Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868668
Status:
RECRUITING
Last Update Posted:
2023-11-08
First Post:
2023-05-11
Brief Title:
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Randomized Controlled Trial of Focused Shockwave Radial Wave and Sham Therapy for Erectile Dysfunction and Pelvic Pain
Status:
RECRUITING
Status Verified Date:
2024-07
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 purpose of this study to perform a randomized sham controlled analysis of the effectiveness of both fSWT and rWT in the relief of erectile dysfunction and chronic pelvic pain syndrome
Detailed Description:
After being informed about the study and potential risks all patients giving written informed consent will undergo screening to determine eligibility for study entry Participants who meet eligibility requirements will be randomized in a double blind manner participant and investigator to each treatment arm depending on their primary complaint Participants with erectile dysfunction will be randomized 221 to either fSWT rWT or sham therapy Patients with chronic pelvic pain syndrome will be randomized 11 to either fSWT with pelvic floor physical therapy PFPT or PFPT with sham treatment
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