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

National Taiwan University

Status: Unknown

Conditions: Lower Urinary Tract Symptoms; Erectile Dysfunction; Peripheral Arterial Disease

Treatments: Device: Apex™ PTCA Dilatation Catheter; Device: Stent System; Device: drug-eluting balloon; Device: biodegradable vascular scaffold stent

Study type: Interventional

Funder types: Other

Identifiers

NCT02178761

201402003RINA

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

Angioplasty alone

Active Comparator group

Description:

plain old balloon angioplasty alone

Treatment:

Device: Apex™ PTCA Dilatation Catheter

Stenting

Active Comparator group

Description:

Balloon angioplasty plus stenting

Treatment:

Device: Stent System

drug-eluting balloon

Active Comparator group

Description:

Balloon angioplasty with drug-eluting balloon

Treatment:

Device: drug-eluting balloon

biodegradable vascular scaffold stent

Active Comparator group

Description:

Stenting with biodegradable vascular scaffold stent

Treatment:

Device: biodegradable vascular scaffold stent