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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City, Taiwan, 10002
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Tzung-Dau Wang, MD, PhD; Phone Number: +886-972651070; Email: tdwang@ntu.edu.tw
    • Principal Investigator: Wen-Jeng Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Angioplasty alone; plain old balloon angioplasty alone	Device: Apex™ PTCA Dilatation Catheter; plain old balloon angioplasty alone; Other Names: TREK & MINI TREK Coronary Dilatation Catheter; Sprinter Legend RX
ACTIVE_COMPARATOR: Stenting; Balloon angioplasty plus stenting	Device: Stent System; stenting with either bare-metal stents or drug-eluting stents; Other Names: Promus PREMIER™ Everolimus-Eluting Platinum Chromium Coronary Stent System; XIENCE PRIME Everolimus Eluting Coronary Stent System; Resolute Integrity Coronary Stent System; BioMatrix Flex™; Nobori® Drug Eluting Stent; MULTI-LINK 8 Coronary Stent System; Integrity Coronary Stent System
ACTIVE_COMPARATOR: drug-eluting balloon; Balloon angioplasty with drug-eluting balloon	Device: drug-eluting balloon; angioplasty completed with drug-eluting balloons; Other Names: SeQuent® Please
ACTIVE_COMPARATOR: biodegradable vascular scaffold stent; Stenting with biodegradable vascular scaffold stent	Device: biodegradable vascular scaffold stent; Stenting with biodegradable vascular scaffold stents; Other Names: Absorb Bioresorbable Vascular Scaffold System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IIEF	IIEF: Internal index for erectile function	1 year
EPS	EPS: erectile hardness score	1 year
IPSS	IPSS: international prostate symptom score	1 year

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Any major adverse events	1year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Tzung-Dau Wang, MD, PhD, NTUH

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2016
• Study Completion (ANTICIPATED): June 1, 2016

Study Registration Dates

• First Submitted: June 22, 2014
• First Submitted That Met QC Criteria: June 30, 2014
• First Posted (ESTIMATE): July 1, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 1, 2014
• Last Update Submitted That Met QC Criteria: June 30, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Multidetector Computed Tomography; Lower Urinary Tract Symptoms; Angioplasty; Erectile dysfunction; Peripheral Arterial Disease
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urological Manifestations; Atherosclerosis; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Peripheral Arterial Disease; Peripheral Vascular Diseases; Lower Urinary Tract Symptoms; Erectile Dysfunction; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Trace Elements; Micronutrients; Everolimus; Chromium
• Other Study ID Numbers: 201402003RINA