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临床试验/NCT04885556
NCT04885556Unknown不适用

Evaluation of a Novel Female Hygiene Device for Postcoital Discomfort

Atlantic Health System2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年4月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
2
主要终点
Patient Global Impression of Improvement (PGI-I)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Patient Global Impression of Improvement (PGI-I)

时间窗: within 1 hour of use of product

Validated Questionnaire

Weight of Investigational Device

时间窗: within 1 hour of use of product

Product weight (amount of fluid absorbed)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Ingber

Director of The Center for Specialized Women's Health, division of Garden State Urology/Atlantic Health System

Atlantic Health System

研究点 (2)

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