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

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ClinicalTrials.gov Identifier: NCT02178761
Recruitment Status : Unknown
Verified June 2014 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Lower Urinary Tract Symptoms Peripheral Arterial Disease Device: drug-eluting balloon Device: biodegradable vascular scaffold stent Device: Apex™ PTCA Dilatation Catheter Device: Stent System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Absorb Bioresorbable Vascular Scaffold System




Primary Outcome Measures :
  1. IIEF [ Time Frame: 1 year ]
    IIEF: Internal index for erectile function

  2. EPS [ Time Frame: 1 year ]
    EPS: erectile hardness score

  3. IPSS [ Time Frame: 1 year ]
    IPSS: international prostate symptom score


Secondary Outcome Measures :
  1. CT angiographic binary restenosis [ Time Frame: 1 year ]
    CT angiographic binary restenosis: ≥50% lumen diameter stenosis


Other Outcome Measures:
  1. Any major adverse events [ Time Frame: 1year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178761


Contacts
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Contact: Tzung-Dau Wang, MD, PhD +886-972651070 tdwang@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Contact: Tzung-Dau Wang, MD, PhD    +886-972651070    tdwang@ntu.edu.tw   
Principal Investigator: Tzung-Dau Wang, MD, PhD         
Principal Investigator: Wen-Jeng Lee, MD, PhD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Tzung-Dau Wang, MD, PhD NTUH

Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02178761    
Other Study ID Numbers: 201402003RINA
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014
Keywords provided by National Taiwan University Hospital:
Erectile dysfunction
Lower Urinary Tract Symptoms
Peripheral Arterial Disease
Angioplasty
Multidetector Computed Tomography
Additional relevant MeSH terms:
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Erectile Dysfunction
Peripheral Arterial Disease
Peripheral Vascular Diseases
Lower Urinary Tract Symptoms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Urological Manifestations
Signs and Symptoms
Chromium
Sirolimus
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances