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: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for erectile dysfunction (ED) using low-intensity shockwave therapy (LiSWT). The aim is to determine if LiSWT can improve erectile function by addressing underlying issues rather than merely treating symptoms. The trial includes three groups: men with baseline ED, men planning prostate cancer treatment, and men who have already received prostate cancer treatment. Men experiencing ED, whether related to prostate cancer treatment or unresponsive to typical medications, might be suitable candidates. As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatment options for ED.

Will I have to stop taking my current medications?

If you are taking PDE5 inhibitors (a type of medication for erectile dysfunction), you will need to stop them for at least 4 weeks before the baseline assessment. The protocol does not specify about other medications, so it's best to discuss with the trial team.

What prior data suggests that low-intensity shockwave therapy is safe for treating erectile dysfunction?

Research has shown that low-intensity shockwave therapy (LiSWT) is safe and generally well-tolerated, with most patients experiencing no significant side effects. For instance, one study found that 60% of patients who did not respond to other treatments found LiSWT effective and safe over a year.

Another study demonstrated improvements in erectile function after one month compared to a placebo, with no major safety concerns. LiSWT has also been used safely in other medical areas, such as treating certain muscle and heart issues, supporting its safety for erectile dysfunction.

Overall, while LiSWT is widely accepted and considered safe, further research is needed to confirm its effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Shockwave Therapy for Erectile Dysfunction stands out because it uses low-intensity shockwaves to potentially improve blood flow and promote tissue regeneration in the penis. While most treatments for erectile dysfunction, like PDE5 inhibitors (e.g., Viagra, Cialis), mainly focus on temporarily increasing blood flow, shockwave therapy aims to address the underlying physical issues more permanently. Researchers are excited about this approach because it has the potential to improve erectile function without the need for ongoing medication, offering a more sustainable solution. Additionally, its non-invasive nature makes it an attractive option for those seeking alternatives to oral medications or surgical interventions.

What evidence suggests that this trial's treatments could be effective for erectile dysfunction?

Research shows that low-intensity shockwave therapy (LiSWT), which participants in this trial may receive, can help men with erectile dysfunction. Studies found that men who received LiSWT scored better on tests of erectile function than those who received a placebo treatment. This improvement can last for at least six months after therapy. However, the long-term effects remain uncertain, as the benefits might not extend beyond two years. The treatment is considered safe, but more research is needed to fully understand its effectiveness. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-intensity shockwave therapy (LiSWT) or sham treatment for erectile dysfunction

6 weeks

Weekly visits for treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Follow-up visits at 1, 3, and 6 months post-treatment

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. storzmedical.com storzmedical.com/en/disciplines/literature-database-blog/database-cpps-ipp-ed/lange-m-et-al-2024/

Lange M. et al., 2024: Is low-intensity shockwave therapy ... Although LiSWT has been shown to improve erectile function amongst men with ED, few studies have examined its long-term durability.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04434352

Low Intensity Shockwave Therapy for Erectile Dysfunction 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 ...

3. tau.amegroups.org tau.amegroups.org/article/view/130285/html

Is low-intensity shockwave therapy for erectile dysfunction a ... Improvements in erectile function seem to decline after 2 years, suggesting that treatment benefits are not indefinite.

4. academic.oup.com academic.oup.com/jsm/article/20/Supplement_1/qdad060.336/7165054

(360) Low-Intensity Shockwave Therapy (LiSWT) Appears to ... (360) Low-Intensity Shockwave Therapy (LiSWT) Appears to Show Improvement in Erectile Function at 1 Month Compared to SHAM in Men with Erectile ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10642534/

Low-intensity shockwave therapy improves baseline ... Low-intensity shockwave therapy improves erectile function in men with erectile dysfunction as compared with sham treatment, which persists even 6 months after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5121537/

Twelve-Month Efficacy and Safety of Low-Intensity ... LISWT in patients with ED unresponsive to PDE5i treatment was effective and safe in 60% of patients treated. The efficacy response was maintained for 12 months ...