Prospective Data Bank Creation to Study Vaginal Conditions

Our approach specifically targets the evaluation of the proteins and cytokines present and
the bacteriological analysis of the microflora in the vaginal milieu.

Conjectures:

- An initial insult in the vagina (possibly involving a bacterial, viral or fungal
organism or their products) causes modifications in the vaginal milieu

- The vaginal milieu responds to the insult by developing an inflammatory reaction
characterized by cytokine and protein production

- Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu
producing a reaction, chemical irritation or micro flora alteration by changes in
proteins and/or abnormal protein production

- Those changes eventually result in hypersensitivity, irritation, burning, and pain
manifested in patients with vulvodynia. And those changes may also result in the
recurrence of fungal or bacterial infections

- Those changes may also contribute to initiate the cascade of premature events conducting
to cervical effacement and dilation observed in preterm labor

The conjectures will be investigated by using a multidisciplinary approach including:
microbiology, proteomics and cytokines evaluation of the vaginal milieu. Specifically we will
be comparing an asymptomatic female population to serve as a baseline to patients affected by
vulvodynia, recurrent fungal or bacterial vaginosis and/or pregnancy.

This is a prospective, descriptive study of about 550 women age 12 to 75 years. There will be
four groups: 1) Asymptomatic healthy women, 2) Women being seen for any gynecological
vulvovaginal condition, and 3) Pregnant women who are asymptomatic and healthy, and 4)
Pregnant women have any gynecological vulvovaginal condition.

We will evaluate the following:

- Types of cytokines normally present in women and in patients with vulvodynia, recurrent
fungal and bacterial vaginosis and preterm labor

- Normal microbiology flora in women and variations present in the vaginal milieu in these
patients

- The presence of normal and atypical proteins in the vaginal milieu of healthy women and
patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor

- Informed consent will be obtained and documented for participation in the study

- Comprehensive history assessment of environmental factors, topical vulvovaginal issues
and co morbid conditions as defined in the exclusion criteria.

- Pelvic examination to obtain two samples via cotton swabs for proteomics, cytokines,
vaginal lactobacillus from vaginal secretions.

A. Swab procedure:

The cotton swabs (2) will be introduced only in the middle vagina, one at the time, no other
areas will be sampled.

B. Swab processing One swab will be placed in a special room temperature solution. This
de-identified swab will be mailed for Lactobacillus.

The second de-identified swab is to be place in 2 separated micro-containers in Liquid
Nitrogen Containers (one for cytokines and one for Proteomics). When 50 samples are completed
they will be processed at TTUHSC Permian Basin campus, with the Proteomics testing being done
in Lubbock.

Therefore, there are 3 samples, each processed differently. Data will be recorded in a
confidential manner with no personal identifiers, only an assigned study subject number. As
such, the de-identified data may serve as a database for additional studies. The computer
used will belong to TTUHSC and be password protected, access limited to only authorized
personnel. Consent forms will be stored separately from the study data in the research
office.

Inclusion Criteria:

- All patients willing to participate, and give informed consent, and

- Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history
of any chronic or recurrent vulvovaginal condition who attend our clinical offices for
their annual well-woman physical examination.

- Non-pregnant women ages 21 to 75 years being evaluated for any gynecological
vulvovaginal condition.

- Pregnant women ages 21 to 75 years who are both asymptomatic and healthy

- Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition

Exclusion Criteria:

- Asymptomatic patients ages < 21 or > 75, or symptomatic patients ages < 21 or > 75
years.

- Patients diagnosed with cancer or having any medical condition that is not under
control including: diabetes mellitus, hypertension, collagen disease,
hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic
attacks

- Patients unable to follow the protocol or unwilling to participate