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

Peripheral Arterial Disease Clinical Trial

— PERFECT  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02178761
• Other study ID #: 201402003RINA
• Status: Recruiting
• Phase: N/A
• First received: June 22, 2014
• Last updated: June 30, 2014
• Start date: October 2012
• Est. completion date: June 2016

Study information

• Verified date: June 2014
• Source: National Taiwan University Hospital
• Contact: Tzung-Dau Wang, MD, PhD
• Phone: +886-972651070
• Email: tdwang[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Lower Urinary Tract Symptoms
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• drug-eluting balloon
angioplasty completed with drug-eluting balloons
• biodegradable vascular scaffold stent
Stenting with biodegradable vascular scaffold stents
• Apex™ PTCA Dilatation Catheter
plain old balloon angioplasty alone
• Stent System
stenting with either bare-metal stents or drug-eluting stents

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Any major adverse events		1year	Yes
Primary	IIEF	IIEF: Internal index for erectile function	1 year	Yes
Primary	EPS	EPS: erectile hardness score	1 year	No
Primary	IPSS	IPSS: international prostate symptom score	1 year	No
Secondary	CT angiographic binary restenosis	CT angiographic binary restenosis: =50% lumen diameter stenosis	1 year	No