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

ConditionsLower Urinary Track Symptoms Benign Prostate Obstruction (BPO)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexMale

AgeUp to 80

SponsorSykehuset Innlandet HF

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Transurethral resection of the prostate.
Procedure/Surgery
The study compares two surgical treatments for voiding problems in men with enlarged prostate.
Bipolar enucleation of the prostate
Procedure/Surgery
Men with intermediate sized prostate and voiding problems are randomized to two different treatment modalities.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Men with intermediate sized prostate and voiding problems treated with TURP.Active comparator 1 intervention

Group B: Men with intermediate sized prostate treated with BEEP.Active comparator 1 intervention

Trial outcomes

Primary outcomes

International Prostate Symptom Score (IPSS)

The primary outcome is IPPS score. IPSS is recommended by the European Association of Urology to evaluate LUTS in men.

Time frame

IPSS will be assessed at baseline and after 12-month follow-up.

Sponsors and contacts

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Sykehuset Innlandet HF

Lead sponsor

Source ClinicalTrials.gov

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