NCT06452927

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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Sep 2024

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress42%
Sep 2024Sep 2028

First Submitted

Initial submission to the registry

May 23, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3 years

First QC Date

May 23, 2024

Last Update Submit

June 6, 2024

Conditions

Lower Urinary Tract SymptomsLower Urinary Tract Obstructive SyndromeDetrusor UnderactivityDetrusor AreflexiaProstatic Hyperplasia

Keywords

Endoscopic Enucleation of the ProstateBipoEPThuLEPDetrusor UnderactivityDetrusor AcontractilityHoLEPUrodynamicsPressure Flow Study

Outcome Measures

Primary Outcomes (12)

  • 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

Study Arms (1)

Endoscopic Enucleation of the Prostate

OTHER

Patients with urodynamically proven Detrusor Underactivity/Acontractility, who undergo endoscopic enucleation of the prostate (EEP).

Procedure: Endoscopic enucleation of the prostate

Interventions

Endoscopic enucleation of the prostatePROCEDURE

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

Endoscopic Enucleation of the Prostate

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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...)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 27585786BACKGROUND

  • 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.

    PMID: 20063164BACKGROUND

  • 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.

    PMID: 32286719BACKGROUND

  • 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.

    PMID: 35400612BACKGROUND

  • 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.

    PMID: 33625568BACKGROUND

  • 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.

    PMID: 24231217BACKGROUND

  • 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.

    PMID: 30582661BACKGROUND

  • 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.

    PMID: 33763730BACKGROUND

MeSH Terms

Conditions

Lower Urinary Tract SymptomsUrinary Bladder, UnderactiveProstatic Hyperplasia

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesProstatic DiseasesGenital Diseases, MaleGenital Diseases

Central Study Contacts

Pawel Trotsenko, Dr. med. Dr. med. univ.

CONTACT

004369919479989pawel.trotsenko@gmx.at

Thomas RW Herrmann, Prof.

CONTACT

thomas.herrmann@stgag.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med. Dr. med. univ.

Study Record Dates

First Submitted

May 23, 2024

First Posted

June 11, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2028

Last Updated

June 11, 2024

Record last verified: 2024-06