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NCT Number: NCT06452927

EEP in Patients With Urodynamically Proven DU/DA

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).

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Key information

Conditions

Lower Urinary Tract Symptoms Detrusor Areflexia Detrusor Underactivity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Lower Urinary Tract Obstructive Syndrome Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Underactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...)

Treatment and study plan

Endoscopic enucleation of the prostate

Procedure

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

Primary outcomes

  1. Residual volume

    Time frame: 2 months after surgery

    Determined by sonography (ml)

  2. Residual volume

    Time frame: 1 year after surgery

    Determined by sonography (ml)

  3. International Prostate Symptom Score (IPSS)

    Time frame: 2 months after surgery

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

  4. International Prostate Symptom Score (IPSS)

    Time frame: 1 year after surgery

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

  5. Quality of life

    Time frame: 2 months after surgery

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

  6. Quality of life

    Time frame: 1 year after surgery

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

  7. Maximal flow rate (Qmax)

    Time frame: 2 months after surgery

    Determined using uroflowmetry (ml/s)

  8. Maximal flow rate (Qmax)

    Time frame: 1 year after surgery

    Determined using uroflowmetry (ml/s)

  9. Voided volume (VV)

    Time frame: 2 months after surgery

    Determined using uroflowmetry (ml)

  10. Voided volume (VV)

    Time frame: 1 year after surgery

    Determined using uroflowmetry (ml)

  11. Catheter - free rate

    Time frame: 2 months after surgery

    Is the patient still having an indwelling or suprapubic catheter?

  12. Catheter - free rate

    Time frame: 1 year after surgery

    Is the patient still having an indwelling or suprapubic catheter?

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

004369919479989

Thomas RW Herrmann, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

EEPiDuDa Study Group

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jun 11, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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