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Medical Device

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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient reported sexual function
Secondary outcome measures
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

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,657 Total Patients Enrolled

Media Library

LiSWT (Medical Device) Clinical Trial Eligibility Overview. Trial Name: NCT05877144 — N/A
Erectile Dysfunction Research Study Groups: ARM I (LiSWT), ARM II (sham LiSWT)
Erectile Dysfunction Clinical Trial 2023: LiSWT Highlights & Side Effects. Trial Name: NCT05877144 — N/A
LiSWT (Medical Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05877144 — N/A
~8 spots leftby Oct 2024
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