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Erectile Dysfunction-Penile Rehabilitation for Erectile Dysfunction

Phase < 1
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
Be older than 18 years old
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.

Eligible Conditions
  • Erectile Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3 and 6 months for reporting.

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.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,693 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
Recent research and studies
clinicaltrials.govStudy
Low Intensity Shockwave Therapy for Erectile Dysfunction
Ryan Smith, MD 2020. "Low Intensity Shockwave Therapy for Erectile Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04434352.
All > Erectile Dysfunction
~70 spots leftby Apr 2025
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