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Vulvar Contact Dermatitis Resulting From Urine Incontinence

This study is currently recruiting participants.
Verified April 2012 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01320046
First received: March 20, 2011
Last updated: January 30, 2013
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Urinary Incontinence
Vulvar Pruritus
Vulvar Contact Dermatitis
 Other: Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Vulvar Contact Dermatitis Resulting From Urine Incontinence: Prevalence, Characteristics and Risk Factors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Prevalence of vulvar contact dermatitis among patients with urinary incontinence [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Risk factors for urinary incontinence induced vulvar contact dermatitis [ Time Frame: one year ] [ Designated as safety issue: No ]
    Which risk factors contribute to the development of UI induced VCD: estrogen deficiency, allergic predisposition, other medical problems, UI severity etc.


Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 400
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 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 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

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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01320046

Contacts
Contact: Ahinoam Lev-Sagie, MD 972-2-5889500 ext 3 levsagie@netvision.net.il
Contact: Yuval Lavy, MD 972-2-5844111

Locations
Israel
Ramat Eshkol Women health center, Clalit health Services Recruiting
Jerusalem, Israel
Contact: Ahinoam Lev-Sagie, MD     972-2-5889500 ext 3     Levsagie@netvision.net.il    
Sponsors and Collaborators
Meir Medical Center
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01320046     History of Changes
Other Study ID Numbers: MMC11029-2011kCTIL
Study First Received: March 20, 2011
Last Updated: January 30, 2013
Health Authority: Israel: Clalit Health Services

Keywords provided by Meir Medical Center:
Urinary Incontinence
Vulvar pruritus
Vulvar contact dermatitis

Additional relevant MeSH terms:
Pruritus
Pruritus Vulvae
Dermatitis
Dermatitis, Contact
Urinary Incontinence
Skin Diseases
Skin Diseases, Eczematous
 Skin Manifestations
Signs and Symptoms
Vulvar Diseases
Genital Diseases, Female
Urination Disorders
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on May 19, 2013