Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04758247
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2021-02-10
Brief Title:
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
Sponsor:
Theranova LLC
Organization:
Theranova LLC
Study Overview
Official Title:
Evaluation of the TheraNova Neuromodulation System for the Treatment of Overactive Bladder Symptoms
Status:
COMPLETED
Status Verified Date:
2024-02
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:
To evaluate the safety and effectiveness of the TheraNova Neuromodulation System in overactive bladder OAB patients The primary safety endpoint will be device-related adverse events The primary effectiveness endpoint will be urinary urge incontinence UUI responder rate at 12 weeks a responder is defined as a subject who experiences at least a 50 reduction in the mean frequency of UUI events per day from baseline to 12 weeks as measured in the 3-day voiding diaries Responder rate will be compared between subjects randomized to the active treatment vs the sham treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None