Vulvar Contact Dermatitis Resulting From Urine Incontinence

Withdrawn

• Conditions: Urinary Incontinence; Vulvar Pruritus; Vulvar Contact Dermatitis
• Interventions: Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage

• Registration Number: NCT01320046
• Lead Sponsor: Meir Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-20
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-22
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with urinary incontinence	Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage	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 with vulvar contact dermatitis	Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage	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.

Primary Outcome Measures

Name	Time	Method
Prevalence of vulvar contact dermatitis among patients with urinary incontinence	one year

Secondary Outcome Measures

Name	Time	Method
Risk factors for urinary incontinence induced vulvar contact dermatitis	one year	Which risk factors contribute to the development of UI induced VCD: estrogen deficiency, allergic predisposition, other medical problems, UI severity etc.

Trial Locations

Locations (1)

Ramat Eshkol Women health center, Clalit health Services; 🇮🇱 Jerusalem, Israel