Vulvar Mucosal Specialty Clinic Chart Review

Vulvodynia Clinical Trial

Official title:

Open Ended Chart Review of Adult Women Presenting to the Vulvar Mucosal Specialty Clinic at Northwestern University Department of Dermatology

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02881229
• Other study ID #: STU00001056
• Status: Terminated
• Start date: April 2016
• Est. completion date: January 6, 2020

Study information

• Verified date: October 2020
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 719
• Est. completion date: January 6, 2020
• Est. primary completion date: January 6, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Sclerosus
• Lichen Sclerosus et Atrophicus
• Vulvar Disease
• Vulvar Diseases
• Vulvodynia

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in the management of vulvar disease		Through study completion, an average of 1 year
Secondary	Potential prognostic indicators in various vulvar conditions		Through study completion, an average of 1 yea