Clinical Trial: Vulvar Contact Dermatitis Resulting From Urine Incontinence

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Vulvar Contact Dermatitis Resulting From Urine Incontinence: Prevalence, Characteristics and Risk Factors

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 diso

Detailed Summary:
Sponsor: Meir Medical Center

Current Primary Outcome: Prevalence of vulvar contact dermatitis among patients with urinary incontinence [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Risk factors for urinary incontinence induced vulvar contact dermatitis [ Time Frame: one year ]

Original Secondary Outcome: Same as current

Information By: Meir Medical Center

Dates:
Date Received: March 20, 2011
Date Started: March 2011
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2012