Low Intensity Shock Wave Therapy for Men With Mild to Moderate Erectile Dysfunction
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Rutgers, The State University of New Jersey
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Sexual Health Inventory for Men (SHIM)
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief Summary
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:
- Can low-intensity shock wave therapy (LiSWT) to the penis improve male sexual health, particularly erectile function?
- 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.
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.
Investigators
Danielle Velez Leitner
Assistant Professor
Rutgers, The State University of New Jersey
Eligibility Criteria
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
- •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
Outcomes
Primary Outcomes
Sexual Health Inventory for Men (SHIM)
Time Frame: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
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.
Secondary Outcomes
- Erection Hardness Score(Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months))