Interstitial Cystitis (IC)-Like Findings With Hydrodistension

Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic
procedure involving cystoscopy will be approached to participate in the study. They will be
approached either at the time of an office visit or on the day of the scheduled procedure in
the preoperative area.

Study-Related Once consented, they will be requested to fill out the study questionnaires. IC
Problem Index/IC symptom Index, Pelvic Pain and Urgency/Frequency Patient Symptom Scale(PUF),
IBS (Irritable Bowel Syndrome) questionnaire, Functional Esophageal Disorder Questionnaire,
and Painful Bladder questionnaire. Completion of these questionnaires should take
approximately 15 minutes.

Cystoscopy-Standard of care The bladder will be be emptied prior to cystoscopy. Cystoscopy
will be performed with a 5 mm 30o or 70o cystoscope. The angle of view through the scope (or
what the physician sees) is described as 30 degrees or 70 degrees. Sterile saline or water
will be infused under direct visualization. Fluid bag will be held at 80 cm above the
patient. After 200 cc's of filling the infusion will be stopped. This is the standard
procedure for cystoscopy. A resurvey of the bladder will be performed. A minimum of two
pictures will be taken - one of the back wall and one of the dome of the bladder. Any
abnormal findings will be recorded as well.

Hydrodistension- standard of care or study related. The bladder will be filled by gravity (no
pressure) the fluid bag is held 80-100cm above the bed level and the bladder is filled by
gravity. Fluid will stop when the bladder reaches capacity or the physician will stop the
flow when 700cc is reached. Once the bladder is filled, it is then partially emptied. This
procedure should take no more than 60 seconds. The bladder is left partially filled so the
physician can take a final look (resurvey) at the bladder before the procedure is completed
and the scope withdrawn. This is the standard procedure for hydrodistension. At least five
pictures will be taken: trigon, left and right bladder wall, posterior wall of the bladder,
and dome of the bladder. A short video clip (approximately 10-15 seconds long) will be taken
as well for documentation. Again, any abnormal findings will be documented.

Image review-study related Cystoscopic images will be de-identified and pooled. Batches of 25
sets of images will be evaluated by a panel of urogynecologists. Each reviewer will evaluate
each set of images, ranking them as: positive, equivocal or negative for interstitial
cystitis findings. A minimum of 10 glomerulations per quadrant in 3 out of 4 quadrants, or
any Hunner ulcers will be required for positive diagnosis. Glomerulations will be graded by
distribution and number. Additional findings will be recorded: trabeculations, metaplasia,
masses, stones, etc. In cases of equivocal findings, the panel can review video clip that may
contain additional visual information.

Study related Patients who have positive findings for interstitial cystitis during cystoscopy
with hydrodistension, will be notified of the findings after the procedure. At their 4 week
and 6 month followup visits these patients will be asked to fill out the IC Problem Index/IC
symptom Index questionnaire, this will be compared to the same questionnaire the patient
filled out pre op. If the patient is unable to come to the office they may receive a phone
call to complete the questionnaire or if they have access to e-mail they may be able to
complete the questionnaire on a secure web base site (Red Cap). The follow up questionnaire
will not be completed by those who are not diagnosed with interstitial cystitis and their
participation in this study will end after the procedure, and they will be referred back to
their primary or referring physician for follow up.

Study related The patient's medical record will also be reviewed for history and
demographics.

Standard of care Patients with IC will be treated by their primary providers as clinically
indicated.

Inclusion Criteria:

1. Female

2. Patients must be at least 18 years of age.

3. Patients must have been previously scheduled for a surgical procedure that includes
cystoscopy under anesthesia or cystoscopy with hydrodistension under anesthesia.

4. Patients must be able to provide written informed consent.

Exclusion Criteria:

1. pregnancy

2. planned cystotomy

3. incidental cystotomy during surgery - patient not eligible for hydrodistention

4. patient's age > 90

5. history of pelvic radiation 6, Previous or newly diagnosed bladder tumor