Prostatic Artery Embolization for Benign Prostatic Hyperp... | NCT01835860

Studies
Prostatic Artery Embolization for Benign Prostatic Hyperplasia

NCT01835860

Sponsor

Saskatchewan Health Authority - Regina Area

Status

Completed

Last Update Posted

Apr 7, 2016Estimated

Enrollment

13Actual

Phase

Phase 2Phase 3

Conditions

Benign Prostate Hyperplasia

Interventions

Prostate artery embolization

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Mar 27, 2013

First Submission Date that Met QC Criteria

Apr 16, 2013

First Posted Date

Apr 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2016

Last Update Posted Date

Apr 7, 2016Estimated

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Embolization	Other	Prostate artery embolization	Procedure: Prostate artery embolization

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prostate artery embolization	Procedure		Embolization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Regina General Hospital		Regina	Saskatchewan	S4P 0W5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D011469	Prostatic Diseases
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided