23: 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. Adult women with complaints of pelvic pain, who were noted to have levator ani muscle spasm on physical examination, were approached for enrollment in a double-blind, placebo-controlled, randomized clinical trial. After informed consent, eligible participants were randomized to receive 10mg diazepam tablets (1 tablet, as needed, once to twice per day) or identical appearing placebo tablets. Medications were self-administered vaginally. The primary outcome was change in pain scores measured by a visual analog scale (VAS) at four weeks. PFDI-20, McGill Pain Questionnaire, and Global Response Assessment were similarly assessed as secondary outcomes. Participants were randomized by a computer-derived random number sequence performed by the investigational pharmacist. Patients, care-givers, and those assessing the outcomes were blinded to group assignment. In total, 49 women were randomized (25 in the diazepam arm and 24 in the placebo arm). At 4 weeks, 35 women had returned for follow up and had complete data to analyze. There was no difference in VAS between treatment groups. (50 vs 39, P = 0.36). There were also no differences noted in the questionnaire scores: PFDI-20 (P = 0.51), McGill pain score (P = 0.86), Global Response Assessment (P = 0.79). In women with pelvic pain and pelvic floor hypertonic disorder, intravaginal diazepam use did not promote symptom improvement.