Shockwave Therapy for Erectile Dysfunction After Prostate Cancer Surgery

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Thomas Jefferson University

Must be taking: PDE5i

Disqualifiers: Penile surgery, Pacemakers, Metastatic disease, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase I clinical trial studies how well low intensity shockwave therapy (LiSWT) improves erectile function in patients who have had nerve-sparing radical prostatectomy (NS-RP), a type of surgery that attempts to save the nerves near the tissues being removed, for prostate cancer. Erectile dysfunction (ED) is a known side effect of the radical prostatectomy procedure. The low intensity shockwave therapy delivers painless electrotherapy pulse to increase blood flow and supply, activation of tissues and wound healing. Using LiSWT after NS-PRP may improve erectile function in men with prostate cancer.

Will I have to stop taking my current medications?

You will need to stop using all erectile aids, like prescription and non-prescription erectile medications not part of this study, penile injections, vacuum erection devices, and constriction rings, during the screening and study period. However, you must continue taking PDE5i medication throughout the study.

What data supports the effectiveness of the treatment for erectile dysfunction after prostate cancer surgery?

Research suggests that low-intensity extracorporeal shock wave therapy (Li-ESWT) can help improve erectile function by enhancing tissue repair and regeneration. While its effectiveness for erectile dysfunction after prostate surgery is still being studied, it has shown positive results in other types of erectile dysfunction. ^{1 2 3 4 5}

How is shockwave therapy different from other treatments for erectile dysfunction after prostate cancer surgery?

Shockwave therapy is unique because it uses low-intensity sound waves to potentially stimulate new blood vessel growth and nerve regeneration, which may help repair tissue and improve erectile function after prostate cancer surgery. Unlike medications or surgeries, this non-invasive treatment focuses on enhancing the body's natural healing processes. ^{1 2 3 6 7}

Research Team

Eligibility Criteria

Men aged 18-80 with localized prostate cancer who've had nerve-sparing surgery to remove the prostate and experience erectile dysfunction. They must be willing to take ED medication, attempt sexual activity, and have been in a sexual relationship for at least 3 months. Excluded are those with prior penile surgery, pacemakers, substance abuse issues, recent investigational drug use or certain treatments like PRP.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

Provide signed and dated informed consent form

I am willing to stop using any erectile aids not provided by this study.

Exclusion Criteria

I do not speak or understand English.

Patients with pacemakers or implantable defibrillators

Subject has received an investigational drug within 30 days prior to signing consent

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive LiSWT or sham treatment weekly for 6 weeks, followed by a 6-week break, and then another 6 weeks of weekly treatment

18 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including DDUS assessments

6 months

Regular follow-up visits

Treatment Details

Interventions

• LiSWT (Medical Device)

Trial Overview The trial is testing if low-intensity shockwave therapy can improve erectile function after prostate removal surgery. Men will receive this painless treatment that aims to increase blood flow and tissue healing. The study includes surveys and compares active treatment against sham (fake) interventions.

Participant Groups

Group I: ARM I (LiSWT) Experimental Treatment 4 Interventions

Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

Group II: ARM II (sham LiSWT) Placebo Group 4 Interventions

Patients undergo nerve-sparing radical prostatectomy per standard of care. Patients then receive sham LiSWT treatment weekly for 6 weeks, then have a 6 week break, followed by 6 more weekly treatments. Patients also undergo DDUS at baseline and during follow up.

LiSWT is already approved in Japan for the following indications:

Approved in Japan as LIESWT for:

• Erectile dysfunction post-prostatectomy

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Dr. Eugene Kennedy

Thomas Jefferson University

Chief Medical Officer since 2020

MD

Dr. Joseph G. Cacchione

Thomas Jefferson University

Chief Executive Officer since 2022

MD, MBA

Findings from Research

Low-intensity extracorporeal shockwave therapy (LI-ESWT) shows potential for improving erectile function in patients with erectile dysfunction (ED) after prostate surgery, especially when combined with phosphodiesterase type 5 inhibitors (PDE5Is).

However, the current evidence is limited due to small sample sizes, high risk of bias, and a lack of standardized treatment protocols, indicating a need for further randomized controlled trials to better understand its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity Extracorporeal Shockwave Therapy for the Management of Postprostatectomy Erectile Dysfunction: A Systematic Review of the Literature. Sighinolfi, MC., Eissa, A., Bellorofonte, C., et al.[2022]

Low-intensity extracorporeal shockwave therapy (LI-ESWT) showed a significant improvement in erectile function for patients who experienced erectile dysfunction after bilateral nerve-sparing radical prostatectomy, with median IIEF-5 score increases of +3.5 at one month and +1 at one year post-treatment.

The study involved 18 patients, with 16 completing the treatment analysis and no severe side effects reported, suggesting that LI-ESWT is a safe and feasible option for treating erectile dysfunction in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy in the treatment of postprostatectomy erectile dysfunction: a pilot study. Frey, A., Sønksen, J., Fode, M.[2016]

Low-intensity extracorporeal shock wave therapy (LI-ESWT) has been shown to effectively improve erectile function in patients with vasculogenic erectile dysfunction through multiple randomized-controlled trials.

The potential of LI-ESWT for treating erectile dysfunction resulting from radical prostatectomy remains uncertain, as most studies have excluded this condition, highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shock wave therapy for erectile dysfunction after radical prostatectomy: a review of preclinical studies. Zou, ZJ., Liang, JY., Liu, ZH., et al.[2018]

In a randomized clinical trial involving 60 patients, low-intensity extracorporeal shock wave therapy (Li-ESWT) significantly improved erectile function, as measured by various scales, at both 4 and 12 weeks post-treatment.

Patients reported increased satisfaction with their erections and overall sexual experience, with statistically significant improvements in scores for erection quality and partner satisfaction, indicating Li-ESWT is an effective treatment for erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial. Sramkova, T., Motil, I., Jarkovsky, J., et al.[2021]

Low-intensity extracorporeal shock wave therapy (Li-ESWT) demonstrated similar efficacy to sildenafil in treating erectile dysfunction, with no significant difference in International Index of Erectile Function-5 (IIEF-5) scores between the two treatments after three months.

Both Li-ESWT and sildenafil were found to have comparable safety profiles, with only mild and transient adverse events reported in both treatment groups, indicating that Li-ESWT could be a viable alternative to medication for erectile dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand sildenafil for erectile dysfunction. Lei, Q., Wang, D., Liu, C., et al.[2022]

Low-intensity extracorporeal shockwave therapy (Li-ESWT) shows potential for improving erectile function in men with erectile dysfunction (ED) following prostate cancer treatment, but the improvements observed in studies were not statistically significant.

There is a lack of standardized protocols and limited data on the effectiveness of Li-ESWT, particularly after radiation therapy, indicating a need for further research with longer follow-up periods to better understand its clinical significance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of low-intensity extracorporeal shockwave therapy in management of erectile dysfunction following prostate cancer treatment: a review of the current literature. Matthew, AN., Rogers, DE., Grob, G., et al.[2023]

Linear low-intensity extracorporeal shockwave therapy (LI-LiESWT) is a safe and effective method for rehabilitating erectile dysfunction (ED) in patients who have undergone bilateral nerve-sparing radical prostatectomy, showing sustained improvement in erectile function for up to 12 months after treatment.

The study involved 40 patients, with 32 completing the analysis, and demonstrated that LI-LiESWT not only improves blood flow (vasculogenic effect) but may also have neuroprotective and regenerative effects on erectile function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linear Low-Intensity Extracorporeal Shockwave Therapy as a Method for Penile Rehabilitation in Erectile Dysfunction Patients after Radical Prostatectomy: A Randomized, Single-Blinded, Sham-Controlled Clinical Trial. Motil, I., Macik, D., Sramkova, K., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Low-intensity Extracorporeal Shockwave Therapy for the Management of Postprostatectomy Erectile Dysfunction: A Systematic Review of the Literature. [2022]

2. Sweden pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shockwave therapy in the treatment of postprostatectomy erectile dysfunction: a pilot study. [2016]

3. England pubmed.ncbi.nlm.nih.gov

Low-intensity extracorporeal shock wave therapy for erectile dysfunction after radical prostatectomy: a review of preclinical studies. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Erectile Dysfunction Treatment Using Focused Linear Low-Intensity Extracorporeal Shockwaves: Single-Blind, Sham-Controlled, Randomized Clinical Trial. [2021]

5. China pubmed.ncbi.nlm.nih.gov

Comparison of the efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand sildenafil for erectile dysfunction. [2022]

6. China pubmed.ncbi.nlm.nih.gov

The use of low-intensity extracorporeal shockwave therapy in management of erectile dysfunction following prostate cancer treatment: a review of the current literature. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Linear Low-Intensity Extracorporeal Shockwave Therapy as a Method for Penile Rehabilitation in Erectile Dysfunction Patients after Radical Prostatectomy: A Randomized, Single-Blinded, Sham-Controlled Clinical Trial. [2022]