Shockwave Therapy for Erectile Dysfunction

Overseen By Ryan P Smith, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Virginia

Disqualifiers: Extensive pelvic surgery, Neurological disease, Anatomical malformation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

338 Participants Needed

Trial Summary

What is the purpose of this trial?

Low-intensity shockwave therapy (LiSWT) has been deemed "a safe and well-tolerated procedure but its efficacy for the treatment of ED is doubtful and deserves more investigation" by the European Society of Sexual Medicine. In a similar manner, the Sexual Medicine Society of North America and American Urological Association have put forth guideline statements recommending additional investigation of this treatment modality.2 The current clinical armamentarium only treats the symptoms of erectile dysfunction without improving upon the underlying pathophysiology. LiSWT has been used effectively in musculoskeletal disorders and cardiovascular applications. Animal studies have shown improvements in angiogenesis and stem cell recruitment in other systems (cardiac and musculoskeletal) using shockwave therapy. It has been used to treat erectile dysfunction since 2010 and is widely used in Europe and throughout the world. It is gaining widespread acceptance in the United States with a relative paucity of data in regards to its effectiveness. While the majority of studies and meta-analyses show improvements in standardized erectile dysfunction questionnaires (IIEF/SHIM-Sexual Health Inventory in Men, International Index of Erectile Function-5) the durability remains unknown and many have lacked a sham-arm. In addition, many studies have failed to assess a population of men who have highly prevalent erectile dysfunction, those men undergoing prostate cancer treatment. This is a prospective, randomized, single blind, sham-controlled clinical study aimed to evaluate the safety and efficacy of low-intensity shockwave therapy (LiSWT) on symptomatic ED patients in three distinct patient populations. LiSWT has shown the potential to improve baseline erectile function but requires further study, which is the aim of this investigation.

Eligibility Criteria

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.

Inclusion Criteria

I am a man aged between 31 and 79.

I have or have not responded to ED medication and will stop taking it for 2 weeks before the test.

My erectile function score is between 8 and 21, and I've stopped any ED medication for 4 weeks.

Exclusion Criteria

I have had major surgery in my pelvic area.

I have had radiation therapy in the pelvic area within the last year.

I have recovered from a non-prostate cancer within the last year.

Treatment Details

Interventions

• Storz Duolith Low-Intensity Shockwave Therapy

Trial Overview 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.

Participant Groups

Group I: Erectile Dysfunction-Penile Rehabilitation Active Control 1 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 Treatment Active Control 1 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 Dysfunction Active Control 1 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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+