Status:
UNKNOWN
Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
Lead Sponsor:
Atlantic Health System
Conditions:
Vaginal Discharge
Dyspareunia
Eligibility:
FEMALE
25-50 years
Phase:
NA
Brief Summary
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 int...
Detailed Description
Despite the significant number of sexual dysfunctions in women, physicians often avoid discussing these concerns in the office setting. With recent research on the role of the pelvic floor, and recent...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04885556
Start Date
April 5 2021
End Date
September 15 2021
Last Update
May 13 2021
Active Locations (1)
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1
The Center for Specialized Women's Health, division of Garden State Urology
Denville, New Jersey, United States, 07834