Clinical trial NCT01320046: Vulvar Contact Dermatitis Resulting From Urine Incontinence
Official title: Vulvar Contact Dermatitis Resulting From Urine Incontinence: Prevalence, Characteristics and Risk Factors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urinary Incontinence
Vulvar Pruritus
Vulvar Contact Dermatitis
Keywords: Urinary Incontinence
Vulvar pruritus
Vulvar contact dermatitis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The prevalence of UI induced VCD will be evaluated in 3 groups:

1. 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
2. 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.
3. 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of vulvar contact dermatitis among patients with urinary incontinence
timeFrame: one year
Secondary outcomes:
measure: Risk factors for urinary incontinence induced vulvar contact dermatitis
timeFrame: one year
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Ramat Eshkol Women health center, Clalit health Services
Study officials:
References:
citation: Margesson LJ. Contact dermatitis of the vulva. Dermatol Ther. 2004;17(1):20-7. doi: 10.1111/j.1396-0296.2004.04003.x.
citation: Farage MA, Miller KW, Berardesca E, Maibach HI. Incontinence in the aged: contact dermatitis and other cutaneous consequences. Contact Dermatitis. 2007 Oct;57(4):211-7. doi: 10.1111/j.1600-0536.2007.01199.x.
citation: Crone AM, Stewart EJ, Wojnarowska F, Powell SM. Aetiological factors in vulvar dermatitis. J Eur Acad Dermatol Venereol. 2000 May;14(3):181-6. doi: 10.1046/j.1468-3083.2000.00080.x.