and with placebo in a randomized, double-blind, placebo-controlled trial.
In the TENS/diazepam and TENS/placebo groups, participants reported significant improvements from baseline in pain and sexual functioning by questionnaire and visual analog scale. They also improved in measurements of pelvic floor muscle tone and vestibular nerve fiber current perception threshold.
The study had two groups of 21 women each, all aged 18 years or older and diagnosed (by physical exam) with moderate or severe pelvic floor hypertonic dysfunction. The diazepam was a tablet inserted vaginally daily before bed.
The TENS therapy was also self-administered (after six or seven supervised trial sessions), a recommended three times per week. The device is a 20-mm diameter plastic vaginal probe with gold metallic transversal rings as electrodes, inserted 20 mm, with 30 minutes of electrical stimulation increased slowly until sensation “reached a level described as the maximum tolerable without experiencing pain.” Vulvar pain was assessed on a on a 10-cm visual analog scale and dyspareunia on the Marinoff dyspareunia scale.
At the primary endpoint, the mean change from baseline to 60 days, the diazepam combination improved from 7.5 on the visual scale to 4.7, while the placebo combination improved from 7.2 to 4.3 (P not significant between the groups). Marinoff dyspareunia scores, however, improved from 2.5 to 1.6 and from 2.0 to 1.3, respectively (P less than .01).
Though “very few statistically significant differences in outcomes between the two groups were observed ... our results indicate that diazepam is able to positively change the functions of the pelvic floor muscle often highlighted” in women with vestibulodynia, reported Filippo Murina, MD, of the University of Milan and his coauthors. This conclusion followed from the Marinoff scores and from vaginal surface electromyography. In the latter measure, the diazepam group showed a significantly greater ability to relax the pelvic floor muscle after contraction (3.8 vs. 2.4 microvolts; P = .01), compared with the placebo group.
“We also observed that TENS itself is essential in reducing vulvar pain and the action of diazepam is useful but not decisive. ... It is possible that vaginal diazepam alone is insufficient to resolve the symptoms related to pelvic floor muscle dysfunction, while vaginal diazepam and TENS together provide a synergistic benefit in vestibulodynia patients,” wrote Dr. Murina and his coauthors.
This study was supported by the Associazione Italiana Vulvodinia. The authors declared no conflicts of interest.
SOURCE: Murina F et al. Eur J Obstet Gynecol Reprod Biol. 2018 Jun;228:148-53.