EEP in Patients With Urodynamically Proven DU/DA

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Lower Urinary Tract Obstructive Syndrome; Detrusor Underactivity; Detrusor Areflexia
• Intervention / Treatment: Procedure: Endoscopic enucleation of the prostate

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pawel Trotsenko, Dr. med. Dr. med. univ.; Phone Number: 004369919479989; Email: pawel.trotsenko@gmx.at
• Study Contact Backup: Name: Thomas RW Herrmann, Prof.; Email: thomas.herrmann@stgag.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Endoscopic Enucleation of the Prostate; Patients with urodynamically proven Detrusor Underactivity/Acontractility, who undergo endoscopic enucleation of the prostate (EEP).	Procedure: Endoscopic 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual volume	Determined by sonography (ml)	2 months after surgery
Residual volume	Determined by sonography (ml)	1 year after surgery
International Prostate Symptom Score (IPSS)	Determined with a validated IPSS questionnaire (in the corresponding language)	2 months after surgery
International Prostate Symptom Score (IPSS)	Determined with a validated IPSS questionnaire (in the corresponding language)	1 year after surgery
Quality of life	Determined with a validated QoL questionnaire (in the corresponding language)	2 months after surgery
Quality of life	Determined with a validated QoL questionnaire (in the corresponding language)	1 year after surgery
Maximal flow rate (Qmax)	Determined using uroflowmetry (ml/s)	2 months after surgery
Maximal flow rate (Qmax)	Determined using uroflowmetry (ml/s)	1 year after surgery
Voided volume (VV)	Determined using uroflowmetry (ml)	2 months after surgery
Voided volume (VV)	Determined using uroflowmetry (ml)	1 year after surgery
Catheter - free rate	Is the patient still having an indwelling or suprapubic catheter?	2 months after surgery
Catheter - free rate	Is the patient still having an indwelling or suprapubic catheter?	1 year after surgery

Collaborators and Investigators

• Sponsor: EEPiDuDa Study Group

Publications and helpful links

General Publications

• Herrmann TR. Enucleation is enucleation is enucleation is enucleation. World J Urol. 2016 Oct;34(10):1353-5. doi: 10.1007/s00345-016-1922-3. Epub 2016 Sep 1.
• Herrmann TR, Bach T, Imkamp F, Georgiou A, Burchardt M, Oelke M, Gross AJ. Thulium laser enucleation of the prostate (ThuLEP): transurethral anatomical prostatectomy with laser support. Introduction of a novel technique for the treatment of benign prostatic obstruction. World J Urol. 2010 Feb;28(1):45-51. doi: 10.1007/s00345-009-0503-0.
• Herrmann TRW, Wolters M. Transurethral anatomical enucleation of the prostate with Tm:YAG support (ThuLEP): Evolution and variations of the technique. The inventors' perspective. Andrologia. 2020 Sep;52(8):e13587. doi: 10.1111/and.13587. Epub 2020 Apr 14.
• Miernik A, Roehrborn CG. Benign Prostatic Hyperplasia Treatment On Its Way to Precision Medicine: Dream or Reality? Eur Urol Focus. 2022 Mar;8(2):363-364. doi: 10.1016/j.euf.2022.03.023. Epub 2022 Apr 7. No abstract available.
• Gomez-Sancha F. The constant search for the greater good: evolving from TURP to anatomic enucleation of the prostate is a safe bet. World J Urol. 2021 Jul;39(7):2401-2406. doi: 10.1007/s00345-021-03637-1. Epub 2021 Feb 24.
• Mitchell CR, Mynderse LA, Lightner DJ, Husmann DA, Krambeck AE. Efficacy of holmium laser enucleation of the prostate in patients with non-neurogenic impaired bladder contractility: results of a prospective trial. Urology. 2014 Feb;83(2):428-32. doi: 10.1016/j.urology.2013.09.035. Epub 2013 Nov 12.
• Cho MC, Yoo S, Park J, Cho SY, Son H, Oh SJ, Paick JS. Effect of preoperative detrusor underactivity on long-term surgical outcomes of photovaporization and holmium laser enucleation in men with benign prostatic hyperplasia: a lesson from 5-year serial follow-up data. BJU Int. 2019 May;123(5A):E34-E42. doi: 10.1111/bju.14661. Epub 2019 Jan 27.
• Aho T, Finch W, Jefferson P, Suraparaju L, Georgiades F. HoLEP for acute and non-neurogenic chronic urinary retention: how effective is it? World J Urol. 2021 Jul;39(7):2355-2361. doi: 10.1007/s00345-021-03657-x. Epub 2021 Mar 24.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 6, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Urodynamics; HoLEP; Endoscopic Enucleation of the Prostate; ThuLEP; BipoEP; Detrusor Underactivity; Detrusor Acontractility; Pressure Flow Study
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Urological Manifestations; Neurologic Manifestations; Prostatic Diseases; Dyskinesias; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms; Hypokinesia; Urinary Bladder, Underactive
• Other Study ID Numbers: EEPiDuDa 1.0 - 2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No