Shockwave Therapy for Erectile Dysfunction After Prostate Cancer Surgery

Overseen By Paul Chung, MD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Must be taking: PDE5i

Disqualifiers: Penile surgery, Pacemakers, Metastatic disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if low-intensity shockwave therapy (LiSWT) can improve erectile function in men who have undergone nerve-sparing radical prostatectomy for prostate cancer. LiSWT uses painless electrotherapy pulses that may enhance blood flow and promote tissue healing. Participants will receive either the actual LiSWT or a sham (fake) treatment for comparison. Men who have had prostate surgery, are taking certain erectile medications, and are willing to engage in sexual activity during the study may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore a potentially beneficial treatment for improving post-surgery erectile function.

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 prior data suggests that this shockwave therapy is safe for improving erectile function after prostate cancer surgery?

Research has shown that low-intensity shockwave therapy (LiSWT) is safe for people. Studies have found that starting LiSWT after prostate surgery does not cause significant harm, with participants experiencing no major negative side effects. Another study found that LiSWT promotes cell growth without harming cells or their DNA, indicating that the treatment does not damage the body at a cellular level. Overall, LiSWT appears to be well-tolerated with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about LiSWT (Low-intensity Shockwave Therapy) for erectile dysfunction after prostate cancer surgery because it offers a non-invasive treatment option that may enhance blood flow and promote tissue regeneration in the penis. Unlike the standard of care options, such as oral medications like Viagra or penile injections, LiSWT uses acoustic waves to stimulate the body's natural healing processes without the need for drugs or needles. This innovative approach could potentially lead to improved erectile function with fewer side effects, making it a promising alternative for patients who have undergone prostate surgery.

What evidence suggests that LiSWT is effective for improving erectile function after prostate cancer surgery?

Research has shown that low-intensity shockwave therapy (LiSWT), which participants in this trial may receive, might help men improve their ability to have erections after prostate surgery. Studies have found that LiSWT can slightly boost scores related to erectile function, indicating that some men experienced better erections after the treatment. Another study highlighted that LiSWT is safe and could work well, especially if started soon after surgery. While results can differ, this treatment seems promising for men facing erection problems after prostate surgery. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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

Score 12 or higher on the pre-operative International Index of Erectile Function (IIEF) assessment

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• LiSWT

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.

How Is the Trial Designed?

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 United States, European Union, Japan for the following indications:

Approved in United States as Low-Intensity Extracorporeal Shock Wave Therapy for:

• Erectile dysfunction (ED) post-prostatectomy

Approved in European Union as Li-ESWT for:

• Vasculogenic erectile dysfunction
• Erectile dysfunction post-prostatectomy

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+

Published Research Related to This Trial

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]

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) 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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06717711

Low-Intensity Extracorporeal Shockwave Therapy on ... In this scenario, LiESWT has been recently introduced, showing promising results 9,10. It differs from other ED treatments, due to its action on the underlying ...

2. auajournals.org auajournals.org/doi/pdf/10.1097/JU.0000000000004576

A Prospective Randomized Study on Low-Energy ... This study suggests that LI-SWT, as applied in this study, is unlikely to be an effective treatment mo- dality for postprostatectomy ED. ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2050116121000180

Erectile Dysfunction A Prospective Randomized Placebo ... This randomized study showed a slight increase in mean IIEF-5 and EHS in men with ED following RARP treated with Li-ESWT. The mean IIEF-5 and EHS scores ...

4. cureus.com cureus.com/articles/420840-low-intensity-extracorporeal-shock-wave-therapy-li-eswt-for-erectile-dysfunction-in-patients-post-prostatectomy-a-systematic-review.pdf?email=

Low-Intensity Extracorporeal Shock Wave Therapy (LI- ... LI-ESWT appears to be a safe and potentially effective treatment for ED following radical prostatectomy, particularly when initiated early and ...

5. mdpi.com mdpi.com/2077-0383/11/10/2775

Efficacy of Low-Intensity Extracorporeal Shock Wave ... The results of this analysis indicate that LI-ESWT showed a statistically significant effect on early recovery in penile rehabilitation of ED following RP.

6. academic.oup.com academic.oup.com/jsm/advance-article/doi/10.1093/jsxmed/qdaf305/8307682

Early low-intensity extracorporeal shockwave therapy for the ... Our findings show that starting Li-ESWT early after RARP is safe. We did not observe any significant differences in biochemical recurrence ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11449405/

Safety of low-intensity extracorporeal shock wave therapy ... Based on our findings, Li-ESWT promotes cellular growth and motility without inducing significant cell membrane or DNA damage or alterations.