Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters

Not Applicable

Not yet recruiting

• Conditions: Vaginal Discharge; Vaginosis; Vaginal Infection; Sexual Dysfunction

• Registration Number: NCT06530186
• Lead Sponsor: Atlantic Health System

Brief Summary

LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.

Detailed Description

LiviWell's consumer hygiene device is a post-coital vaginal insert called "Livi". Livi is comprised of an applicator, with a medical-grade polyurethane foam and retrieval string. It is designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal. The result is a decrease in discharge/dripping and vaginal odor. The investigators also believe the device will lower vaginal pH, as the typical premenopausal vaginal pH is acidic (pH \~4), and semen has an alkaline pH (\~8). The resulting pH imbalance in sexually-active women not using male condoms had been shown to lead to vaginal odor, dripping, discomfort. Furthermore, the risk of bacterial vaginosis (BV) is higher in women who are sexually active and not using male condoms. The investigators have additional studies planned to evaluate if the product lowers the risk of BV.

The current study will be used to validate user needs requirements for the study device, understand pH changes after insertion, and evaluate change in symptoms of vaginal odor, discharge/dripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-27
• Study First Submitted QC: 2024-07-27
• Last Update Submitted: 2024-07-27
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Study Start: 2024-08-01
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Over 18 (for pH subset, 18-45)
• Sexually-active with biological men
• Willing and able to use product
• Resides in continental USA
• Understands, reads, writes, and speaks English

Exclusion Criteria

• Currently Pregnant or are trying to conceive
• Unable to use device due to poor motor function
• Unable to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
User Experience Questionnaire	24 hours	Validation of User Needs Requirements as well as patient experience

Secondary Outcome Measures

Name	Time	Method
change in vaginal pH	2-6 hours, and 10-14 hours after use	change in vaginal pH before and after using Livi, and before and after NOT using Livi

Trial Locations

Locations (1)

Garden State Urology; 🇺🇸 Mountain Lakes, New Jersey, United States