Vulvar Contact Dermatitis Resulting From Urine Incontinence

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01320046
• Other study ID #: MMC11029-2011kCTIL
• Status: Withdrawn
• Phase: N/A
• First received: March 20, 2011
• Last updated: April 7, 2015
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Eczema
• Pruritus
• Urinary Incontinence
• Vulvar Contact Dermatitis
• Vulvar Pruritus

Intervention

Other:
• Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage
Patients will undergo the following evaluation: Questionnaires- age, medical background, BMI, UI characteristics , usage of pads, other hygiene practices,hormonal therapy, presence of allergic tendency and history etc. Medical history. Gynecological exam including bladder/rectum/uterine prolapse, vaginal atrophy, discharge, findings of VCD (as part of the usual evaluation in the clinic). 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. Evaluation of the severity of urinary incontinence will be done by collection and weighting of pads during 24 hours.

Locations

Country	Name	City	State
Israel	Ramat Eshkol Women health center, Clalit health Services	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Crone AM, Stewart EJ, Wojnarowska F, Powell SM. Aetiological factors in vulvar dermatitis. J Eur Acad Dermatol Venereol. 2000 May;14(3):181-6. — View 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. Review. — View Citation

Margesson LJ. Contact dermatitis of the vulva. Dermatol Ther. 2004;17(1):20-7. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of vulvar contact dermatitis among patients with urinary incontinence		one year	No
Secondary	Risk factors for urinary incontinence induced vulvar contact dermatitis	Which risk factors contribute to the development of UI induced VCD: estrogen deficiency, allergic predisposition, other medical problems, UI severity etc.	one year	No