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

NCT ID: NCT02178761

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Erectile Dysfunction; Lower Urinary Tract Symptoms; Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Angioplasty alone

plain old balloon angioplasty alone

Group Type: ACTIVE_COMPARATOR

Apex™ PTCA Dilatation Catheter

Intervention Type: DEVICE

plain old balloon angioplasty alone

Stenting

Balloon angioplasty plus stenting

Group Type: ACTIVE_COMPARATOR

Stent System

Intervention Type: DEVICE

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

drug-eluting balloon

Balloon angioplasty with drug-eluting balloon

Group Type: ACTIVE_COMPARATOR

drug-eluting balloon

Intervention Type: DEVICE

angioplasty completed with drug-eluting balloons

biodegradable vascular scaffold stent

Stenting with biodegradable vascular scaffold stent

Group Type: ACTIVE_COMPARATOR

biodegradable vascular scaffold stent

Intervention Type: DEVICE

Stenting with biodegradable vascular scaffold stents

Interventions

drug-eluting balloon

angioplasty completed with drug-eluting balloons

Intervention Type: DEVICE

biodegradable vascular scaffold stent

Stenting with biodegradable vascular scaffold stents

Intervention Type: DEVICE

Apex™ PTCA Dilatation Catheter

plain old balloon angioplasty alone

Intervention Type: DEVICE

Stent System

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

Intervention Type: DEVICE

Other Intervention Names

SeQuent® Please; Absorb Bioresorbable Vascular Scaffold System; TREK & MINI TREK Coronary Dilatation Catheter; Sprinter Legend RX; 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

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

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tzung-Dau Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tzung-Dau Wang, MD, PhD

Role: CONTACT

tdwang@ntu.edu.tw

+886-972651070

Facility Contacts

Tzung-Dau Wang, MD, PhD

Role: primary

tdwang@ntu.edu.tw

+886-972651070

References

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.

Reference Type: BACKGROUND

PMID: 24832642 (View on PubMed)

Other Identifiers

201402003RINA

Identifier Type: -

Identifier Source: org_study_id