Prostatic Artery Embolization for Benign Prostatic Obstruction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperplasia Prostatic
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Ability to void spontaneously
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The aim of this study is to investigate the safety and efficacy of prostatic artery embolization (PAE) for patients who refuse or are not eligible for surgery with moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostate obstruction due to benign prostatic hyperplasia.
Detailed Description
This is a prospective study investigating the safety and efficacy of PAE for patients who refuse or are not eligible for surgery and who suffers from moderate-severe lower urinary tract symptoms or indwelling catheter secondary to benign prostatic obstruction due to benign prostatic hyperplasia. It may form the grounding for further research in the shape of a larger randomised clinical trial. Our hypothesis is that PAE will eliminate the need for indwelling catheter and improve IPSS 6 months post-procedure. 1, and 6 months follow-up. Main outcome Ability to void after removal of indwelling catheter Secondary outcomes International Prostate Symptom Score (IPSS) Quality of Life (QoL) International Index of Erectile Function (IIEF) Prostate volume Peak void flow (Qmax) Post-void residual (PVR) Classify complications according to Society of Interventional Radiology (SIR) guidelines for reporting Prostate-specific antigen (PSA)
Investigators
Brian Malling
MD
Rigshospitalet, Denmark
Eligibility Criteria
Inclusion Criteria
- •Indwelling catheter secondary to benign prostatic hyperplasia (BPH) or
- •Moderate-severe Obstructive LUTS secondary to BPH refractory to medical treatment
- •Unsuitable for TURP or refuse surgery
Exclusion Criteria
- •Bladder dysfunction(and known neurological conditions affecting bladder function)
- •Urethral strictures
- •Bladder neck contracture
- •Known sphincter anomalies
- •Big bladder diverticulum or stones
- •Kidney insufficiency (eGFR \< 45)
- •Coagulation disturbances
- •Severe atheromatous or tortuosity of arteries
- •Allergy to contrast medium
- •Unable to undergo MR imaging
Outcomes
Primary Outcomes
Ability to void spontaneously
Time Frame: 6 months
Patient demonstrate the ability to void spontanously after the removal of the indwelling catheter at 6 months
Secondary Outcomes
- PVR(1, 6 months)
- QoL(1, 6 months)
- PSA(1, 6 months)
- IIEF(1, 6 months)
- PV(1, 6 months)
- Qmax(1, 6 months)
- IPSS(1, 6 months)