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临床试验/NCT06452927
NCT06452927尚未招募不适用

Endoscopic Enucleation of the Prostate in Patients With Urodynamically Proven Detrusor Underactivity/Acontractility

EEPiDuDa Study Group0 个研究点目标入组 300 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
主要终点
Quality of life

研究概览

简要总结

The aim of this project is to create und evaluate a multicentral, retro-/prospective database for patients with urodynamically proven detrusor underactivity (DU) or acontractility (DA) secondary to a non-neurogenic aetiology, who undergo endoscopic, anatomic enucleation of the prostate (EEP).

详细描述

Background:

As one of the most common urological diseases benign prostatic hyperplasia (BPH) affects about ¾ of men in the seventh decade and is associated with major impact on quality of life (QoL) of patients as well as with substantial costs for the health care. For many patients suffering from lower urinary tract symptoms (LUTS) medical therapy, such as the use of α1-blockers, is initially successful, but surgical therapy becomes necessary when medical therapy fails and results / function remain unsatisfactory. Dependent on prostate volume (PV), different surgical techniques are available for treatment. For substantially enlarged glands open prostatectomy (OP) dominated as the oldest surgical procedure for many years. However, OP is associated with significant complications, and is currently recommended by the European Association of Urology (EAU) only in the absence of laser-assisted endoscopic enucleation options.

Among these patients, the presence of detrusor underactivity (DU) and detrusor acontractility (DA) represents a particularly challenging condition since no medical treatment is available. Due to this, efforts were focused on maximal surgical reduction of bladder outlet resistance to ensure efficient bladder emptying. The limited data on this topic showed promising outcomes for patients receiving holmium laser enucleation of the prostate (HoLEP). Therefore, the aim of this project is to evaluate the efficacy of EEP as a surgical approach for patients with DU/DA, regardless of PV or enucleation device/method.

Projekt objectives:

  • Creating a multicentral, retro-/prospective database for patients with urodynamically proven detrusor underactivity (DU) or acontractility (DA) secondary to a non-neurogenic aetiology, who undergo EEP.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Endoscopic enucleation of the prostate in patients with DU/DA secondary to a non-neurogenic aetiology:
  • Detrusor underactivity (DU) defined urodynamically as a bladder contractility index (BCI) of <
  • Detrusor acontractility (DA) defined urodynamically as the absence of a detrusor contraction despite filling to bladder capacity.

排除标准

  • Neurogenic aetiology for DU/DA (Parkinson, stroke…)
  • Other surgical approaches for the treatment of benign prostate hyperplasia (Aquaablation, open enucleation of the prostate, open prostatectomy, transurethral resection of the prostate...)

结局指标

主要结局

Quality of life

时间窗: 1 year after surgery

Determined with a validated QoL questionnaire (in the corresponding language)

Voided volume (VV)

时间窗: 1 year after surgery

Determined using uroflowmetry (ml)

Maximal flow rate (Qmax)

时间窗: 1 year after surgery

Determined using uroflowmetry (ml/s)

Residual volume

时间窗: 1 year after surgery

Determined by sonography (ml)

International Prostate Symptom Score (IPSS)

时间窗: 1 year after surgery

Determined with a validated IPSS questionnaire (in the corresponding language)

Catheter - free rate

时间窗: 1 year after surgery

Is the patient still having an indwelling or suprapubic catheter?

次要结局

未报告次要终点

研究者

发起方
EEPiDuDa Study Group
申办方类型
Network
责任方
Principal Investigator
主要研究者

Pawel Trotsenko

Dr. med. Dr. med. univ.

EEPiDuDa Study Group

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