Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03308409
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2017-10-09
Brief Title:
Comparative Effectiveness and Safety of Three Protocols Usin Li-ESWT for Erectile Dysfunction
Sponsor:
Boston Medical Group
Organization:
Boston Medical Group
Study Overview
Official Title:
Clinical Randomized Multicentric Trial to Evaluate the Comparative Effectiveness and Safety of Three Protocols Using Low-intensity Shock Waves for the Treatment of Erectile Dysfunction
Status:
COMPLETED
Status Verified Date:
2023-10
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 patients with primary erectile dysfunction IIEF-EF 26 points will be randomly assigned to three shockwave treatment protocols Protocol 1 six sessions one per week Protocol 2 six initial sessions one per week followed by monthly maintenance sessions every 4 weeks for five months Protocol 3 six monthly sessions The EHS and IIEF-EF scores will be compared as well as the possible adverse events from the therapy upon beginning and completing the treatment and at the 3-month and 6-month follow-ups Self-esteem and quality of life will also be evaluated using the SEAR scale
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None