Clinical trial NCT02178761: Imaging and Interventional Study for Erectile Dysfunction and Lower Urinary Tract Symptoms
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erectile Dysfunction
Lower Urinary Tract Symptoms
Peripheral Arterial Disease
Keywords: Erectile dysfunction
Lower Urinary Tract Symptoms
Peripheral Arterial Disease
Angioplasty
Multidetector Computed Tomography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-07-01
Enrollment: 300
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: IIEF
timeFrame: 1 year
measure: EPS
timeFrame: 1 year
measure: IPSS
timeFrame: 1 year
Secondary outcomes:
measure: CT angiographic binary restenosis
timeFrame: 1 year
Other outcomes:
measure: Any major adverse events
timeFrame: 1year
Locations:
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: NTUH
name: Tzung-Dau Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.