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临床试验/NCT03083262
NCT03083262已完成不适用

Retrospective Chart Review to Investigate an Association Between Vulvovaginal Atrophy and High Tone Pelvic Floor Dysfunction (HTPFD)

St. Louis University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
vulvovaginal atrophy

研究概览

简要总结

Dyspareunia, or painful intercourse, is one of the most commonly reported complaints in postmenopausal women. One common cause of dyspareunia is vaginal atrophy (VVA), which occurs in >50% of postmenopausal women. At the time of menopause, a lack of estrogen thins the vaginal mucosa and lessons lubrication, making sex painful. Some women with vaginal atrophy will also have high tone pelvic floor dysfunction (HTPFD) (also known as levator spasm). Successful treatment of the sexual pain requires treatment of both vaginal atrophy and HTPFD.

How often vaginal atrophy and HTPFD coexist has not been studied. In fact, the prevalence of HTPFD is unknown. This is most likely due to the fact that many clinicians are unaware of its existence or how to diagnose or treat it. Also, sexual symptoms tend to be underreported due to embarrassment or hesitation to seek care. HTPFD frequently coexists with other conditions that cause pain like vaginal atrophy, endometriosis or interstitial cystitis. Treatment includes treating both conditions. If only one is treated, then sexual pain is likely to continue. There are several available treatments for HTPFD that have been studied including physical therapy, botox and intravaginal diazepam.

This is an area where clinicians may be under treating a condition and limiting the possibility of restoring normal sexual function to many women. Treating only vaginal atrophy without appropriate evaluation and treatment of HTPFD leaves a cohort of women still struggling with sexual pain. With a better understanding of the relationship between HTPFD and vaginal atrophy, the investigators hope to bring awareness concerning the importance of treating both in restoring normal sexual function.

详细描述

This is a retrospective chart review that will be performed to identify all female patients in the electronic medical records with a diagnosis of vulvovaginal atrophy (VVA).

The records of these patients with VVA will be examined for demographics, symptoms, answers to standardized questionnaires ( e.g. Female Sexual Function Index - FSFI - that is routinely assessed during clinical evaluation), work-up, diagnosis, and/or treatment of high tone pelvic floor dysfunction (HTPFD). Symptoms of HTPFD include but are not limited to pelvic pressure or pain, and dyspareunia. These data will then undergo statistical analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosis of vulvovaginal atrophy (VVA)

排除标准

  • not meeting the inclusion criteria

结局指标

主要结局

vulvovaginal atrophy

时间窗: 3 months

Charts reviewed for HTPFD

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

Becky Lynn, MD

Principal Investigator

St. Louis University

研究点 (1)

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