Clinical trial NCT03099421: Prostatic Artery Embolization for Benign Prostatic Obstruction
Official title: Prostatic Artery Embolization for Benign Prostatic Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperplasia Prostatic
Lower Urinary Tract Symptoms
Prostatic Diseases
Urological Manifestations
Keywords: Benign prostatic obstruction
benign prostatic enlargement
benign prostatic hyperplasia
prostatic artery embolization
Quality of Life
IPSS
DAN-PSS
Complications
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 11
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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
* Urological malignancy

Primary outcomes:
measure: Ability to void spontaneously
timeFrame: 6 months
Secondary outcomes:
measure: IPSS
timeFrame: 1, 6 months
measure: QoL
timeFrame: 1, 6 months
measure: IIEF
timeFrame: 1, 6 months
measure: PV
timeFrame: 1, 6 months
measure: PVR
timeFrame: 1, 6 months
measure: Qmax
timeFrame: 1, 6 months
measure: PSA
timeFrame: 1, 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Radiologisk Klinik, Rigshospitalet
name: Lars Lönn, Professor
role: STUDY_CHAIR
References: