Dyspareunia
Conditions
Keywords
Pelvic Floor Myalgia, Trigger Point Injections, Pelvic Rehabilitation, Dyspareunia
Brief summary
The purpose of this study is to evaluate which treatment option for pelvic floor pain allows for improved sexual function.
Detailed description
Pelvic floor pain may be treated with trigger point injections with medications (steroids and local anesthetics) that are FDA approved for injection into muscles. The alternative is a noninvasive treatment option using pelvic rehabilitation which involves vaginal muscle massage. Both treatment options have been used and reported; however, rapidity of improvement and return to normal sexual function have not been assessed. This study assigns patients to either treatment option randomly and the sexual function is assessed based on standardized sexual function questionnaires as well as pain ratings.
Interventions
DRUGTrigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride
The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature.
PROCEDUREPelvic Rehabilitation
Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy
Sponsors
Patty Brisben Foundation For Women's Sexual Health
University of Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pelvic pain * pelvic floor myalgia * dyspareunia * female * age \> 18 years
Exclusion criteria
* interstitial cystitis * vaginal lesions / ulcerations * prior trigger point injections in the past 6 months * prior pelvic rehabilitation in the past 6 months * laparoscopically documented endometriosis / pelvic adhesions or adhesive disease * documented pelvic inflammatory disease identified within the past 6 months * documented sexually transmitted disease within the past 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in rating of pain from baseline until the end of the study according to the Iowa Pain Scale | Baseline, Week 10 | Patients will be asked to rate their current pain prior to initiation of the treatment at the visits, at the start of the study and after the completion of the study, using the 10 point Iowa Pain scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in sexual function between visit 1 and visit 10 | Baseline, Week 10 | Change in sexual function based on the female sexual function index (19 questions, one final score, maximum score of 36) where the patients fill a questionnaire prior to the first treatment session and after the completion of the treatment at week 10. |
Countries
United States
Contacts
Primary ContactDani Zoorob, MD
Backup ContactMary South, MD
Outcome results
None listed