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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02178761

Acronym

PERFECT

Enrollment

300

Registered

2014-07-01

Start date

2012-10-31

Completion date

2016-06-30

Last updated

2014-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease

Keywords

Erectile dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease, Angioplasty, Multidetector Computed Tomography

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.

Interventions

DEVICEdrug-eluting balloon

angioplasty completed with drug-eluting balloons

DEVICEbiodegradable vascular scaffold stent

Stenting with biodegradable vascular scaffold stents

DEVICEApex™ PTCA Dilatation Catheter

plain old balloon angioplasty alone

DEVICEStent System

stenting with either bare-metal stents or drug-eluting stents

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
CT angiographic binary restenosis	1 year	CT angiographic binary restenosis: ≥50% lumen diameter stenosis

Other

Measure	Time frame
Any major adverse events	1year

Countries

Taiwan

Contacts

Primary ContactTzung-Dau Wang, MD, PhD

tdwang@ntu.edu.tw+886-972651070

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026