An interventional study of Endoscopic enucleation of the prostate in Lower Urinary Tract Symptoms, Lower Urinary Tract Obstructive Syndrome and Detrusor Underactivity, sponsored by EEPiDuDa Study Group. Not yet recruiting. Open to male participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.
Sponsored by EEPiDuDa Study Group · Not applicable, Interventional, and Treatment
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).
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.
31 studies on the registry are indexed under Urinary Bladder, Underactive; 6 are open to participants now.
This study's planned enrollment of 300 is above the median of 66 across 21 interventional studies indexed under Urinary Bladder, Underactive.
Browse Urinary Bladder, Underactive studies →This is the only study on the registry with EEPiDuDa Study Group as lead sponsor.
Compared within Urinary Bladder, Underactive, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lower Urinary Tract Symptoms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Endoscopic enucleation of the prostate in patients with DU/DA secondary to a non-neurogenic aetiology:
Exclusion Criteria:
Patients with urodynamically proven Detrusor Underactivity/Acontractility, who undergo endoscopic enucleation of the prostate (EEP).
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
Residual volume
Determined by sonography (ml)
Time frame: 2 months after surgery
Residual volume
Determined by sonography (ml)
Time frame: 1 year after surgery
International Prostate Symptom Score (IPSS)
Determined with a validated IPSS questionnaire (in the corresponding language)
Time frame: 2 months after surgery
International Prostate Symptom Score (IPSS)
Determined with a validated IPSS questionnaire (in the corresponding language)
Time frame: 1 year after surgery
Quality of life
Determined with a validated QoL questionnaire (in the corresponding language)
Time frame: 2 months after surgery
Quality of life
Determined with a validated QoL questionnaire (in the corresponding language)
Time frame: 1 year after surgery
Maximal flow rate (Qmax)
Determined using uroflowmetry (ml/s)
Time frame: 2 months after surgery
Maximal flow rate (Qmax)
Determined using uroflowmetry (ml/s)
Time frame: 1 year after surgery
Voided volume (VV)
Determined using uroflowmetry (ml)
Time frame: 2 months after surgery
Voided volume (VV)
Determined using uroflowmetry (ml)
Time frame: 1 year after surgery
Catheter - free rate
Is the patient still having an indwelling or suprapubic catheter?
Time frame: 2 months after surgery
Catheter - free rate
Is the patient still having an indwelling or suprapubic catheter?
Time frame: 1 year after surgery
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Urinary Bladder, Underactive →