Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

May 8, 2021 updated by: Michael Ingber, Atlantic Health System
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 into the vagina after intercourse to absorb semen deposited into the vaginal canal to determine if there is a reduction in dripping and odor, and to determine the amount of fluids absorbed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 recently approved medical therapies for hypoactive sexual desire disorder, physicians have begun to adapt to questioning patients about libido and pain-related sexual dysfunctions. However, pain-related sexual questionnaires often focus on insertional and penetrational dyspareunia, without asking about discomfort minutes, hours, or even the day following sexual intercourse. One common compliant in ambulatory sexual medicine clinics is the bothersome dripping, odor, and discomfort women experience after sexual activity when no condom is used, and when intravaginal ejaculation occurs.

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Denville, New Jersey, United States, 07834
        • Recruiting
        • The Center for Specialized Women's Health, division of Garden State Urology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Intber, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Immediate Use
Subjects in this arm will be instructed to use the study device for 2 minutes and remove
Device: Tampon-like device for absorption of sexual fluids
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse
EXPERIMENTAL: 1 hour use
Subjects in this arm will be instructed to use the product for one hour and then remove
Device: Tampon-like device for absorption of sexual fluids
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Global Impression of Improvement (PGI-I)
Time Frame: within 1 hour of use of product
Validated Questionnaire
within 1 hour of use of product
Weight of Investigational Device
Time Frame: within 1 hour of use of product
Product weight (amount of fluid absorbed)
within 1 hour of use of product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atlantic Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 5, 2021

Primary Completion (ANTICIPATED)

September 15, 2021

Study Completion (ANTICIPATED)

September 15, 2021

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

May 8, 2021

First Posted (ACTUAL)

May 13, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 13, 2021

Last Update Submitted That Met QC Criteria

May 8, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-004

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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