EEP in Patients With Urodynamically Proven DU/DA

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorEEPiDuDa Study Group

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Endoscopic enucleation of the prostate

    Procedure/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

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: Endoscopic Enucleation of the ProstateOther 1 intervention

Trial outcomes

Primary outcomes

1

Residual volume

Determined by sonography (ml)

Time frame
2 months after surgery
2

Residual volume

Determined by sonography (ml)

Time frame
1 year after surgery
3

International Prostate Symptom Score (IPSS)

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

Time frame
2 months after surgery
4

International Prostate Symptom Score (IPSS)

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

Time frame
1 year after surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: