Actively Recruiting
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether bipolar enucleation of the prostate (BEEP) leads to better urinary voiding outcomes than transurethral resection of the prostate (TURP) in men with enlarged prostates experiencing voiding problems. This multi-center randomized controlled trial focuses on men with prostate sizes between 30mL and 80mL who have lower urinary tract symptoms caused by benign prostate obstruction. The study also explores how symptom relief relates to the amount of tissue removed, differences in patient experiences between the two procedures, and the cost-effectiveness of BEEP compared to TURP. Participants will be randomly assigned to receive either TURP or BEEP, both transurethral surgical procedures performed to relieve urinary symptoms by removing prostate tissue. TURP involves removing central prostatic tissue starting from the bladder neck downwards, while BEEP removes tissue starting in the peripheral zone towards the bladder. Outcomes will be assessed at baseline and 12 months after surgery, with additional patient experience questionnaires at 3 and 12 months. Both procedures are performed under standard surgical care by experienced urologists. During the study, participants will complete the International Prostate Symptom Score (IPSS) to measure urinary symptoms and the Nordic Patients Experience Questionnaire (NORPEQ) to evaluate patient experience. Additional assessments include urinary flow measurements, residual urine volume, complications, catheter use, quality of life questionnaires, sexual function, and health care resource use. Cost-effectiveness will be analyzed using quality-adjusted life years (QALYs) over the 12-month follow-up. The study aims to enroll 120 men, with follow-up visits and data collection managed through electronic systems over one year.
CONDITIONS
Brief Title
Outcome and Patient Experiences After Transurethral Resection and Bipolar Enucleation of the Prostate - a Multi-center, Randomized Controlled Trial.
Who Can Participate
Eligibility Criteria
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 of 20 cmH2O or higher on urodynamic tests
- Able and willing to provide valid informed consent
You will not qualify if you...
- Previous surgery for benign prostate hyperplasia (BPH)
- Men older than 80 years
- Severe health conditions making surgery unsuitable
- Cognitive impairment
- Prostate cancer requiring palliative surgery
- Prior pelvic radiation therapy
- Use of anticoagulation or antiplatelet therapy that cannot be stopped
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with hospital stay
Participants undergo surgery for benign prostate hyperplasia with either transurethral resection of the prostate (TURP) or bipolar enucleation of the prostate (BEEP).
1 surgical visit and hospital stay
Duration - 12 months
Participants are followed for 12 months after surgery to assess symptom relief, patient experiences, and any adverse effects.
Assessments at baseline, 3 months, and 12 months post-surgery
Trial Site Locations
Total: 2 locations
1
Innlandet Hospital Trust
Hamar, Norway, 2318
Actively Recruiting
2
Akershus University Hospital
Lørenskog, Norway
Not Yet Recruiting
Research Team
O
Ola Christiansen, PhD
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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