Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00113555
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2005-06-08
Brief Title:
Adjustable Continence Therapy ACT Device for the Treatment of Female Stress Urinary Incontinence
Sponsor:
Uromedica
Organization:
Uromedica
Study Overview
Official Title:
Clinical Investigation of an Adjustable Continence Therapy ACT Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
Status:
COMPLETED
Status Verified Date:
2018-07
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:
ACT
Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons one on each side of the urethra are implanted to treat urinary stress incontinence
The results will be analyzed to demonstrate the effects of the device as well as its associated risks Therapeutic success will be based on whether the patients demonstrate at least a one-grade mean reduction in the Stamey score at 12 months
The results will be analyzed to demonstrate the effects of the device as well as its associated risks Therapeutic success will be based on whether the patients demonstrate at least a one-grade mean reduction in the Stamey score at 12 months
Detailed Description:
This is a multi-center prospective non randomized clinical trial comparing baseline data to the 12 month data Urodynamic testing pad weights and a direct visual stress test will be used to determine success along with the Stamey score
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None