LiSWT for Men With Erectile Dysfunction

Low Intensity Shock Wave Therapy for Men With Mild to Moderate Erectile Dysfunction

The goal of this a clinical trial to investigate the effect of low-intensity shock wave therapy on patients with erectile function. The main questions it aims to answer are:

1. Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function?
2. What is the optimal LiSWT protocol (number of shocks, energy delivered, timeline, etc) for initial and maintenance therapy?

Researchers will compare validated questionnaires on erectile function in men treated with LiSWT compared to men who receive standard of care to see if there is an improvement in erectile function with LiSWT.

Participants will be asked to complete questionnaires at each visit. Those who choose to undergo LiSWT will receive 6 sessions, once per week.

Study Overview

• Status: Withdrawn
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Device: Low intensity shock wave; Combination product: Control

Detailed Description

Patients meeting inclusion criteria will be prospectively recruited from a single urological practice (Rutgers Urology, 125 Paterson St. Suite 4100, New Brunswick, NJ 08901) for this prospective study. They will be consented by a member of the research team within clinic. All consents and patient data will be stored in a HIPAA-compliant RedCap database. Patients who do not consent to LiSWT but want to participate in the study will be enrolled as a part of the Control group. These patients will also be recruited from a single urological practice as noted above, and consented by a member of the research team within clinic.

Patients who consent to the treatment arm will undergo LiSWT in clinic (typically up to 5,000 shocks per session, up to 6 weekly sessions), administered by study personnel with the MoreNova device (FDA-registered as a class 1 Therapeutic massager). Patients will be assessed for LiSWT complications and for erectile response with validated questionnaires at regular intervals: 1 month, 3 months, 6 months, and 1 year from LiSWT initiation. The patient's insurance will not be billed for the LiSWT sessions, but they will be billed for the follow-up visits. It is typical practice at Rutgers Urology to have any ED patients follow-up at these regular intervals when trialing alternative ED therapies, such as phosphodiesterase-5 inhibitors or intracavernosal injections. These will occur at regular clinic follow-up appointments, either via secure telehealth using the Epic electronic medical record platform or within the clinic. The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. The Erection Hardness Score (EHS) is another tool often used to evaluate and monitor the severity of ED.

Study patients will be compared to control patients with ED who elect for standard therapies and/or lifestyle modifications instead of LiSWT for ED. These control patients will be matched in a 1:1 ratio to the study patients and matched to study patients by age, SHIM and EHS scores, and co-morbidities.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Rutgers Robert Wood Johnson Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• Age >18
• Ability to make independent decisions (sign own consent)

Exclusion Criteria:

• Men reliant on penile injections for erections
• Men with current penile implant
• Prisoners
• Current anticoagulant / anti-platelet therapy
• Adults who cannot make their own medical decisions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LiSWT; men receiving LiSWT	Device: Low intensity shock wave; 6 sessions of low intensity shock wave therapy, applied in 15 minute appointments once weekly.; Other Names: MoreNova
Active Comparator: Control; Standard of care: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, penile implant.	Combination product: Control; Standard of care treatment: phosphodiesterase 5 inhibitor therapy, vacuum erectile device, constriction bands, intracorporal injections, and penile implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Health Inventory for Men (SHIM)	The Sexual Health Inventory for Men (SHIM) is a five-question, abbreviated, validated questionnaire derived from the International Index of Erectile Function questionnaire. It is widely used by urologists to evaluate efficacy of ED treatments. It is graded on a scale of 1-25, with higher scores indicating no signs of erectile dysfunction.	Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erection Hardness Score	The Erection Hardness Score (EHS) is another tool often used to evaluate and monitor the severity of ED. It is a four-point scale (1-4), with a score of 4 indicating a completely hard and fully rigid erection.	Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Danielle Velez Leitner, MD, Rutgers Health

Publications and helpful links

General Publications

• Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1.
• Zanaty F, Badawy A, Kotb H, Elsarfy F, Salman B. Efficacy and safety of low-intensity extracorporeal shock wave therapy versus on-demand tadalafil for erectile dysfunction. Arab J Urol. 2022 Jun 24;20(4):189-194. doi: 10.1080/2090598X.2022.2090134. eCollection 2022.
• Yao H, Wang X, Liu H, Sun F, Tang G, Bao X, Wu J, Zhou Z, Ma J. Systematic Review and Meta-Analysis of 16 Randomized Controlled Trials of Clinical Outcomes of Low-Intensity Extracorporeal Shock Wave Therapy in Treating Erectile Dysfunction. Am J Mens Health. 2022 Mar-Apr;16(2):15579883221087532. doi: 10.1177/15579883221087532.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Erectile Dysfunction
• Other Study ID Numbers: Pro2023002194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No