Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
NCT ID: NCT04885556
Last Updated: 2021-05-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-04-05
2021-09-15
Brief Summary
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Detailed Description
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Previous studies have shown the effects of semen on alterations in the vaginal flora. These changes contribute to a multitude of clinical complaints and diagnoses, including malodor, continuous discharge after intercourse, and bacterial vaginosis (BV). The exposure of semen changes the vaginal flora by increasing the pH levels, in turn altering the bacterial growth pattern. This implies the persistent presence of semen in the vagina may be one of the causes of malodor and development of BV. Chvapil utilized gas chromatography and demonstrated that the longer period of time semen was present in the vagina, the more likely it resulted in a strong and unattractive vaginal odor. Gallo showed that an incidental diagnosis of BV was correlated with detection of sperm on gram stain, and frequent coitus with or without condom use.
The investigator's goal in this study is to evaluate a novel postcoital consumer health product and its effects on the complaints of continuous seepage of semen and vaginal odor after intercourse.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate Use
Subjects in this arm will be instructed to use the study device for 2 minutes and remove
Tampon-like device for absorption of sexual fluids
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse
1 hour use
Subjects in this arm will be instructed to use the product for one hour and then remove
Tampon-like device for absorption of sexual fluids
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse
Interventions
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Tampon-like device for absorption of sexual fluids
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
50 Years
FEMALE
Yes
Sponsors
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Atlantic Health System
OTHER
Responsible Party
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Michael Ingber
Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System
Locations
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The Center for Specialized Women's Health, division of Garden State Urology
Denville, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Role: backup
Other Identifiers
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AC-004
Identifier Type: -
Identifier Source: org_study_id
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