Imaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms
PERFECT
Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms: A Multi-modality, Multi-Specialty Collaborative Study (PERFECT Program)
1 other identifier
interventional
300
1 country
1
Brief Summary
Erectile dysfunction is highly prevalent as men grow older. Among the various causes of erectile dysfunction, it has been shown that pelvic arterial insufficiency plays a very important role. The investigators have recently developed the first imaging analytical algorithm by using the abdominal/pelvis multidetector computed tomographic (MDCT) angiography to delineate the whole arterial system supplying the penis. To establish a comprehensive, cutting-edge diagnostic and interventional therapeutic program for erectile dysfunction, the investigators therefore design this series of studies by including experts from Urology, Radiology, and Cardiology. This research project (PERFECT program) includes the following 4 sub-studies: 1) differential frequency of obstructive pelvic arterial lesions in coronary artery disease patients with and without erectile dysfunction/lower urinary tract symptoms (LUTS), 2) differential frequency of obstructive pelvic arterial lesions in patients with vascular risk factors and with or without erectile dysfunction/LUTS, 3) safety, feasibility, and efficacy of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: proof-of-concept study; and 4) efficacy and safety of comprehensive pelvic angioplasty (with various interventional strategies/instruments) for patients with erectile dysfunction/LUTS and pelvic obstructive arterial disease: a randomized controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
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
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 1, 2014
June 1, 2014
3.7 years
June 22, 2014
June 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
IIEF
IIEF: Internal index for erectile function
1 year
EPS
EPS: erectile hardness score
1 year
IPSS
IPSS: international prostate symptom score
1 year
Secondary Outcomes (1)
CT angiographic binary restenosis
1 year
Other Outcomes (1)
Any major adverse events
1year
Study Arms (4)
Angioplasty alone
ACTIVE COMPARATORplain old balloon angioplasty alone
Stenting
ACTIVE COMPARATORBalloon angioplasty plus stenting
drug-eluting balloon
ACTIVE COMPARATORBalloon angioplasty with drug-eluting balloon
biodegradable vascular scaffold stent
ACTIVE COMPARATORStenting with biodegradable vascular scaffold stent
Interventions
angioplasty completed with drug-eluting balloons
Stenting with biodegradable vascular scaffold stents
plain old balloon angioplasty alone
stenting with either bare-metal stents or drug-eluting stents
Eligibility Criteria
You may qualify if:
- men 20 years of age or older with "consistent" erectile dysfunction defined as both IIEF-5 scores, taken at least 4 weeks apart, are in the range of 5 to 21 points and with a difference of \<=2 points
You may not qualify if:
- the arterial inflow to the penis is entirely from the accessory pudendal arteries rather than the usual internal pudendal artery and common penile artery;
- the presence of focal diameter stenosis \>=70% in the common iliac artery, internal iliac artery, or anterior division of internal iliac artery;
- previous radical prostatectomy, pelvic radiation, or Peyronie's disease;
- untreated hypogonadism (serum total testosterone \<300 ng/dL within 14 days before enrollment);
- acute coronary syndrome, stroke, or life-threatening arrhythmia within 3 months before enrollment;
- poorly controlled diabetes mellitus with glycosylated hemoglobin levels \>9%;
- serum creatinine levels \>2.5 mg/dL;
- bleeding diathesis or known hypercoagulopathy;
- life expectancy of fewer than 12 months;
- known intolerance to contrast agents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 10002, Taiwan
Related Publications (1)
Wang TD, Lee WJ, Yang SC, Lin PC, Tai HC, Hsieh JT, Liu SP, Huang CH, Chen WJ, Chen MF. Safety and six-month durability of angioplasty for isolated penile artery stenoses in patients with erectile dysfunction: a first-in-man study. EuroIntervention. 2014 May;10(1):147-56. doi: 10.4244/EIJV10I1A23.
PMID: 24832642BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tzung-Dau Wang, MD, PhD
NTUH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2014
First Posted
July 1, 2014
Study Start
October 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 1, 2014
Record last verified: 2014-06