Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis
Status:
Completed
Trial end date:
2014-09-01
Target enrollment:
Participant gender:
Summary
The primary objective of this prospective, randomized, controlled study is to assess the
effect of Trimo-San vaginal gel on the rate of bacterial vaginosis in women who use
pessaries. Women being fitted for a pessary for the first time or not wearing a pessary for
>1 year are recruited in to the study and randomized to using Trimo-San gel daily or not
using Trimo-San gel. The investigators use two objective measures of bacterial vaginosis
(OSOM BV blue and gram stain) and subjective questionnaires regarding the presence and effect
of vaginal symptoms on the pessary user prior to pessary fitting and at 3 months post pessary
fitting. The investigators hypothesize that Trimo-San gel with not significantly affect the
rate of bacterial vaginosis in pessary wearers as measures by OSOM BV blue and Gram stain,
but will have a positive effect on the subjective symptoms experienced by women wearing
pessaries.