Vulvar Contact Dermatitis Resulting From Urine Incontinence

NCT01320046 | Withdrawn

• 1 other identifier: MMC11029-2011kCTIL
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence; Vulvar Pruritus; Vulvar Contact Dermatitis

Keywords

Urinary Incontinence; Vulvar pruritus; Vulvar contact dermatitis

Outcome Measures

Primary Outcomes (1)

• Prevalence of vulvar contact dermatitis among patients with urinary incontinence

  one year

Secondary Outcomes (1)

• Risk factors for urinary incontinence induced vulvar contact dermatitis

  one year

Study Arms (3)

Patients with urinary incontinence

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

Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage

Patients with vulvar contact dermatitis

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.

Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage

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

Interventions

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.

Patients with urinary incontinence; Patients with vulvar contact dermatitis

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of other dermatoses

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Ramat Eshkol Women health center, Clalit health Services

Jerusalem, Israel

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal smears taken for evaluation of vaginal estrogen status (identifying parabasal cells, vaginal flora, vaginal pH)

MeSH Terms

Conditions

Urinary Incontinence; Pruritus Vulvae

Interventions

Surveys and Questionnaires; Vaginal Smears

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vulvar Diseases; Genital Diseases, Female; Genital Diseases; Pruritus; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Obstetrical and Gynecological; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2011
• First Posted: March 22, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 8, 2015

Record last verified: 2012-04

Locations

IL (1)