PERFECT: Imaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02178761

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Lower Urinary Tract Symptoms Peripheral Arterial Disease	Device: drug-eluting balloon Device: biodegradable vascular scaffold stent Device: Apex™ PTCA Dilatation Catheter Device: Stent System	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comprehensive Imaging and Interventional Therapy Studies for Arteriogenic Erectile Dysfunction and Lower Urinary Tract Symptoms: A Multi-modality, Multi-Specialty Collaborative Study (PERFECT Program)

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Angioplasty alone plain old balloon angioplasty alone	Device: Apex™ PTCA Dilatation Catheter plain old balloon angioplasty alone Other Names: TREK & MINI TREK Coronary Dilatation Catheter Sprinter Legend RX
Active Comparator: Stenting Balloon angioplasty plus stenting	Device: Stent System stenting with either bare-metal stents or drug-eluting stents Other Names: Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System XIENCE PRIME Everolimus Eluting Coronary Stent System Resolute Integrity Coronary Stent System BioMatrix Flex™ Nobori® Drug Eluting Stent MULTI-LINK 8 Coronary Stent System Integrity Coronary Stent System
Active Comparator: drug-eluting balloon Balloon angioplasty with drug-eluting balloon	Device: drug-eluting balloon angioplasty completed with drug-eluting balloons Other Names: SeQuent® Please
Active Comparator: biodegradable vascular scaffold stent Stenting with biodegradable vascular scaffold stent	Device: biodegradable vascular scaffold stent Stenting with biodegradable vascular scaffold stents Other Names: Absorb Bioresorbable Vascular Scaffold System

Outcome Measures

Primary Outcome Measures

IIEF [1 year]
IIEF: Internal index for erectile function
EPS [1 year]
EPS: erectile hardness score
IPSS [1 year]
IPSS: international prostate symptom score

Secondary Outcome Measures

CT angiographic binary restenosis [1 year]
CT angiographic binary restenosis: ≥50% lumen diameter stenosis

Other Outcome Measures

Any major adverse events [1year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

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
the anatomical inclusion criteria, based on pelvic CT angiography, are unilateral luminal diameter stenosis >=70% or bilateral diameter stenoses >=50% in the pelvic arteries with reference vessel diameter >=2.5 mm and <=4.0 mm and a target-lesion length <=40 mm

Exclusion Criteria:

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