Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder: A Double-blind, Randomized, Placebo-Controlled Trial

Abstract

(Abstracted from Female Pelvic Med Reconstr Surg 2019;25:76–81) 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.

Topical Therapy for Vulvodynia: A Review of the Literature

“…In an RCT by Crisp et al,43 in which patients with hypertonic pelvic floor muscles were treated with 10-mg diazepam suppositories or placebo nightly for 28 days, diazepam failed to produce a difference in pelvic floor tone, pain, or sexual function. Holland et al44 treated 35 patients with pelvic pain in the same manner, and again diazepam 10-mg suppositories failed to improve pain or other symptoms. In a retrospective study by Rogalski et al,45 26 patients were treated with high-tone pelvic floor dysfunction (80.7% had vestibulodynia) with 10-mg diazepam suppositories nightly for 30 days, in addition to pelvic floor physical therapy and intramuscular trigger point injections.…”

Evaluation and Treatment of Vulvodynia: State of the Science

“…Diazepam vaginal suppositories and tablets have been prescribed to treat vulvodynia 18 and vulvar pain related to hypertonic pelvic floor muscles. 11,[43][44][45] Studies conducted on the use of vaginal diazepam have targeted women with pelvic pain related to hypertonic pelvic floor muscles [46][47][48] but not specifically vulvodynia. There were 2 small-sample double-blind RCTs 46,47 of vaginal diazepam for hypertonic pelvic floor dysfunction that showed no reduction in vulvar pain.…”

“…11,[43][44][45] Studies conducted on the use of vaginal diazepam have targeted women with pelvic pain related to hypertonic pelvic floor muscles [46][47][48] but not specifically vulvodynia. There were 2 small-sample double-blind RCTs 46,47 of vaginal diazepam for hypertonic pelvic floor dysfunction that showed no reduction in vulvar pain. A third double-blinded RCT 48 of diazepam with intravaginal transcutaneous electrical nerve stimulation (TENS) versus placebo with TENS for PV also showed no reduction in vulvar pain but did show a significant reduction in dyspareunia.…”

A physiatrist's understanding and application of the current literature on chronic pelvic pain: a narrative review

“…Studies regarding their efficacy for pelvic hypertonicity and/or dysfunction are limited and show mixed results. 26 , 51 , 64 , 86 A study of 49 randomized women (25 in the diazepam arm and 24 in the placebo arm) showed no difference in scores between the treatment groups after 4 weeks (50 vs 39 mm, for diazepam and placebo, respectively; P = 0.36). 51 Contrastingly, a study of 21 women taking diazepam for a month showed a decrease from 5.9 to 2.2 in the average pain score.…”

“… 26 , 51 , 64 , 86 A study of 49 randomized women (25 in the diazepam arm and 24 in the placebo arm) showed no difference in scores between the treatment groups after 4 weeks (50 vs 39 mm, for diazepam and placebo, respectively; P = 0.36). 51 Contrastingly, a study of 21 women taking diazepam for a month showed a decrease from 5.9 to 2.2 in the average pain score. The small sample size of this study limits any widespread conclusions.…”