Dyspareunia Clinical Trial
Official title:
Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
Previous research has shown that semen deposition in the vagina after intercourse leads to dripping, discomfort, and vaginal odor. This study is evaluating a hygiene device designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 15, 2021 |
Est. primary completion date | September 15, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 25 Years to 50 Years |
Eligibility | Inclusion Criteria: - Heterosexual - Age 25-50 - Has used tampons in the past 5 years - Sexually active (vaginal intercourse, minimum once per week) - Answered "moderate" to "severe" to being bothered by dripping/discomfort on Patient Global Impression of Severity (PGI-S) questionnaire "on minutes, hours, or following day" - Willing and able to use product - Understands, reads, writes, and speaks English Exclusion Criteria: - Pregnant - Currently using condoms - Unable to use device due to poor motor function - Chronic disease which makes prone to infection (diabetes, autoimmune) - Recurrent yeast infections - Recurrent Urinary tract infection (UTI) (>2 within the past year) - Diagnosis of pelvic organ prolapse (Stage II or greater) - Previous pelvic or vaginal surgery which, in the opinion of the investigator, may prevent proper use of product - Unable to sign informed consent |
Country | Name | City | State |
---|---|---|---|
United States | The Center for Specialized Women's Health, division of Garden State Urology | Denville | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Atlantic Health System |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Global Impression of Improvement (PGI-I) | Validated Questionnaire | within 1 hour of use of product | |
Primary | Weight of Investigational Device | Product weight (amount of fluid absorbed) | within 1 hour of use of product |
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