Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125177
Status:
COMPLETED
Last Update Posted:
2010-11-10
First Post:
2005-07-27
Brief Title:
IRIS Incontinence Research Intervention Study
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Office for Research on Womens Health ORWH Specialized Centers of Research SCOR on Sex and Gender Factors Affecting Womens Health Project 3 Selection Criteria For Muscle Therapy in SUI
Status:
COMPLETED
Status Verified Date:
2005-07
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 IRIS project stands for Incontinence Research Intervention Study The purpose of this research project is to develop an effective behavioral therapy for urinary incontinence and specifically to test Knack therapy a self-help treatment The Knack therapy involves learning the skill of performing a pelvic muscle contraction simultaneously with an event known to trigger leakage in order to stop that leakage
Detailed Description:
This proposal aims to develop and test in a general population of women with stress urinary incontinence SUI a model for predicting who will succeed in overcoming incontinence long-term 1-year by simply using Knack therapy thus avoiding invasive and costly surgery and time consuming Kegels exercises Specific Aims are to
develop a logistic regression model to predict success with the Knack
validate the model by determining the proportion of people who succeed according to who is predicted to succeed and
develop long-term effectiveness of the Knack 1-year
The project will be implemented in three phases model development n160 women model validation n160 and long-term follow-up of women who demonstrate response This will be evaluated immediately and at 1 month and at 3-months and 1-year
develop a logistic regression model to predict success with the Knack
validate the model by determining the proportion of people who succeed according to who is predicted to succeed and
develop long-term effectiveness of the Knack 1-year
The project will be implemented in three phases model development n160 women model validation n160 and long-term follow-up of women who demonstrate response This will be evaluated immediately and at 1 month and at 3-months and 1-year
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1P50HD044406 | NIH | None | None |
| IRBMED 2002-0635 | OTHER | University of Michigan IRB | httpsreporternihgovquickSearch1P50HD044406 |