Diazepam Vaginal Suppositories for High Tone Pelvic Floor Dysfunction.
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | November 2010 |
| End Date: | December 2011 |
Diazepam Vaginal Suppositories as a Treatment Option for High Tone PElvic Floor Dysfunction: A Randomized Controlled Trial.
The purpose of this study is to determine whether vaginal diazepam suppositories are an
effective treatment of high tone pelvic floor dysfunction.
effective treatment of high tone pelvic floor dysfunction.
High tone pelvic floor dysfunction is a common cause of pelvic pain in females. It is thought
to be initiated by a sentinel event such as trauma, surgery, or vaginal delivery1. Currently,
treatment options include warm baths, stretching, physical therapy with myofascial therapy or
biofeedback, or pharmacologic therapy with oral amitriptyline or tiazadine2. Physical therapy
can be effective. However, it usually involves frequent visits to a specialized physical
therapist to undergo intravaginal treatments consisting of myofascial release, massage, or
biofeedback. We would like to find a treatment option for patients that would be effective
without the invasive and time consuming nature of physical therapy. It is known that diazepam
is a valid treatment option for disorders involving spasticity including spastic cerebral
palsy5 and tetanus. A literature search on diazepam and high tone pelvic floor dysfunction
revealed one paper. This study has an intrinsic flaw as it is a retrospective chart review,
and the results are confounded by concurrent physical therapy. They were, however, able to
find that patients treated with diazepam suppositories showed a significant improvement in
pelvic floor tone. They also assessed pain and sexual function, but these did not reach
statistical significance.
to be initiated by a sentinel event such as trauma, surgery, or vaginal delivery1. Currently,
treatment options include warm baths, stretching, physical therapy with myofascial therapy or
biofeedback, or pharmacologic therapy with oral amitriptyline or tiazadine2. Physical therapy
can be effective. However, it usually involves frequent visits to a specialized physical
therapist to undergo intravaginal treatments consisting of myofascial release, massage, or
biofeedback. We would like to find a treatment option for patients that would be effective
without the invasive and time consuming nature of physical therapy. It is known that diazepam
is a valid treatment option for disorders involving spasticity including spastic cerebral
palsy5 and tetanus. A literature search on diazepam and high tone pelvic floor dysfunction
revealed one paper. This study has an intrinsic flaw as it is a retrospective chart review,
and the results are confounded by concurrent physical therapy. They were, however, able to
find that patients treated with diazepam suppositories showed a significant improvement in
pelvic floor tone. They also assessed pain and sexual function, but these did not reach
statistical significance.
Inclusion Criteria:
- candidates from the Division of Urogynecology at Good Samaritan Hospital in
Cincinnati, OH
- aged 18-65
- high tone pelvic floor dysfunction
Exclusion Criteria:
- allergy to diazepam or any drug in the class of benzodiazepines
- current pelvic floor physical therapy
- pelvic surgery within the last 3 months
- current pregnancy, planning on pregnancy during the study period, or not sure if
pregnant
- regular benzodiazepine, muscle relaxant, or daily alcohol use
- history of alcohol or drug abuse
- contraindications to diazepam: hepatic or renal dysfunction, myasthenia gravis, acute
narrow angle glaucoma, severe respiratory insufficiency, sleep apnea
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