Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

Dyspareunia Clinical Trial

Official title:

Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04885556
• Other study ID #: AC-004
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: May 2021
• Source: Atlantic Health System
• Contact: Cynthia Evaniecki
• Phone: 973-537-5557
• Email: cevaniecki[@]gsunj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Vaginoses
• Dyspareunia
• Female Sexual Dysfunction
• Vaginal Discharge
• Vaginitis
• Vaginosis, Bacterial

Intervention

Device:
• Tampon-like device for absorption of sexual fluids
Subjects will insert a tampon-like device to absorb sexual fluids after intercourse

Locations

Country	Name	City	State
United States	The Center for Specialized Women's Health, division of Garden State Urology	Denville	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Atlantic Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Global Impression of Improvement (PGI-I)	Validated Questionnaire	within 1 hour of use of product
Primary	Weight of Investigational Device	Product weight (amount of fluid absorbed)	within 1 hour of use of product