Clinical trial NCT06452927: EEP in Patients With Urodynamically Proven DU/DA
Official title: Endoscopic Enucleation of the Prostate in Patients With Urodynamically Proven Detrusor Underactivity/Acontractility
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Lower Urinary Tract Obstructive Syndrome
Detrusor Underactivity
Detrusor Areflexia
Prostatic Hyperplasia
Keywords: Endoscopic Enucleation of the Prostate
BipoEP
ThuLEP
Detrusor Underactivity
Detrusor Acontractility
HoLEP
Urodynamics
Pressure Flow Study
Lead sponsor: EEPiDuDa Study Group
Sponsor class: NETWORK
First posted: 2024-06-11
Enrollment: 300
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 \<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...)

Primary outcomes:
measure: Residual volume
timeFrame: 2 months after surgery
measure: Residual volume
timeFrame: 1 year after surgery
measure: International Prostate Symptom Score (IPSS)
timeFrame: 2 months after surgery
measure: International Prostate Symptom Score (IPSS)
timeFrame: 1 year after surgery
measure: Quality of life
timeFrame: 2 months after surgery
measure: Quality of life
timeFrame: 1 year after surgery
measure: Maximal flow rate (Qmax)
timeFrame: 2 months after surgery
measure: Maximal flow rate (Qmax)
timeFrame: 1 year after surgery
measure: Voided volume (VV)
timeFrame: 2 months after surgery
measure: Voided volume (VV)
timeFrame: 1 year after surgery
measure: Catheter - free rate
timeFrame: 2 months after surgery
measure: Catheter - free rate
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.