Comparing bipolar enucleation versus transurethral resection for enlarged prostate outcomes and patient experience
Outcome and Patient Experiences After Transurethral Resection and Bipolar Enucleation of the Prostate - a Multi-center, Randomized Controlled Trial.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 80 Years |
| Sex | Male |
| Sponsor | Sykehuset Innlandet HF Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Hamar and 1 other locations) |
| Trial ID | NCT07562386 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hamar and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.