NCT04885556

Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Atlantic Health System · Academic / Other
• Sex: Female
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Tampon-like device for absorption of sexual fluids	Subjects will insert a tampon-like device to absorb sexual fluids after intercourse

Timeline

• Start date: 2021-04-05
• Primary completion: 2021-09-15
• Completion: 2021-09-15
• First posted: 2021-05-13
• Last updated: 2021-05-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study