Vulvar Mucosal Specialty Clinic Chart Review
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02881229|
Recruitment Status : Terminated (Investigator is no longer at Northwestern University)
First Posted : August 26, 2016
Last Update Posted : October 9, 2020
|Condition or disease|
|Vulvar Disease Lichen Sclerosus Lichen Planus Vulvodynia|
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.
|Study Type :||Observational|
|Actual Enrollment :||719 participants|
|Official Title:||Open Ended Chart Review of Adult Women Presenting to the Vulvar Mucosal Specialty Clinic at Northwestern University Department of Dermatology|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||January 6, 2020|
|Actual Study Completion Date :||January 6, 2020|
Women in the Vulvar Specialty Clinic
Information will be collected from all patients presenting with vulvar complaints who have been seen by Dr. Schlosser in the Vulvar Mucosal Specialty Clinic at Northwestern Medical Group.
- Clinical database of patients presenting with vulvar complaints in order to comprehensively assess the presentation and current trends in the management of vulvar disease [ Time Frame: Through study completion, an average of 1 year ]
- Potential prognostic indicators in various vulvar conditions [ Time Frame: Through study completion, an average of 1 yea ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881229
|United States, Illinois|
|Northwestern University Feinberg School of Medicine|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Bethanee J Schlosser, MD, PhD||Northwestern University|