Comparing bipolar enucleation versus transurethral resection for enlarged prostate outcomes and patient experience
Official title: Outcome and Patient Experiences After Transurethral Resection and Bipolar Enucleation of the Prostate - a Multi-center, Randomized Controlled Trial.
Run by Sykehuset Innlandet HF · NCT07562386 · Data updated 2026-11-12
This trial will test whether bipolar enucleation or standard transurethral resection gives better urinary symptoms, patient experience, and value for men with enlarged prostates who are referred for surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 80 Years |
| Sex | Men only |
| Enrollment | 120 (estimated) |
| Sponsor | Sykehuset Innlandet HF Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Hamar and 1 other locations) |
| Status | Recruiting |
| Started | September 25, 2025 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07562386 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men under 80 years with benign prostatic obstruction, prostate size 30–80 mL on ultrasound, detrusor pressure ≥20 cmH2O on urodynamics, referred for BPH surgery and able to give informed consent.
✕Probably not a fit
Patients unlikely to benefit include those over 80, with prior BPH surgery, prostate cancer requiring different management, severe comorbidity making them unfit for surgery, prior pelvic radiation, or who cannot safely stop anticoagulation/antiplatelet therapy.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In a multicenter randomized comparison, men with benign prostatic obstruction and prostate volumes of 30–80 mL will be randomly assigned to bipolar enucleation of the prostate (BEEP) or conventional transurethral resection of the prostate (TURP). The main clinical outcome is change in International Prostate Symptom Score (IPSS) at 12 months, and patient experience will be measured using the Nordic Patients Experience Questionnaire (NORPEQ). The protocol also examines the relationship between symptom relief and tissue volume removed and includes a cost-effectiveness analysis using incremental cost-effectiveness ratio (ICER). Recruitment occurs at Norwegian centers (Innlandet Hospital Trust and Akershus University Hospital) with standard perioperative follow-up procedures.
Why it matters
Potential benefit: If successful, the trial could identify a surgical approach that gives better symptom relief, improves patient experience, and may be more cost-effective than current standard TURP.
How similar studies have gone: Previous studies of enucleation techniques (including holmium laser enucleation and bipolar enucleation) have often shown equal or improved urinary outcomes and tissue removal compared with TURP, but large multicenter randomized comparisons specifically of bipolar enucleation versus TURP are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Men with prostate sizes between 30mL and 80mL on ultrasound, referred to BPH surgery, detrusor pressure ≥ 20 cmH2O on urodynamic tests, valid informed consent. Exclusion Criteria: 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.
Where it's running
-
Innlandet Hospital Trust
Hamar, Norway Recruiting -
Akershus University Hospital
Lørenskog, Norway Not yet recruiting
Study contacts
- Study coordinator: Ola Christiansen, PhD
- Email: ola.christiansen@sykehuset-innlandet.no
- Phone: +4797747473
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.