Ignite Creation Date:
2024-05-05 @ 11:25 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01320046
Status:
WITHDRAWN
Last Update Posted:
2015-04-08
First Post:
2011-03-20
Brief Title:
Vulvar Contact Dermatitis Resulting From Urine Incontinence
Sponsor:
Meir Medical Center
Organization:
Meir Medical Center
Study Overview
Official Title:
Vulvar Contact Dermatitis Resulting From Urine Incontinence Prevalence Characteristics and Risk Factors
Status:
WITHDRAWN
Status Verified Date:
2012-04
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:
Vulvar contact dermatitis VCD is a common problem presenting as vulvar pruritus burning or irritation Its estimated prevalence is 20-30 in vulvar clinics but the prevalence in the general population is unknown
Contact dermatitis is an inflammation of the skin resulting from an external agent that acts as an irritant or as an allergen The skin reaction may be acute subacute or chronic resulting from prolonged exposure to weak irritating substances
The most common form of VCD is irritant contact dermatitis and it usually presents as vulvar itch The causes that contribute to VCD are increased sensitivity of the vulvar skin to irritants compared to other body parts decrease in the skin barrier function due to exposure to sweat urine and vaginal discharge and constant friction of the vulvar area In menopausal women lack of estrogen contributes to tissue atrophy and thinning and may increase the effect of irritants on the vulvar skin
One of the most common irritating substances that cause VCD is urine The phenomenon of urine-induced VCD is known as diaper rash in babies and it was also described in bedridden patients using diapers constantly Women with urine incontinence UI a problem that its prevalence in women increases with aging may use constantly panty liners or pads to prevent urine leakage The urine is being absorbed in the pad and the vulvar skin is continually exposed to urine This can cause VCD similar to diaper rash The prevalence of this phenomenon in the general population is unknown
The patients complain of itch burning or irritation of the vulvar skin and on exam erythema edema and irritated skin are found As most patients do not connect between UI to their vulvar disorder and as most care-givers do not ask routinely about UI the vulvar symptoms are mistakenly attributed to yeast infection or other factors As the cause to the vulvar complaints is not recognized patients do not receive proper treatment that requires primary management of UI
The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize risk factors for UI induced VCD
Contact dermatitis is an inflammation of the skin resulting from an external agent that acts as an irritant or as an allergen The skin reaction may be acute subacute or chronic resulting from prolonged exposure to weak irritating substances
The most common form of VCD is irritant contact dermatitis and it usually presents as vulvar itch The causes that contribute to VCD are increased sensitivity of the vulvar skin to irritants compared to other body parts decrease in the skin barrier function due to exposure to sweat urine and vaginal discharge and constant friction of the vulvar area In menopausal women lack of estrogen contributes to tissue atrophy and thinning and may increase the effect of irritants on the vulvar skin
One of the most common irritating substances that cause VCD is urine The phenomenon of urine-induced VCD is known as diaper rash in babies and it was also described in bedridden patients using diapers constantly Women with urine incontinence UI a problem that its prevalence in women increases with aging may use constantly panty liners or pads to prevent urine leakage The urine is being absorbed in the pad and the vulvar skin is continually exposed to urine This can cause VCD similar to diaper rash The prevalence of this phenomenon in the general population is unknown
The patients complain of itch burning or irritation of the vulvar skin and on exam erythema edema and irritated skin are found As most patients do not connect between UI to their vulvar disorder and as most care-givers do not ask routinely about UI the vulvar symptoms are mistakenly attributed to yeast infection or other factors As the cause to the vulvar complaints is not recognized patients do not receive proper treatment that requires primary management of UI
The aim of the study is to evaluate the prevalence of VCD in women with UI and to recognize risk factors for UI induced VCD
Detailed Description:
None
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