Tuesday, September 11, 2012

Vaginal Diazepam Use With Urogenital Pain/Pelvic Floor Dysfunction Serum Diazepam Levels and Efficacy Data

Clinicians are often challenged to find efficacious treatments for patients with pelvic floor dysfunction pain, PBS/IC, or vulvar pain. Current treatment options include neuropathic analgesics, other analgesics, antidepressants, antihistamines, opioids, behavioral modification, physical therapy, intravesical therapies, complementary therapies, and neuromodulation (Fall et al., 2010). Due to the visceral nature of this pain (Butrick, 2009), it is often difficult to identify a specific source for the pain. Presenting symptoms are often treated, often without further assessment, for a possible underlying trigger. Pelvic floor dysfunction is present in over 70% of those with PBS/IC or dysfunctional voiding symptoms (Butrick, 2009), and perhaps therapies to target this hypertonic pelvic floor should be a first line of treatment.
To date it is unknown if localized vaginally administered muscle-relaxing agents are efficacious in treating the underlying PFD in PBS/IC, vulvar pain, and even vaginismus contributing to dyspareunia. This preliminary clinical data report provides insight into a possible alternative treatment for these conditions. Significant limitations of this report include a small sample size with either vulvar pain and/or levator pain who agreed to off-label treatment with vaginal diazepam. These women were a selected sample of women who had failed to respond to a variety of previous therapies. Additionally, the home recording form (see Figure 2) has not been validated or tested for reliability. This limits any widespread conclusions that can be drawn from these results. Although the sample size is small, perhaps the noted number of responders to treatment (13/21) without serious adverse effects merits consideration for a larger randomized controlled trial.
However, it appeared that daily doses three times a day of up to 10 milligrams of diazepam does not cause elevated serum levels after one month of therapy. These clinical data show that serum levels were in a safe range, and that off-label vaginal diazepam may be helpful to treat these symptoms. Since this was a clinical practice population and not a controlled trial, patients did not have a set time to have their serum level done after their last dose of diazepam. There is no current published protocol, but it seems prudent to monitor for adverse side effects, adjust dosage or compounded drug as needed, and evaluate serum levels on a monthly basis with regular diazepam use. Further study should include voiding diaries and pain levels to assess the impact on voiding dysfunction symptoms.
Vaginal diazepam appears to be a potentially useful off-label therapy for women with pelvic floor dysfunction pain-related symptoms, PBS/IC, or vulvodynia. However, further research using a randomized, placebocontrolled trial needs to be done to evaluate the true efficacy and safety of this therapy.

Donna J. Carrico, MS, WHNP; Kenneth M. Peters, MD
Posted: 12/26/2011; Urol Nurs. 2011;31(5):279-284. © 2011 Society of Urologic Nurses and Associates



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