Shockwave Therapy for Erectile Dysfunction After Prostate Cancer Surgery

N/A

Recruiting

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months post liswt initiation

Summary

This trial tests LiSWT to see if it can improve erectile dysfunction after nerve-sparing prostatectomy for prostate cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects of LiSWT may include mild pain during treatment, skin redness or bruising where treated, temporary swelling of the penis or surrounding area.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months post liswt initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months post liswt initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months post liswt initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient reported sexual function

Secondary study objectives

Change in duplex doppler ultrasound measurement

Erectile function

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ARM I (LiSWT)Experimental Treatment4 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 Group4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Duplex Ultrasound

2019

N/A

~90

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