Intravaginal Diazepam For The Treatment Of Pelvic Floor Hypertonic Disorder: A Double-Blind, Randomized, Placebo-Controlled Trial

Pelvic floor hypertonic disorder is a neuromuscular condition that causes involuntary spasms of the levator ani muscles, resulting in reproducible pelvic pain during vaginal intercourse or internal pelvic examination. It may act as a primary pain generator, a singular component of pelvic pain, or cause bladder or bowel dysfunction. The disorder is associated with numerous clinical syndromes. Several nonsurgical treatment options have been investigated. These include off-label use of intravaginal diazepam or botulinum toxin injection, as well as pelvic floor physical therapy and rehabilitation. Intravaginal diazepam has been studied as a viable alternative to traditional pelvic floor physical therapy and has been increasingly used off-label for this indication. However, efficacy data to support this or any treatment are limited.The aim of this a double-blind, placebo-controlled, randomized clinical trial was to determine the efficacy of intravaginal diazepam for the treatment of pelvic pain secondary to levator ani muscle spasm. Visual analog pain scale (VAS) pain scores in women with symptomatic pelvic floor hypertonic dysfunction assessed 4 weeks after treatment with diazepam and conservative therapy were compared with those in subjects receiving the standard conservative therapy alone. Standard conservative therapy consists of a psyllium-based bowel regimen, heat therapy, pelvic stretching, and Kegel exercises. Eligible women 18 years or olderwith symptomatic pelvic floor hypertonic dysfunction received self-administered intravaginal diazepamin addition to standard conservative therapy. Subjects were randomized to receive 10-mg diazepam capsules or identical-appearing placebo capsules. The primary study outcome was the change in pain assessed on a 100-mm VAS between baseline and 4 weeks. Secondary outcomes (sexual function, pain, and health-related quality of life) were assessed using validated questionnaires.A total of 49 women were randomized: 25 to diazepam and 24 to the placebo. Thirty-five women with complete data available for analysis returned for follow-up at 4 weeks: 19 in the diazepam group and 16 in the placebo group. After 4 weeks, no difference was found in VAS scores between the diazepam group and placebo group (50 vs 39 mm, respectively; P = 0.36). There were also no differences between treatment groups in the questionnaire scores.These data show that self-administered intravaginal diazepam does not reduce pain in a population of women with pelvic floor hypertonic disorder. Likewise, no improvements occur in the questionnaire scores. Future studies using larger numbers and longer-term follow-up may demonstrate some benefit from intravaginal diazepam in this population.