NCT01835860

Brief Summary

To evaluate whether Prostatic Artery Embolization (PAE) might be an effective alternative treatment option for benign prostatic hyperplasia (BPH), in comparison to current gold standard surgical treatment- Transurethral Resection of Prostate (TURP).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

2.8 years

First QC Date

March 27, 2013

Last Update Submit

April 5, 2016

Conditions

Benign Prostate Hyperplasia

Keywords

BPH

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in symptom severity at 1, 3, 6 and 12 months follow-up, as measured by International prostate symptoms score (IPSS).

    1, 3, 6 and 12 months

Study Arms (1)

Embolization

OTHER

Prostate artery embolization

Procedure: Prostate artery embolization

Interventions

Prostate artery embolizationPROCEDURE
Embolization

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Moderate to severe lower urinary tract symptoms (i.e. International prostate symptom score IPSS\>8) who are bothered by their symptoms (i.e., interfere with the daily activities of living)
  • Urinary retention (related to BPH) leading to catheterization.
  • Refractory to medical treatment or patient is not willing to consider medical treatment
  • Pre trans-urethral resection of prostate (TURP) to reduce the size of prostate gland if prostate is too big for TURP surgery.

You may not qualify if:

  • Mild symptoms (IPSS \<8)
  • Moderate to severe lower urinary tract symptoms (i.e. IPSS\>8) who are not bothered by their symptoms (i.e., symptoms do not interfere with the daily activities of living).
  • Suspected malignancy.
  • Any of the following clearly related to BPH- bladder stones, recurrent UTIs, and renal insufficiency.
  • Advanced atherosclerosis and unsuitable vascular access.
  • Allergy to intravenous contra

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regina General Hospital

Regina, Saskatchewan, S4P 0W5, Canada

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2013

First Posted

April 19, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 7, 2016

Record last verified: 2016-04

Locations

CA(1)