EEP in Patients With Urodynamically Proven DU/DA

Lower Urinary Tract Symptoms Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Detrusor Underactivity
• Hyperplasia
• Hypokinesia
• Lower Urinary Tract Obstructive Syndrome
• Lower Urinary Tract Symptoms
• Prostatic Hyperplasia
• Urinary Bladder, Underactive

• NCT number: NCT06452927
• Study type: Interventional
• Source: EEPiDuDa Study Group
• Contact: Pawel Trotsenko, Dr. med. Dr. med. univ.
• Phone: 004369919479989
• Email: pawel.trotsenko@gmx.at
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Completion date: September 2028