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

Not Applicable

• Conditions: Erectile Dysfunction; Peripheral Arterial Disease; Lower Urinary Tract Symptoms
• Interventions: Device: Stent System; Device: Apex™ PTCA Dilatation Catheter; Device: drug-eluting balloon; Device: biodegradable vascular scaffold stent

• Registration Number: NCT02178761
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Status Verified: 2014-06
• Study First Submitted: 2014-06-22
• Study First Submitted QC: 2014-06-30
• Last Update Submitted: 2014-06-30
• Study First Posted: 2014-07-01
• Last Update Posted: 2014-07-01
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stenting	Stent System	Balloon angioplasty plus stenting
Angioplasty alone	Apex™ PTCA Dilatation Catheter	plain old balloon angioplasty alone
drug-eluting balloon	drug-eluting balloon	Balloon angioplasty with drug-eluting balloon
biodegradable vascular scaffold stent	biodegradable vascular scaffold stent	Stenting with biodegradable vascular scaffold stent

Primary Outcome Measures

Name	Time	Method
IPSS	1 year	IPSS: international prostate symptom score
IIEF	1 year	IIEF: Internal index for erectile function
EPS	1 year	EPS: erectile hardness score

Secondary Outcome Measures

Name	Time	Method
CT angiographic binary restenosis	1 year	CT angiographic binary restenosis: ≥50% lumen diameter stenosis

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei City, Taiwan