team

O

Ola Christiansen, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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