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

Study Overview
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Brief Summary
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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.

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

Conditions
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Erectile Dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease

Intervention / Treatment
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* Device: drug-eluting balloon
* Device: biodegradable vascular scaffold stent
* Device: Apex™ PTCA Dilatation Catheter
* Device: Stent System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Angioplasty alone<br>plain old balloon angioplasty alone | Device: Apex™ PTCA Dilatation Catheter<br>* plain old balloon angioplasty alone<br>* Other names: Sprinter Legend RX;|
| Active Comparator: Stenting<br>Balloon angioplasty plus stenting | Device: Stent System<br>* stenting with either bare-metal stents or drug-eluting stents<br>* Other names: Integrity Coronary Stent System;|
| Active Comparator: drug-eluting balloon<br>Balloon angioplasty with drug-eluting balloon | Device: drug-eluting balloon<br>* angioplasty completed with drug-eluting balloons<br>* Other names: SeQuent® Please;|
| Active Comparator: biodegradable vascular scaffold stent<br>Stenting with biodegradable vascular scaffold stent | Device: biodegradable vascular scaffold stent<br>* Stenting with biodegradable vascular scaffold stents<br>* Other names: Absorb Bioresorbable Vascular Scaffold System;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Angioplasty, Erectile dysfunction, Lower Urinary Tract Symptoms, Peripheral Arterial Disease, Multidetector Computed Tomography