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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452927
• Other study ID #: EEPiDuDa 1.0 - 2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: September 2028

Study information

• Verified date: June 2024
• Source: EEPiDuDa Study Group
• Contact: Pawel Trotsenko, Dr. med. Dr. med. univ.
• Phone: 004369919479989
• Email: pawel.trotsenko[@]gmx.at
• Is FDA regulated: No
• Study type: Interventional

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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: September 2028
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EEPiDuDa Study Group

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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