Postcoital Vaginal Changes, Vaginal Discharge
Conditions
Keywords
tampon device, postcoital, vaginal mucosa, device safety, sexual intercourse, pelvic exam
Brief summary
The goal of this clinical trial is to learn if the Livi postcoital tampon device is safe for repetitive use in sexually active women aged 18 years and older. The main question it aims to answer is: Does using the Livi device three times in a row cause any visible vaginal mucosal trauma? How much pain or discomfort do participants experience during insertion and removal? Researchers will not compare the Livi device to another product because this is a single-arm safety study. Participants will: * Insert and remove the Livi device three times consecutively during one clinic visit * Undergo a baseline speculum exam and digital colposcopy exams after each device removal to check vaginal tissue * Complete a 24-hour follow-up via e-diary or phone call to report pain, spotting, or other symptoms * Report any unsolicited symptoms for 7 days after use
Interventions
DEVICELivi Postcoital Tampon Device
Single-use polyurethane foam pledget inserted via disposable applicator, designed to absorb semen post-intercourse.
Sponsors
Atlantic Health System
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Sexually active women aged ≥18 years * Able and willing to comply with all study procedures * Able to provide written informed consent
Exclusion criteria
* Current pregnancy or within 6 weeks postpartum * Symptomatic vaginal infection, lesion, or vulvovaginal discomfort at baseline * Known allergy to any component of the study device * Pelvic or vaginal surgery within the past 6 weeks * Any medical or psychological condition that, in the investigator's opinion, may interfere with participation or safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade ≥2 vaginal mucosal trauma | Immediate post-use (within 5 minutes of device removal) | Incidence of Grade ≥2 vaginal mucosal trauma assessed immediately after device removal via digital colposcopic examination. Mucosal trauma defined as: Grade 2 (Moderate): Abrasion \>5 mm or multiple foci totaling \>10 mm; pinpoint bleeding stopping spontaneously. Grade 3 (Severe): Laceration or bleeding requiring medical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Spotting or pain within 24 hours post-use | 24-hour (+/- 6hr) follow-up | self-reported by subject on e-diary or telephone survey |
| Pain/discomfort during insertion/removal | During Visit 1, immediately after device insertion/removal, and at 24-hours (+/- 6 hr) | Immediately after device insertion and removal, Numeric Rating Scale (0- no pain to 10- maximum pain) will be self-reported by patient. |
| Ease of use | During Visit 1 immediately following third device insertion | Likert scale on ease of overall device use - Very Easy, Easy, Neither Easy Nor Difficult, Difficult, Very Difficult |
| Allergy and Hypersensitivity Responses | after each study device removal, and up to 7 days following visit 1 | Mucosal changes consistent with allergy or hypersensitivity (eg edema, urticaria, swelling, itching) will be documented - this will be both reported subjectively by the patient, and objectively reported by the clinician using digital colposcopy examinations. |
Countries
United States
Outcome results
None listed