Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469775
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-17
Brief Title:
LiSWT for Men With Erectile Dysfunction
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Low Intensity Shock Wave Therapy for Men With Mild to Moderate Erectile Dysfunction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 5000 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 patients 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 andor lifestyle modifications instead of LiSWT for ED These control patients will be matched in a 11 ratio to the study patients and matched to study patients by age SHIM and EHS scores and co-morbidities
Patients who consent to the treatment arm will undergo LiSWT in clinic typically up to 5000 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 patients 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 andor lifestyle modifications instead of LiSWT for ED These control patients will be matched in a 11 ratio to the study patients and matched to study patients by age SHIM and EHS scores and co-morbidities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None