Skip to main content

Intra-vaginal diazepam for high-tone pelvic floor dysfunction: a randomized placebo-controlled trial


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 10 mg diazepam suppositories improve resting pelvic floor electromyography (EMG) compared with placebo.


Women ≥18 years of age with hypertonic pelvic floor muscles on examination, 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 (four measurements), the Female Sexual Function Index (FSFI), the Short Form Health Survey 12 (SF-12), four visual analog scales (VAS), the Patient Global Impression of Severity (PGI-S), and the Patient Global Impression of Improvement (PGI-I). 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.


Twenty-one subjects were enrolled. The mean age was 36.1 (SD 13.9) years, mean body mass index 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 questionnaires.


When used nightly over 4 weeks, 10 mg of vaginal diazepam was not associated with improvement in resting EMG parameters or subjective outcomes compared with placebo. This suggests such that therapy alone may be insufficient in treating high-tone pelvic floor dysfunction.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2
Fig. 3


  1. Rogalski MJ, Kellog-Spadt S, Hoffmann AR, Fariello JY, Whitmore KE (2010) Retrospective chart review of vaginal diazepam suppository use in high-tone pelvic floor dysfunction. Int Urogynecol J 21:895–899

    PubMed  Article  Google Scholar 

  2. Lukban J, Whitmore K, Kellog-Spadt S, Bologna R, Lesher A, Fletcher E (2001) The effect of manual physical therapy in patients diagnosed with interstitial cystitis, high-tone pelvic floor dysfunction, and sacroiliac dysfunction. Urology 57 [6 Suppl 1]:121–122

    Article  CAS  Google Scholar 

  3. Oyama IA, Rejba A, Lubkan JC, Fletcher E, Kellog-Spadt S, Holzberg AS, Whitmore KE (2004) Modified Thiele massage as therapeutic intervention for female patients with interstitial cystitis and high-tone pelvic floor dysfunction. Urology 64:862–865

    PubMed  Article  Google Scholar 

  4. Ger GC, Wexner SD, Jorge JM, Salanga VD (1993) Anorectal manometry in the diagnosis of paradoxical puborectalis syndrome. Dis Colon Rectum 36:816–825

    PubMed  Article  CAS  Google Scholar 

  5. Rapkin AJ, Kames LD (1987) The pain management approach to chronic pelvic pain. J Reprod Med 32:323–327

    PubMed  CAS  Google Scholar 

  6. Srinivasan AK, Kaye JD, Moldwin R (2007) Myofascial dysfunction associated with chronic pelvic floor pain: management strategies. Curr Pain Headache Rep 11:359–364

    PubMed  Article  Google Scholar 

  7. Wiegel M, Meston C, Rosen R (2005) The female sexual function index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther 31:1–20

    PubMed  Article  Google Scholar 

  8. Ware J Jr, Kosinski M, Keller SD (1996) A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care 34:220–233

    PubMed  Article  Google Scholar 

  9. Von Korff M, Deyo RA, Cherkin D, Barlow W (1993) Back pain in primary care. Outcomes at 1 year. Spine (Phila Pa 1976) 18:855–862

    Article  Google Scholar 

  10. Yalcin I, Bump RC (2003) Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol 189:98–101

    PubMed  Article  Google Scholar 

  11. Srikrishna S, Robinson D, Cardozo L (2010) Validation of the Patient Global Impression of Improvement (PGI-I) for urogenital prolapse. Int Urogynecol J 21:523–528

    PubMed  Article  Google Scholar 

  12. Kotarinos RK (2003) Pelvic floor physical therapy in urogynecologic disorders. Curr Womens Health Rep 3:334–339

    PubMed  Google Scholar 

  13. Glazer HI, Jantos M, Hartmann EH, Swencionis C (1998) Electromyographic comparisons of the pelvic floor in women with dysesthetic vulvodynia and asymptomatic women. J Reprod Med 43:959–962

    PubMed  CAS  Google Scholar 

  14. White G, Jantos M, Glazer H (1997) Establishing the diagnosis of vulvar vestibulitis. J Reprod Med 42:157–160

    PubMed  CAS  Google Scholar 

  15. Wehbe SA, Whitmore K, Kellogg-Spadt S (2010) Urogenital complaints and female sexual dysfunction (part 1). J Sex Med 7:1704–1713, quiz 1703, 1714–1715

    PubMed  Article  Google Scholar 

  16. Thiele GH (1963) Coccygodynia: cause and treatment. Dis Colon Rectum 6:422–436

    PubMed  Article  CAS  Google Scholar 

  17. Langford CF, Udvari Nagy S, Ghoniem GM (2007) Levator ani trigger point injections: an underutilized treatment for chronic pelvic pain. Neurourol Urodyn 26:59–62

    PubMed  Article  Google Scholar 

  18. Cram JR (1998) Cram’s introduction to surface electromyography. Jones and Bartlett, Sudbury

    Google Scholar 

Download references


The authors would like to thank Vivian Ghodsi RN, CCRC, for her valuable help with patient screening, data collection, and subject follow-up for this study.


This study was funded by an education grant through the TriHealth Medical Education Research Fund.

Conflict of interest


Author information

Authors and Affiliations


Corresponding author

Correspondence to Catrina C. Crisp.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Crisp, C.C., Vaccaro, C.M., Estanol, M.V. et al. Intra-vaginal diazepam for high-tone pelvic floor dysfunction: a randomized placebo-controlled trial. Int Urogynecol J 24, 1915–1923 (2013).

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI:


  • High-tone pelvic floor dysfunction
  • Levator myalgia
  • Pelvic floor tension myalgia
  • Randomized trial
  • Vaginal diazepam