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Shock Wave Therapy

Low-Intensity Shock Wave Therapy for Erectile Dysfunction

N/A
Waitlist Available
Led By Danielle Velez Leitner, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18
Male sex presenting with mild to severe erectile dysfunction for at least six months, as defined by SHIM score 1-21 and/or an EHS 0-3
Must not have
Men reliant on penile injections for erections
Men with current penile implant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
Awards & highlights

Summary

"This trial aims to study the impact of low-intensity shock wave therapy on men with erectile dysfunction. They want to see if this therapy can improve male sexual health, specifically erectile function. The researchers will

Who is the study for?
This trial is for men with erectile dysfunction. Participants will be asked to complete questionnaires and those opting for LiSWT will undergo six weekly sessions. Details on inclusion and exclusion criteria are not provided.
What is being tested?
The study tests if low-intensity shock wave therapy (LiSWT) can improve erectile function in men compared to standard care, seeking the best treatment protocol through validated questionnaires.
What are the potential side effects?
Potential side effects of LiSWT are not detailed in the provided information but may include discomfort or pain during or after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18.
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I have had erectile dysfunction for at least 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use injections for erections.
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I have a penile implant.
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I am currently on blood thinners.
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I am unable to make my own medical decisions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sexual Health Inventory for Men (SHIM)
Secondary study objectives
Erection Hardness Score

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LiSWTExperimental Treatment1 Intervention
men receiving LiSWT
Group II: ControlActive Control1 Intervention
Standard of care: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, penile implant.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,282 Total Patients Enrolled
Danielle Velez Leitner, MDPrincipal InvestigatorRutgers Health
~67 spots leftby Sep 2029
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