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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sexual Dysfunction; Vaginal Discharge; Vaginal Infection; Vaginosis
• Intervention / Treatment: Device: LiviWell Postcoital Vaginal Insert

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 Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Mountain Lakes, New Jersey, United States, 07046
      • Garden State Urology
      • Principal Investigator: Michael Ingber, MD
      • Contact: Cathy Smith, MA; Phone Number: 973-537-5557; Email: csmith@gsunj.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pH subset; This subset of patients (n=100) will be checking their vaginal pH at various time intervals (before, 2-6 hours after, and 10-14 hours after sex).	Device: LiviWell Postcoital Vaginal Insert; subjects will use Livi within minutes of completion of sex, and will remove study device in under an hour.; Other Names: Livi
Experimental: Main Cohort; This subset of patients (n=900) will be providing user feedback on the study device, and will not be checking their vaginal pH	Device: LiviWell Postcoital Vaginal Insert; subjects will use Livi within minutes of completion of sex, and will remove study device in under an hour.; Other Names: Livi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
User Experience Questionnaire	Validation of User Needs Requirements as well as patient experience	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in vaginal pH	change in vaginal pH before and after using Livi, and before and after NOT using Livi	2-6 hours, and 10-14 hours after use

Collaborators and Investigators

• Sponsor: Atlantic Health System

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: July 27, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: vaginal discharge; vaginal microbiome; vaginal odor; postcoital dripping
• Additional Relevant MeSH Terms: Vaginal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vaginal Discharge
• Other Study ID Numbers: AC-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No