Vaginal Diazepam for the Treatment of Female Pelvic Pain
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/27/2017 |
| Start Date: | September 2013 |
| End Date: | July 2017 |
Intravaginal Diazepam for the Treatment of Pelvic Pain Among Women With Pelvic Floor Hypertonic Disorder: a Double Blind, Randomized, Placebo Controlled Trial
To determine the efficacy of intravaginal diazepam for the treatment of pelvic pain
associated with pelvic floor hypertonic disorder.
associated with pelvic floor hypertonic disorder.
Women who are asked to participate will already be receiving a standard conservative therapy
consisting of a psyllium-based bowel regimen, heat therapy, pelvic stretching exercises, and
Kegel exercises. Participants will randomly be assigned by a computer-derived random number
sequence (after pregnancy is ruled out) to either the treatment group (intravaginal diazepam)
or the placebo group Investigators and patients will be blinded to group assignment. The
placebo or diazepam tablet will be distributed to the participant in the examining room on
the day of allocation. The participant will be instructed to insert the diazepam or placebo
tablet into her vagina at home. The treatment group will insert the diazepam 10 mg vaginal
tablet 1-2 times daily as needed in addition to the standard conservative therapy. The
placebo group will receive the standard conservative therapy, and an intravaginal tablet
(visually indistinguishable from diazepam) commercially produced by the university pharmacy.
After 4 weeks, patients from either group will have the option of enrolling into a standard
routine program (not research) of comprehensive pelvic floor rehabilitation therapy. The
Visual Analog Pain Scale, Pelvic Floor Distress Inventory-20 Questionnaire, McGill Pain
Questionnaire and Global Response Assessment will be completed by the participant at the
initial visit, 4 weeks, 8 weeks and 12 weeks. Participants will be given the option of
choosing one or more methods for returning questionnaires: electronic mail, self-addressed
home envelope, or telephone call.
consisting of a psyllium-based bowel regimen, heat therapy, pelvic stretching exercises, and
Kegel exercises. Participants will randomly be assigned by a computer-derived random number
sequence (after pregnancy is ruled out) to either the treatment group (intravaginal diazepam)
or the placebo group Investigators and patients will be blinded to group assignment. The
placebo or diazepam tablet will be distributed to the participant in the examining room on
the day of allocation. The participant will be instructed to insert the diazepam or placebo
tablet into her vagina at home. The treatment group will insert the diazepam 10 mg vaginal
tablet 1-2 times daily as needed in addition to the standard conservative therapy. The
placebo group will receive the standard conservative therapy, and an intravaginal tablet
(visually indistinguishable from diazepam) commercially produced by the university pharmacy.
After 4 weeks, patients from either group will have the option of enrolling into a standard
routine program (not research) of comprehensive pelvic floor rehabilitation therapy. The
Visual Analog Pain Scale, Pelvic Floor Distress Inventory-20 Questionnaire, McGill Pain
Questionnaire and Global Response Assessment will be completed by the participant at the
initial visit, 4 weeks, 8 weeks and 12 weeks. Participants will be given the option of
choosing one or more methods for returning questionnaires: electronic mail, self-addressed
home envelope, or telephone call.
Inclusion Criteria:
- Age 18 years old
- Primary complaint of acute or chronic pelvic pain with or without dyspareunia
- Physical exam findings consistent with levator muscle spasm
- Capable of inserting tablet in vagina without use of applicator.
Exclusion Criteria:
- Chronic narcotic use
- Non-English speaking
- Currently serving a prison sentence
- Stage III or greater vaginal prolapse
- Allergies or contraindications to benzodiazepines
- Pregnant or breastfeeding
- Currently receiving comprehensive pelvic floor rehabilitation therapy and/or vaginal
valium therapy
- Unwilling or incapable of inserting tablet in vagina without applicator.
We found this trial at
1
site
Columbia, Missouri 65201
Phone: 573-817-3165
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