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Shockwave Therapy 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

Must not have

History of extensive pelvic surgery ever

Testosterone level <300 within 3 month prior to enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 3 and 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My latest HgbA1C level was 7.5% or lower.

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My testosterone level is above 300 ng/dL.

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I am a man aged between 31 and 79.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had major surgery in my pelvic area.

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My testosterone level was below 300 in the last 3 months.

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I have had a spinal cord injury in the past.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3 and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in IIEF/SHIM score (International Index of Erectile-Function-5, Sexual Health Inventory in Men) Score at 1 month post-treatment

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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.

0 / 6Eligibility criteria met