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OpenTrials
Completed

NCT Number: NCT03083262

High Tone Pelvic Floor Dysfunction

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.

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Key information

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

St. Mary's Health Center

St Louis, Missouri, 63117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of vulvovaginal atrophy (VVA)

Exclusion criteria

  • not meeting the inclusion criteria

Treatment and study plan

No intervention

Other

None, there is no intervention

Primary outcomes

  1. vulvovaginal atrophy

    Time frame: 3 months

    Charts reviewed for HTPFD

Sponsors and collaborators

Lead sponsor

St. Louis University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2017
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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