Clinical trial NCT02881229: Vulvar Mucosal Specialty Clinic Chart Review
Official title: Open Ended Chart Review of Adult Women Presenting to the Vulvar Mucosal Specialty Clinic at Northwestern University Department of Dermatology
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Vulvar Disease
Lichen Sclerosus
Lichen Planus
Vulvodynia
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 719
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Women seen at the Vulvar Mucosal Specialty Clinic

Brief summary: This study aims to develop a clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in management of vulvar disease.

Detailed description: Vulvar disorders are common, but their frequency and importance are often under-recognized. The spectrum of vulvar disease is vast and includes congenital malformations, inflammatory mucocutaneous diseases, blistering and erosive diseases, benign and malignant tumors, autoimmune disorders, infectious diseases, and various idiopathic conditions. Evaluation and management of genital complaints and dermatoses are complicated by the frequent multifactorial nature of vulvar symptoms and variable clinical expressions of disease on the vulva. In many cases, empiric treatment is instituted in the absence of a definitive diagnosis. Of note, expertise in the diagnosis and management of vulvar disorders is often lacking on the parts of gynecology, dermatology and primary care physicians.

The investigators seek to analyze the data on this patient population at Northwestern Memorial Hospital (NMH) and the outpatient clinics of the Northwestern Memorial Faculty Foundation (NMFF) to better define the clinical spectrum of vulvar disease. The investigators will also assess approaches to the diagnosis and management of patients with vulvar disease with attention given to clinical outcome and the impact on quality of life. This information with help the investigators to better understand the scope of care these patients currently receive, to identify deficits in current practice, and to advance potential new standards of care.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Patients seen at Northwestern Medical Group Department of Dermatology who were seen by Dr. Bethanee Schlosser and/or other members of the Vulvar Mucosal Specialty Clinic team in any of their respective clinic settings.

Exclusion Criteria:

* Patients who refuse complete mucocutaneous examination.
* Patients who refuse recommended diagnostic procedures.
* Pregnant women or prisoners.

Primary outcomes:
measure: Clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in the management of vulvar disease
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Potential prognostic indicators in various vulvar conditions
timeFrame: Through study completion, an average of 1 yea
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: Bethanee J Schlosser, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: