Vulvar Contact Dermatitis Resulting From Urine Incontinence

NCT01320046 — Withdrawn, Meir Medical Center

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01320046
Status	Withdrawn
Study type	Observational
Sponsor	Meir Medical Center (Other)
Conditions	Urinary Incontinence, Vulvar Pruritus, Vulvar Contact Dermatitis
Interventions	Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage (Other)
Dates	start 2011-03-01, primary completion 2012-03-01, completion 2012-03-01, first posted 2011-03-22, last updated 2015-04-08
Locations	1 site in Israel

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Interventions	Description
Patients with urinary incontinence	Other: 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	Other: 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.
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

Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage (Other): Patients will undergo the following evaluation: 1. Questionnaires- age, medical background, BMI, UI characteristics , usage of pads, other hygiene practices,hormonal therapy, presence of allergic tendency and history etc. 2. Medical history. 3. Gynecological exam including bladder/rectum/uterine prolapse, vaginal atrophy, discharge, findings of VCD (as part of the usual evaluation in the clinic). 4. Vaginal smear: this will be used for vaginal pH measurement and for wet mount, which will assess estrogen deficiency, yeast infection and other inflammatory conditions. Vaginal smears are done as part of the usual evaluation in the clinic. 5. Evaluation of the severity of urinary incontinence will be done by collection and weighting of pads during 24 hours.

+Outcome measures

Primary outcomes

Prevalence of vulvar contact dermatitis among patients with urinary incontinence [one year]

Secondary outcomes

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.

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Ramat Eshkol Women health center, Clalit health Services	Jerusalem	Israel

+Publications

Margesson LJ. Contact dermatitis of the vulva. Dermatol Ther. 2004;17(1):20-7. doi: 10.1111/j.1396-0296.2004.04003.x. PMID 14756887
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. PMID 17868212
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. PMID 11032061