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EEP in Patients With Urodynamically Proven DU/DA

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06452927
Enrollment
300
Registered
2024-06-11
Start date
2024-09-30
Completion date
2028-09-30
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Detrusor Areflexia, Detrusor Underactivity, Lower Urinary Tract Obstructive Syndrome, Lower Urinary Tract Symptoms, Prostatic Hyperplasia

Keywords

Endoscopic Enucleation of the Prostate, BipoEP, ThuLEP, Detrusor Underactivity, Detrusor Acontractility, HoLEP, Urodynamics, Pressure Flow Study

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

Interventions

PROCEDUREEndoscopic enucleation of the prostate

Endoscopic enucleation of the prostate, regardless of energy source. Also see: * Enucleation is enucleation is enucleation is enucleation * PMID: 27585786 DOI: 10.1007/s00345-016-1922-3

Sponsors

EEPiDuDa Study Group
Lead SponsorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frameDescription
Residual volume2 months after surgeryDetermined by sonography (ml)
International Prostate Symptom Score (IPSS)2 months after surgeryDetermined with a validated IPSS questionnaire (in the corresponding language)
Quality of life2 months after surgeryDetermined with a validated QoL questionnaire (in the corresponding language)
Maximal flow rate (Qmax)2 months after surgeryDetermined using uroflowmetry (ml/s)
Voided volume (VV)2 months after surgeryDetermined using uroflowmetry (ml)
Catheter - free rate2 months after surgeryIs the patient still having an indwelling or suprapubic catheter?

Contacts

Primary ContactPawel Trotsenko, Dr. med. Dr. med. univ.
pawel.trotsenko@gmx.at004369919479989
Backup ContactThomas RW Herrmann, Prof.
thomas.herrmann@stgag.ch

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026