Low Intensity Shockwave Therapy for Erectile Dysfunction

Who is this study for? Patients with Erectile Dysfunction
What treatments are being studied? Storz Duolith Low-Intensity Shockwave Therapy
Status: Active_not_recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: Male
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

• Testosterone level \> 300 ng/dL. This includes patients on therapeutic testosterone therapy.

• If diabetic, HgbA1C level ≤ 7.5% within 3 months prior to enrollment.

• Men who have undergone radical prostatectomy ≥ 12 months ago

• Men who have undergone radiation therapy, either brachytherapy or external bean therapy ≥ 12 months ago

Locations
United States
Virginia
University of Virginia
Charlottesville
Time Frame
Start Date: 2020-06-01
Completion Date: 2025-01-09
Participants
Target number of participants: 338
Treatments
Active_comparator: Baseline Erectile Dysfunction
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.
Active_comparator: Erectile Dysfunction-Penile Rehabilitation
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.
Active_comparator: Erectile Dysfunction Post-Prostate Cancer Treatment
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.
Sponsors
Leads: University of Virginia

This content was sourced from clinicaltrials.gov