Ignite Creation Date:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2026-01-05 @ 7:23 PM
Study NCT ID:
NCT03335761
Status:
COMPLETED
Last Update Posted:
2021-01-08
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
InterStim® Amplitude Study
Sponsor:
MedtronicNeuro
Organization:
Study Overview
Official Title:
InterStim® Amplitude Study
Status:
COMPLETED
Status Verified Date:
2020-12
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:
This feasibility study will explore the effects of three different InterStim amplitude settings on overactive bladder symptoms (OAB).
Detailed Description:
This is a prospective, randomized, multicenter, single-blinded study to explore the efficacy and quality of life (QoL) of 3 different amplitude settings.
Study Oversight
Has Oversight DMC:
False
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?:
True
Is an FDA AA801 Violation?: