EEP in Patients With Urodynamically Proven DU/DA

Not Applicable

Not yet recruiting

• Conditions: Lower Urinary Tract Symptoms; Lower Urinary Tract Obstructive Syndrome; Detrusor Areflexia; Detrusor Underactivity; Prostatic Hyperplasia

• Registration Number: NCT06452927
• Lead Sponsor: EEPiDuDa Study Group

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

Study Timeline

• Study First Submitted: 2024-05-23
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Start: 2024-09
• Primary Completion: 2027-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 300

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 <100.
  • 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...)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Quality of life	1 year after surgery	Determined with a validated QoL questionnaire (in the corresponding language)
Voided volume (VV)	1 year after surgery	Determined using uroflowmetry (ml)
Maximal flow rate (Qmax)	1 year after surgery	Determined using uroflowmetry (ml/s)
Residual volume	1 year after surgery	Determined by sonography (ml)
International Prostate Symptom Score (IPSS)	1 year after surgery	Determined with a validated IPSS questionnaire (in the corresponding language)
Catheter - free rate	1 year after surgery	Is the patient still having an indwelling or suprapubic catheter?