AzTrials
AzTrials

Lower Urinary Tract SymptomsNCT06452927

EEP in Patients With Urodynamically Proven DU/DA

A study testing Endoscopic enucleation of the prostate in people with Lower Urinary Tract Symptoms and Lower Urinary Tract Obstructive Syndrome, run by EEPiDuDa Study Group.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 40 years and older, men only
What is being tested?
Endoscopic enucleation of the prostate
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
Sep 2024to Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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...)

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

004369919479989

pawel.trotsenko@gmx.at

Thomas RW Herrmann, Prof. contact

thomas.herrmann@stgag.ch

About this study

Official title: 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).

Read the 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
Being tested
Endoscopic enucleation of the prostate
Keywords
Endoscopic Enucleation of the Prostate, BipoEP, ThuLEP, Detrusor Underactivity, Detrusor Acontractility, HoLEP, Urodynamics, Pressure Flow Study
Medical subject headings
Lower Urinary Tract Symptoms, Urinary Bladder, Underactive, Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endoscopic enucleation of the prostateProcedure or surgery

    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
Study groups in NCT06452927
Study groupRoleWhat they receive
Endoscopic Enucleation of the ProstateOtherPatients with urodynamically proven Detrusor Underactivity/Acontractility, who undergo endoscopic enucleation of the prostate (EEP).
Receives: Procedure: Endoscopic enucleation of the prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Residual volume

    Determined by sonography (ml)

    Measured: 2 months after surgery

  2. Residual volume

    Determined by sonography (ml)

    Measured: 1 year after surgery

  3. International Prostate Symptom Score (IPSS)

    Determined with a validated IPSS questionnaire (in the corresponding language)

    Measured: 2 months after surgery

  4. International Prostate Symptom Score (IPSS)

    Determined with a validated IPSS questionnaire (in the corresponding language)

    Measured: 1 year after surgery

  5. Quality of life

    Determined with a validated QoL questionnaire (in the corresponding language)

    Measured: 2 months after surgery

  6. Quality of life

    Determined with a validated QoL questionnaire (in the corresponding language)

    Measured: 1 year after surgery

  7. Maximal flow rate (Qmax)

    Determined using uroflowmetry (ml/s)

    Measured: 2 months after surgery

  8. Maximal flow rate (Qmax)

    Determined using uroflowmetry (ml/s)

    Measured: 1 year after surgery

  9. Voided volume (VV)

    Determined using uroflowmetry (ml)

    Measured: 2 months after surgery

  10. Voided volume (VV)

    Determined using uroflowmetry (ml)

    Measured: 1 year after surgery

  11. Catheter - free rate

    Is the patient still having an indwelling or suprapubic catheter?

    Measured: 2 months after surgery

  12. Catheter - free rate

    Is the patient still having an indwelling or suprapubic catheter?

    Measured: 1 year after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study startSep 2024 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452927
Sponsor's protocol ID
EEPiDuDa 1.0 - 2024
Status last verified
Jun 2024
First submitted
23 May 2024
Last updated
11 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 27585786

  • 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.

    PubMed 20063164

  • 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.

    PubMed 32286719

  • 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.

    PubMed 35400612

  • 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.

    PubMed 33625568

  • 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.

    PubMed 24231217

  • 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.

    PubMed 30582661

  • 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.

    PubMed 33763730

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic enucleation of the prostate in people with Lower Urinary Tract Symptoms and Lower Urinary Tract Obstructive Syndrome, run by EEPiDuDa Study Group.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pawel Trotsenko, Dr. med. Dr. med. univ. (004369919479989, pawel.trotsenko@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Residual volume (time frame: 2 months after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452927, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in