Vaginal Diazepam Use With Urogenital Pain/Pelvic Floor Dysfunction

Serum Diazepam Levels and Efficacy Data

Donna J. Carrico, MS, WHNP; Kenneth M. Peters, MD


Urol Nurs. 2011;31(5):279-284. 

In This Article


This IRB-approved clinical database study included 21 women ages 22 to 61 (mean = 40) receiving care in a clinic that specializes in female pelvic pain, previously diagnosed PBS/IC, vulvodynia, and female sexual function concerns. Women are referred by their health care providers or may self-refer to the clinic. Women with vulvar pain on their Q-Tip® examination or with levator pain on examination who were treated with off-label vaginal diazepam were included in this dataset. All women were evaluated by the same clinician at the first visit and one month after being treated with vaginal diazepam. The evaluation included a complete history and pelvic examination composed of a vulvar cotton swab examination (at the 1, 3, 5, 7, 9, and 11 o'clock positions around the vaginal opening at Hart's line), a vaginal bimanual examination, and levator assessment (pressing the index finger laterally during the vaginal examination to assess the levator muscles for spasms or trigger points measured on a 0 to 10-point scale). These women had been refractory to other therapies previously prescribed, including opioids, topical preparations (formulary and compounded), PBS/IC therapies (medications, instillations, dietary, and behavioral modifications), antiepileptics, and antidepressants. Since this was a clinic population, the use of other treatments was not standardized to all patients.

Options for care were discussed, and off-label use of vaginal diazepam was explained. Risks, benefits, potential side effects to the patient, and sexual partner were discussed. With the patient's informed verbal consent, vaginal diazepam 2 to 10 milligrams (as needed for symptom relief) was ordered to be used up to every 8 hours as needed. The usual starting dosage was 5 milligrams unless the woman expressed greater sensitivity to the effect of most medications. If this was the case, the dosage of off-label vaginal diazepam was started at 2 milligrams. If there was no relief with 5 milligrams after 7 to 10 days of treatment, the dosage was increased to 10 milligrams if tolerated. The option to compound the diazepam into a vaginal cream or suppository was offered to patients, and all decided to try the oral tablet vaginally first. The oral tablet was ordered, and patients were instructed to insert it into the vagina either whole or to crush it and insert it mixed in vaginal lubricant. The women recorded their weekly vaginal diazepam dose, frequency of use, pain score (10-point VAS), and any adverse effects once a week on the same day for one month. At that time, a serum diazepam level was done on those 15 women using vaginal diazepam at least daily; a pelvic examination on all women was done by the same clinician.


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