Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

• Sponsor: Atlantic Health System (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04885556
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.4
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Discharge; Dyspareunia; Female Sexual Dysfunction; Vaginitis; Bacterial Vaginoses	Device: Tampon-like device for absorption of sexual fluids	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects to be placed into one of two study groups, 1) immediate use and 2) 1 hour useSubjects to be placed into one of two study groups, 1) immediate use and 2) 1 hour use
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort
• Actual Study Start Date: Apr 5, 2021
• Anticipated Primary Completion Date: Sep 15, 2021
• Anticipated Study Completion Date: Sep 15, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient Global Impression of Improvement (PGI-I) [within 1 hour of use of product]

   Validated Questionnaire

2. Weight of Investigational Device [within 1 hour of use of product]

   Product weight (amount of fluid absorbed)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Center for Specialized Women's Health, division of Garden State Urology	Denville	New Jersey	United States	07834

Sponsors and Collaborators

• Atlantic Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Ingber, Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System, Atlantic Health System
• ClinicalTrials.gov Identifier: NCT04885556
• Other Study ID Numbers: AC-004
• First Posted: May 13, 2021
• Last Update Posted: May 13, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Michael Ingber, Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System, Atlantic Health System: vaginal discharge; dripping; vaginal odor
• Additional relevant MeSH terms: Vaginosis, Bacterial; Vaginitis; Dyspareunia; Vaginal Discharge

Study Results

No Results Posted as of May 13, 2021