Clinical trial NCT06469775: LiSWT for Men With Erectile Dysfunction
Official title: Low Intensity Shock Wave Therapy for Men With Mild to Moderate Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Erectile Dysfunction
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2024-06-24
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

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
* 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

Primary outcomes:
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
Secondary outcomes:
measure: Erection Hardness Score
timeFrame: Performed at baseline, and then at each follow-up appointment (3, 6, 12, 24 months)
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
Study officials:
affiliation: Rutgers Health
name: Danielle Velez Leitner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.