rodynamic effect of Prostate Artery Embolization for lower urinary tract symptoms due to benign prostate hyperplasia

Withdrawn

• Conditions: prostate hyperplasia; lower urinary tract symptoms; 10046590; 10036958

• Registration Number: NL-OMON40877
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Male patients, > 40 years
- Lower urinary tract symptoms (LUTS) secondary to Benign Prostate Hyperplasia (BPH)
- Symptoms refractory tomedical therapy(*-adrenergic antagonist and 5*-reductase inhibitor for at least 6 months), or contraindication to medical therapy.
- Patient must be eligible candidate for Transurethral Resection of the Prostate (TURP)
- IPSS (International Prostate Symptom Score) >18 and QoL >3, or both
- BOR (Bladder Outlet Resistance) Schäfer grade *2
- PV (Prostate Volume) > 30 cm³.
- PVR (Post-Void Residual ) * 100 ml.
- Qmax ( maximum flow rate) * 15 ml/sec.
- Patient has given written Informed consent

Exclusion Criteria

1. Active urinary tract infection or prostatitis
2. Suspicion of prostatic carcinoma during urologic work up for LUTS due to BPH.
3. Bladder atonia, acute urinary retention, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (eg multiple sclerosis, Parkinson's disease, spinal cord injuries, etc),
4. Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
5. Cystolithiasis or chronic hematuria within 3 months prior to study treatment
6. History of pelvic irradiation or radical pelvic surgery
7. Use of medication with negative effect on detrusor function.
8. Previous surgical procedures, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate or urethra.
9. Unable to undergo Magnetic Resonance Imaging
10. Allergy to iodinated contrast agents
11. Known upper tract renal disease or GFR * 59
12. Contraindications for angiography according to the UMC Utrecht standard of practice.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the urodynamic reduction of bladder outlet<br /><br>obstruction. Cystometry and urodynamic pressure flow are studied by assessing<br /><br>the following bladder outlet resistance parameters: Schäfer grade, BOOI<br /><br>(Bladder Outflow Obstruction Index = Abrams-Griffiths number), and urethral<br /><br>resistance factor (URA; >29 cm H2O =obstructed).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Post treatment IPSS, IPSS/QOL, PV, PSA are presented as means and standard<br /><br>deviations or medians (interquartile ranges) and are compared to baseline.<br /><br>Wilcoxon signed-rank tests or a paired t-test are used for statistical<br /><br>analysis.</p><br>