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Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder

A Double-Blind, Randomized, Placebo-Controlled Trial

Holland, Michael A., DO*; Joyce, John S., MD; Brennaman, Lisa M., MD*; Drobnis, Erma Z., PhD*; Starr, Julie A., APRN, PhD*; Foster, Raymond T. Sr, MS, MD, MHSc*

Female Pelvic Medicine & Reconstructive Surgery: January/February 2019 - Volume 25 - Issue 1 - p 76–81
doi: 10.1097/SPV.0000000000000514
Original Articles
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Objectives Pelvic floor hypertonic disorder is characterized by an involuntary spasm of the levator ani muscles and is associated with several clinical syndromes. Several treatment options have been described; however, treatment efficacy data are limited. The objective of this study was to determine the efficacy of intravaginal diazepam for the treatment of pelvic pain secondary to levator ani muscle spasm in comparison to placebo.

Methods 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. Eligible participants were randomized to receive 10-mg diazepam capsules or identical-appearing placebo capsules. The primary outcome was the change in pain scores measured by a 100-mm visual analog scale at 4 weeks. Several validated questionnaires were similarly assessed as secondary outcomes.

Results In total, 49 women were randomized (25 in the diazepam arm and 24 in the placebo arm). At 4 weeks, 35 women returned for follow-up and had complete data available analysis. There was no difference in visual analog scale scores between the treatment groups after 4 weeks (50 vs 39 mm, for diazepam and placebo, respectively; P = 0.36). There were also no differences noted in the questionnaire scores.

Conclusions It is unlikely that self-administered intravaginal diazepam suppositories promote an improvement in the 100-mm visual analog scale of 20 mm or more or other substantial symptom improvement in women with pelvic floor hypertonic disorder.

Intravaginal diazepam failed to show an improvement in visual analog scale pain scores after 4 weeks of treatment in women with pelvic floor hypertonic disorder.

From the *Department of Obstetrics, Gynecology, and Women's Health, University of Missouri Health Care, Columbia, MO; and

Department of Obstetrics and Gynecology, Baylor Scott & White Health, Temple, TX.

The authors have declared they have no conflicts of interest.

Clinical Trial: NCT01938092, https://clinicaltrials.gov/ct2/show/NCT01938092.

Source of funding: This trial was funded by the primary investigator's departmental research funds.

Correspondence: Raymond T. Foster, Sr, MS, MD, MHSc, 500 N. Keene Street, Suite 306, Columbia, MO 65201. E-mail: FosterRT@health.missouri.edu.

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