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Intra-vaginal Diazepam for High Tone Pelvic Floor Dysfunction: A Randomized Placebo-Controlled Trial

Crisp, Catrina C, M.D.

Abstract Details

2013, MS, University of Cincinnati, Medicine: Clinical and Translational Research.
Introduction and Hypothesis: Intra-vaginal diazepam suppositories are commonly prescribed as a treatment option for high tone pelvic floor myalgia. This triple-blinded placebo-controlled randomized trial sought to determine if 10mg diazepam suppositories improve resting pelvic floor electromyography (EMG) as compared to placebo. Methods: Women ≥18 years of age diagnosed with hypertonic pelvic floor muscles on exam, confirmed by resting EMG ≥2.0 microvolts (µv), administered vaginal suppositories containing either diazepam or placebo for 28 consecutive nights. Outcomes included vaginal surface EMG (4 measurements), the Female Sexual Function Index (FSFI), the Short Form Health Survey 12 (SF-12), 4 visual analog scales (VAS), the Patient Global Impression of Severity (PGI-S), and the Patient Global Impression of Improvement (PGI-I). Our a priori sample size calculation indicated that 7 subjects in each group could detect a 2 µv difference in resting EMG tone with 90% power. Results: Twenty-one subjects were enrolled. The mean age was 36.1 (SD 13.9) years, mean body mass index (BMI) was 28.56 (SD 9.4), and the majority (85.7%) was Caucasian. When evaluating response to therapy, no difference was seen in any of the resting vaginal EMG assessments at any time point within subjects or between groups, nor was an interaction found. Additionally, no differences were noted in any of the validated questionnaire score. Conclusions: When used nightly over 4 weeks, vaginal diazepam was not associated with improvement in resting EMG parameters or subjective outcomes when compared to placebo. This suggests a lack of evidence for routine use of diazepam suppositories alone in treating high tone pelvic floor dysfunction.
Erin Nicole Haynes, Ph.D. (Committee Chair)
Steven D. Kleeman, MD FACOG (Committee Member)
Rachel Nicole Pauls, MD FRCSC FACOG (Committee Member)
26 p.

Recommended Citations

Citations

  • Crisp, M.D., C. C. (2013). Intra-vaginal Diazepam for High Tone Pelvic Floor Dysfunction: A Randomized Placebo-Controlled Trial [Master's thesis, University of Cincinnati]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1367926075

    APA Style (7th edition)

  • Crisp, M.D., Catrina. Intra-vaginal Diazepam for High Tone Pelvic Floor Dysfunction: A Randomized Placebo-Controlled Trial. 2013. University of Cincinnati, Master's thesis. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=ucin1367926075.

    MLA Style (8th edition)

  • Crisp, M.D., Catrina. "Intra-vaginal Diazepam for High Tone Pelvic Floor Dysfunction: A Randomized Placebo-Controlled Trial." Master's thesis, University of Cincinnati, 2013. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1367926075

    Chicago Manual of Style (17th edition)