Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223106
Status:
COMPLETED
Last Update Posted:
2015-07-27
First Post:
2005-09-12
Brief Title:
Treatment for Stress and Mixed Urinary Incontinence and Vaginal Vault Prolapse
Sponsor:
Medtronic - MITG
Organization:
Medtronic - MITG
Study Overview
Official Title:
A Prospective Multicenter Clinical Study on a New Approach in Treating Stress and Mixed Incontinence and Vaginal Vault Prolapse
Status:
COMPLETED
Status Verified Date:
2015-07
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 primary objective of this study is to further evaluate the safety and effectiveness of the use of a sling device in women for stress and mixed urinary incontinence as well as vaginal vault prolapse
Detailed Description:
Urinary incontinence is the involuntary loss of urine and can affect both men and women throughout their lives Women are more likely to develop incontinence as a result of pregnancy and childbirth There are approximately 11 million cases of incontinence in the US contributing to several different types of incontinence including
Urge - 30 of the market
Stress - 30 of the market of which 85 are women
Combination urge and stress - 40
Despite advances in behavioral therapy pharmacological advances as well as development of minimally invasive surgical procedures only one out of every twelve people affected actually seek help
Prolapse
Globally approximately 1 million women suffer uterovaginal prolapse annually and this condition can be associated with urinary incontinence The breakdown of treatments for uterovaginal prolapse includes
20 - no treatment
20 - non surgical management pessary
60 - receive a surgical procedure of a suture repair or mesh repair
There were greater than 600000 surgeries performed globally to treat prolapse These numbers are projected to increase due to rapid easy and less costly methods as well as new products that facilitate the easier procedures
Urge - 30 of the market
Stress - 30 of the market of which 85 are women
Combination urge and stress - 40
Despite advances in behavioral therapy pharmacological advances as well as development of minimally invasive surgical procedures only one out of every twelve people affected actually seek help
Prolapse
Globally approximately 1 million women suffer uterovaginal prolapse annually and this condition can be associated with urinary incontinence The breakdown of treatments for uterovaginal prolapse includes
20 - no treatment
20 - non surgical management pessary
60 - receive a surgical procedure of a suture repair or mesh repair
There were greater than 600000 surgeries performed globally to treat prolapse These numbers are projected to increase due to rapid easy and less costly methods as well as new products that facilitate the easier procedures
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