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临床试验/NCT01320046
NCT01320046撤回不适用

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

Meir Medical Center1 个研究点 分布在 1 个国家开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Prevalence of vulvar contact dermatitis among patients with urinary incontinence

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • Diagnosis of other dermatoses

结局指标

主要结局

Prevalence of vulvar contact dermatitis among patients with urinary incontinence

时间窗: one year

次要结局

  • Risk factors for urinary incontinence induced vulvar contact dermatitis(one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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