Vulvar Contact Dermatitis Resulting From Urine Incontinence
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ClinicalTrials.gov Identifier: NCT01320046 |
Recruitment Status :
Withdrawn
First Posted : March 22, 2011
Last Update Posted : April 8, 2015
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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.
Condition or disease | Intervention/treatment |
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Urinary Incontinence Vulvar Pruritus Vulvar Contact Dermatitis | Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Vulvar Contact Dermatitis Resulting From Urine Incontinence: Prevalence, Characteristics and Risk Factors |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |
Group/Cohort | Intervention/treatment |
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Patients with urinary incontinence
Patients attending the urogynecological clinic for urinary incontinence-100 patients. In this group we will recruit patients with UI, and will assess co-existence of VCD
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Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage
Patients will undergo the following evaluation:
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Patients with vulvar contact dermatitis
Patients attending the vulvovaginal clinic with vulvar contact dermatitis (100 patients). In this group we will recruit patients with VCD, and will assess co-existence of UI.
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Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage
Patients will undergo the following evaluation:
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Age matched control group
Patients attending the general clinic for annual checkup, which will be matched for age with the two other groups (200 patients). These patients will be evaluated for symptoms of UI and VCD |
- Prevalence of vulvar contact dermatitis among patients with urinary incontinence [ Time Frame: one year ]
- Risk factors for urinary incontinence induced vulvar contact dermatitis [ Time Frame: one year ]Which risk factors contribute to the development of UI induced VCD: estrogen deficiency, allergic predisposition, other medical problems, UI severity etc.
Biospecimen Retention: Samples Without DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
The prevalence of UI induced VCD will be evaluated in 3 groups:
- Patients attending the urogynecological clinic for urinary incontinence-100 patients. In this group we will recruit patients with UI, and will assess co-existence of VCD
- Patients attending the vulvovaginal clinic with vulvar contact dermatitis (100 patients). In this group we will recruit patients with VCD, and will assess co-existence of UI.
- Patients attending the general clinic for annual checkup, which will be matched for age with the two other groups (200 patients).
These patients will be evaluated for symptoms of UI and VCD
Inclusion Criteria:
- Patients with a diagnosis of vulvar contact dermatitis, with or without urinary incontinence; OR
- Patients with a diagnosis of urinary incontinence, with or without VCD; OR
- Patients without either UI or VCD, age-matched
Exclusion Criteria:
- Diagnosis of other dermatoses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01320046
Israel | |
Ramat Eshkol Women health center, Clalit health Services | |
Jerusalem, Israel |
Responsible Party: | Meir Medical Center |
ClinicalTrials.gov Identifier: | NCT01320046 |
Other Study ID Numbers: |
MMC11029-2011kCTIL |
First Posted: | March 22, 2011 Key Record Dates |
Last Update Posted: | April 8, 2015 |
Last Verified: | April 2012 |
Urinary Incontinence Vulvar pruritus Vulvar contact dermatitis |
Urinary Incontinence Enuresis Pruritus Vulvae Dermatitis Pruritus Dermatitis, Contact Skin Diseases Urination Disorders Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases |
Male Urogenital Diseases Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders Skin Manifestations Skin Diseases, Eczematous Vulvar Diseases Genital Diseases, Female Genital Diseases |