Skip to main content
Clinical Trials/NCT06452927
NCT06452927
Not Yet Recruiting
N/A

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

EEPiDuDa Study Group0 sites300 target enrollmentSeptember 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lower Urinary Tract Symptoms
Sponsor
EEPiDuDa Study Group
Enrollment
300
Primary Endpoint
Quality of life
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

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).

Detailed Description

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. * Phase 1: retrospective (patients with urodynamically proven, meeting inclusion criteria, and postoperative outcome according to material and methods from existing patient chart. * Phase 2: prospective capture of patient's data according to material and methods. * Estimated cohort-size: based on available data set. * Powering of phase 2 based on the retrospective cohort. * Evaluating EEP as a surgical approach for patients with DU/DA, regardless of PV or energy source for endoscopic EEP. * Enhancing importance of preoperative urodynamics as a tool for precision medicine in LUTS

Registry
clinicaltrials.gov
Start Date
September 2024
End Date
September 2028
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
EEPiDuDa Study Group
Responsible Party
Principal Investigator
Principal Investigator

Pawel Trotsenko

Dr. med. Dr. med. univ.

EEPiDuDa Study Group

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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...)

Outcomes

Primary Outcomes

Quality of life

Time Frame: 1 year after surgery

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

Voided volume (VV)

Time Frame: 1 year after surgery

Determined using uroflowmetry (ml)

Maximal flow rate (Qmax)

Time Frame: 1 year after surgery

Determined using uroflowmetry (ml/s)

Residual volume

Time Frame: 1 year after surgery

Determined by sonography (ml)

International Prostate Symptom Score (IPSS)

Time Frame: 1 year after surgery

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

Catheter - free rate

Time Frame: 1 year after surgery

Is the patient still having an indwelling or suprapubic catheter?

Similar Trials