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NCT03083262 · ClinicalTrials.gov registry record
High Tone Pelvic Floor Dysfunction
A clinical trial, sponsored by St. Louis University.
- Completed
- Registry status
- 80
- Enrollment target
NCT03083262: Completed study, sponsored by St. Louis University.
NCT03083262 is a clinical trial that has completed, run by St. Louis University. The registered enrollment target is 80 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03083262 has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- 80 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Charts reviewed for HTPFD
Interventions
- OTHER no intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2017-02-01 |
What the finished NCT03083262 record still lists
NCT03083262 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which no intervention is the first listed.
NCT03083262 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03083262 about?
NCT03083262 is a clinical study titled "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 lub...
What is the current status of trial NCT03083262?
This trial is currently completed. The enrollment target is 80 participants. The study started on 2017-01-31. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT03083262?
The interventions under investigation include: no intervention (OTHER).
Who is sponsoring clinical trial NCT03083262?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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