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Erectile Dysfunction-Penile Rehabilitation for Erectile Dysfunction
N/A
Waitlist Available
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment
Testosterone level > 300 ng/dL. This includes patients on therapeutic testosterone therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3 and 6 months
Awards & highlights
Study Summary
This trial looks at the safety and efficacy of low-intensity shockwave therapy for men with erectile dysfunction.
Who is the study for?
Men aged 30-80 with erectile dysfunction, especially those treated for prostate cancer over a year ago. They must have certain scores on sexual health questionnaires and testosterone levels above 300 ng/dL. Diabetics can join if their HgbA1C is under 7.5%. Men with neurological issues affecting erectile function, recent non-prostate cancer, or major pelvic surgery are excluded.Check my eligibility
What is being tested?
The trial tests Low Intensity Shockwave Therapy (LiSWT) to see if it's safe and effective for treating symptoms of erectile dysfunction in men. It's a controlled study comparing LiSWT against a sham treatment to measure improvements in sexual function.See study design
What are the potential side effects?
While the therapy is generally considered safe and well-tolerated, potential side effects specific to this treatment aren't detailed here but may include discomfort or pain at the site of application.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My latest HgbA1C level was 7.5% or lower.
Select...
My testosterone level is above 300 ng/dL.
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I am a man aged between 31 and 79.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3 and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment
Secondary outcome measures
Adverse Event Rates
Change in Erection Hardness Score at 1, 3, and 6 months
Changes in (International Index of Erectile-Function-5, Sexual Health Inventory in Men) at 3 and 6 months post-treatment
Trial Design
3Treatment groups
Active Control
Group I: Erectile Dysfunction-Penile RehabilitationActive Control1 Intervention
The second population of patients will be those who are planning to undergo treatment for prostate cancer. In a similar manner, men will be randomized to either the Sham or active treatment groups. Men will be treated prior to undergoing definitive treatment for prostate cancer to assess the effectiveness in LiSWT as a means of erectile preservation prior to prostate cancer treatment.
Group II: Erectile Dysfunction Post-Prostate Cancer TreatmentActive Control1 Intervention
The third population of patients will be those who have undergone treatment for prostate cancer. The investigators will compare IIEF scores and EHS scores in men who have undergone prostatectomy or radiation therapy. Again, there will be a sham and treatment group.
Group III: Baseline Erectile DysfunctionActive Control1 Intervention
The first arm of the study will be those men with erectile dysfunction as defined by IIEF score. These men will either have PDE5i refractory or responsive erectile dysfunction. Subjects will receive either Sham treatment (no ultrasound energy delivered via a Sham probe) or LiSWT for erectile dysfunction. Follow up will occur at 1 month, 3 months, and 6 months following the end of treatment. Effectiveness will be measured by change in IIEF/SHIM score and EHS score. Each questionnaire is described in the trial description with a higher score indicating improved function.
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Who is running the clinical trial?
University of VirginiaLead Sponsor
757 Previous Clinical Trials
1,244,910 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Will this clinical trial be beneficial for patients who are middle-aged?
"The aim of this clinical trial is to enrol patients that are between 30 and 80 years old."
Answered by AI
Who would be an ideal candidate for participation in this research project?
"This clinical trial is looking for 338 patients with erectile dysfunction aged 30 and 80. Most notable, patients must meet the following criteria: The patient must be willing and able to provide informed consent., The patient is a male between >30 and <80 years of age., PDE5i responsive or non-responsive. If on PDE5i patient will discontinue medication for 2 weeks before baseline IIEF., Baseline IIEF-EF score ≥ 8 and ≤21. If taking PDE5i, stop medication for at least 4 weeks before baseline IIEF., Men who have undergone radical prostatectomy ≥ 12 months"
Answered by AI
Are there any slots left for new volunteers in this clinical trial?
"This trial, which was originally posted on June 1st 2020, is not currently recruiting patients. However, there are 64 other trials that are actively recruiting patients right now."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
University of Virginia
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
This trial gives me hope that it may help me to get better.
PatientReceived no prior treatments
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