Trial of Trimosan Gel Effect on Pessary-associated Bacterial Vaginosis

The study population will consist of women who will be fitted for and initiate use of a
pessary for relief of pelvic organ prolapse and/or urinary symptoms.

All patients scheduled for pessary fitting/initiation who meet the above inclusion criteria
will be asked to participate in the study. They are randomized using opaque envelopes pulled
sequentially, which were made originally from a blocked design, stratified to women removing
the pessary daily themselves and women not removing the pessary daily themselves. Prior to
pessary fitting all women in the study answer a brief questionnaire about their vaginal
symptoms. Subjects undergo a vaginal swab for OSOM BV Blue (copyright by Genzyme, SekiSui)
and Gram stain testing for Nugent's criteria the presence of bacterial vaginosis. Women are
then fitted with and instructed on use of a pessary in the standard fashion by a trained
physician at at the study sites.

Women will be randomized to either standard pessary care or to use of TrimoSan gel twice a
week (half applicator) to the vagina either with applicator or applying half applicator
amount to the surface of the pessary before insertion. If women are using additional vaginal
medications such as Premarin this information will be collected but not change their
randomization and they will continue to use other indicated vaginal medications as they did
before participation in the study (per clinical judgement).

At 2 weeks and 3 month after pessary initiation the patients are seen for an office visit.
At both the 2 week and 3 month visit they have repeat testing for bacterial vaginosis using
vaginal swab for OSOM BV Blue (copyright by Genzyme) and Gram stain testing. At both the 2
week and 3 month visits they will also answer a questionnaire about their vaginal symptoms
and the effect of these symptoms on their distress and lifestyle. This questionnaire is
similar to the baseline questionnaire answered before initiation of pessary use, and will
include questions about whether these symptoms have changed since initiation of their
pessary. At the University of New Mexico site, information is also being collected on sexual
function using the PISQ-IR questionnaire and on body image using the modified Body Image
Scale at baseline, 2 weeks, and 3 months. At this particular site women will also answer
questions about their management of the pessary (e.g. if they take it out for intercourse)
surrounding sexual activity.

The recruitment goal for this study is 150 women, with 75 in each group. This was calculated
to detect a significant difference in the rate of bacterial vaginosis between the control
and study groups (α=0.05), and assuming baseline of bacterial vaginosis to be approximately
10% in the population and increased to 30% by hypothetical risk factors, the sample size
needed for each group is 62 for a power of 80%. Assuming a 15% dropout rate after
recruitment, we plan to randomize at least 75 patients to the control group and 75 patients
to the study group for a total of at least 150 patients. 60 women were recruited for this
study at the initial site of Washington Hospital Center in Washington, D.C. This study site
closed in June 2012. In January 2013 the study opened at University of New Mexico in
Albuquerque, NM. The study is currently opening and running at University of New Mexico with
the recruitment goal of 90 women at this institution.

The primary outcome measure will be rate of bacterial vaginosis in the study population, to
be compared between the control (non Trimo-San using) and study (Trimo-San using) groups. As
part of this analysis, we will also compare the rate of bacterial vaginosis in the control
and study groups before and after pessary initiation. Secondary outcomes will include:

- Change in vaginal symptoms as assessed by questionnaire before and after initiation of
pessary use

- Change in level of worry or distress about vaginal symptoms as assessed by
questionnaire before and after initiation of pessary use.

- Change in vaginal symptoms or distress about these symptoms as assessed by
questionnaire based on use or non-use of Trimo-San gel.

- Describe the management of women of their pessary surrounding sexual activity
(University of New Mexico only)

- Change in body image or sexual function associated with initiation of the pessary or
use of TrimoSan gel (University of New Mexico only)

Inclusion Criteria:

- Female

- Indications for initiation of pessary use and planning to be fitted for and wear a
pessary

Exclusion Criteria:

- Male

- Already using a pessary or have used in the last year

- History of recurrent or chronic bacterial vaginosis with > 2 episodes per year or
symptoms reported for > 6 months out of last year

- Active known vaginal infection (symptomatic and/or untreated) or completion of
treatment for BV or cervical/vaginal infection within one week of recruitment

- History of active vaginal ulcerative disease (active ulcers from atrophy, herpes
symptoms at recruitment, or HSV with > 2 outbreaks per year or last outbreak < 1
month ago)

- Chronic antibiotic use for indications not listed above