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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Angioplasty alone | Active Comparator | plain old balloon angioplasty alone |
|
| Stenting | Active Comparator | Balloon angioplasty plus stenting |
|
| drug-eluting balloon | Active Comparator | Balloon angioplasty with drug-eluting balloon |
|
| biodegradable vascular scaffold stent | Active Comparator | Stenting with biodegradable vascular scaffold stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-eluting balloon | Device | angioplasty completed with drug-eluting balloons |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| CT angiographic binary restenosis | CT angiographic binary restenosis: ≥50% lumen diameter stenosis | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Any major adverse events | 1year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tzung-Dau Wang, MD, PhD | Contact | +886-972651070 | tdwang@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Tzung-Dau Wang, MD, PhD | NTUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24832642 | Background | 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. |
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| biodegradable vascular scaffold stent | Device | Stenting with biodegradable vascular scaffold stents |
|
|
| Apex™ PTCA Dilatation Catheter | Device | plain old balloon angioplasty alone |
|
|
| Stent System | Device | stenting with either bare-metal stents or drug-eluting stents |
|
|
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D059411 | Lower Urinary Tract Symptoms |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
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