跳至主要内容
临床试验/NCT07562386
NCT07562386招募中不适用

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

Sykehuset Innlandet HF2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
2
主要终点
International Prostate Symptom Score (IPSS)

研究概览

简要总结

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).

详细描述

Title:

Outcome and patient experiences after transurethral resection and bipolar enucleation of the prostate - a multi-center, randomized controlled trial.

Introduction:

In the present project we will evaluate if bipolar enucleation of the prostate (BEEP) is associated with better urinary voiding outcome than transurethral resection (TURP), and if the patients' experiences differ between these two methods. We will also investigate the association between symptom relief and the amount of tissue removed in the surgical procedure.

Lower urinary tract symptoms (LUTS) are prevalent in ageing men. LUTS encompasses several conditions such as for instance bladder dysfunction and pelvic pain. One major cause of LUTS is benign prostate hyperplasia (BPH) and secondary to this benign prostatic obstruction (BPO). About 50% of men in their 50s have BPH and in men aged above 70 years the prevalence is around 80%. The prostatic gland is located distally to the urinary bladder and surrounds the urethra. With increasing size, the prostate can cause bladder outflow obstruction and urinary voiding problems, most often weak urinary stream and increased residual urine. Residual urine, meaning incomplete emptying of the bladder, can lead to infections and urinary retention. Over time, it may cause damage to the urinary bladder muscle and the kidneys due to increased bladder pressure. LUTS caused by a hypertrophied prostate can be managed with lifestyle changes, medication or surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Men with prostate sizes between 30mL and 80mL on ultrasound, referred to BPH surgery, detrusor pressure ≥ 20 cmH2O on urodynamic tests, valid informed consent.

排除标准

  • 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.

研究组 & 干预措施

Men with intermediate sized prostate and voiding problems treated with TURP.

Active Comparator

Men with intermediate sized prostate and voiding problems are randomized to two different treatment modalities.

干预措施: Bipolar enucleation of the prostate (Procedure)

Men with intermediate sized prostate treated with BEEP.

Active Comparator

Men with intermediate sized prostate and voiding problems are randomized to two different treatment modalities.

干预措施: Transurethral resection of the prostate. (Procedure)

结局指标

主要结局

International Prostate Symptom Score (IPSS)

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

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Outcome and Patient Experiences After Transurethral... | 临床试验