Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05773378
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-01-14
Brief Title:
Do Intravaginal Devices Reduce Urinary Incontinence in Female Runners
Sponsor:
University of Ottawa
Organization:
University of Ottawa
Study Overview
Official Title:
Do Intravaginal Devices Reduce or Eliminate Exercise Induced Urinary Incontinence in Female Runners
Status:
RECRUITING
Status Verified Date:
2023-11
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:
More than one in five females experience the embarrassment and shame of urine leakage while exercising and this urinary incontinence UI is a substantial barrier to exercise As many as one in three females with UI report that they limit their physical activity due to incontinence 116 by not exercising at all 113 by exercising less and 124 by changing the type of exercise they perform It is imperative to look for alternatives to manage this condition as it is a key reason why females abandon the very physical exercise that is necessary to maintain or improve their physical and mental health and their quality of life
While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations no study has evaluated the impact of conservative interventions specifically on UI experienced predominantly during running
While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations no study has evaluated the impact of conservative interventions specifically on UI experienced predominantly during running
Detailed Description:
Urinary incontinence UI is a serious public health concern imposing a significant financial burden In Canada the direct and indirect health costs associated with UI total over 36 billion annually and no estimates of disease burden take into account deconditioning that results from withdrawal from physical activity nor effects on mental health or quality of life Although the primary risk factor for UI is pregnancy and vaginal delivery it was recently reported that between 20 and 40 of nulliparous females report urine leakage when they engage in physical activity
Urinary continence is maintained as long as urethral closure pressure remains higher than bladder pressure This is accomplished through a complex combination of mechanisms including smooth and striated urethral sphincter muscle action urethral venous engorgement and mucous secretions within the urethra and the proper transfer of loads to the urethra which depends on adequate bladder neck and urethral connective tissue support as well as pelvic floor muscle PFM action The associations among physical activity pelvic floor morphology and function and UI are not clear A recent systematic review retrieved 18 mainly small studies investigating the association between physical activity and pelvic floor dysfunction Exercise at mild to moderate intensity appears to be protective decreasing both the odds and the risk of experiencing urinary incontinence However females who engage in high-impact activities such as running are more likely to report UI during exercise than those who engage in mild or moderate intensity exercise thus chronic and repetitive loading of the pelvic floor may have negative consequences
While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations no study has investigated about interventions specific to running-induced UI
Urinary continence is maintained as long as urethral closure pressure remains higher than bladder pressure This is accomplished through a complex combination of mechanisms including smooth and striated urethral sphincter muscle action urethral venous engorgement and mucous secretions within the urethra and the proper transfer of loads to the urethra which depends on adequate bladder neck and urethral connective tissue support as well as pelvic floor muscle PFM action The associations among physical activity pelvic floor morphology and function and UI are not clear A recent systematic review retrieved 18 mainly small studies investigating the association between physical activity and pelvic floor dysfunction Exercise at mild to moderate intensity appears to be protective decreasing both the odds and the risk of experiencing urinary incontinence However females who engage in high-impact activities such as running are more likely to report UI during exercise than those who engage in mild or moderate intensity exercise thus chronic and repetitive loading of the pelvic floor may have negative consequences
While there is Grade A evidence for pelvic floor muscle training and some evidence for intravaginal pessaries to reduce symptoms of UI in general female populations no study has investigated about interventions specific to running-induced UI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None