Vulvar Contact Dermatitis Resulting From Urine Incontinence

• ClinicalTrials.gov Identifier: NCT01320046
• Recruitment Status: Withdrawn
• First Posted: March 22, 2011
• Last Update Posted: April 8, 2015
• Sponsor: Meir Medical Center
• Information provided by (Responsible Party): Meir Medical Center

Tracking Information

• First Submitted Date: March 20, 2011
• First Posted Date: March 22, 2011
• Last Update Posted Date: April 8, 2015
• Study Start Date: March 2011
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 21, 2011): Prevalence of vulvar contact dermatitis among patients with urinary incontinence [ Time Frame: one year ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 21, 2011)

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

Which risk factors contribute to the development of UI induced VCD: estrogen deficiency, allergic predisposition, other medical problems, UI severity etc.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Vulvar Contact Dermatitis Resulting From Urine Incontinence
• 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 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples Without DNA

Description:

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

• 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

Condition

• Urinary Incontinence
• Vulvar Pruritus
• Vulvar Contact Dermatitis

Intervention

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

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.

Study Groups/Cohorts

• 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
  Intervention: 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.
  Intervention: 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

Publications *

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

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 7, 2015): 0
• Original Estimated Enrollment (submitted: March 21, 2011): 400
• Actual Study Completion Date: March 2012
• Actual Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT01320046
• Other Study ID Numbers: MMC11029-2011kCTIL
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Meir Medical Center
• Original Responsible Party: Ahinoam Lev-Sagie, MD, Clalit Health Services, Israel
• Current Study Sponsor: Meir Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Meir Medical Center
• Verification Date: April 2012