The Effects of Sacral Neuromodulation for Urinary Urgency, Frequency, and Urge Incontinence

Urinary urgency, frequency, and urge incontinence are very common symptoms, affecting up to
one in three adults in the United States. The total economic cost of these disorders was
estimated to be above $12 billion in the year 2000, with the vast majority being for women.

Sacral neuromodulation (SNM) has become a popular and successful treatment option for people
who suffer from these conditions. Sacral neuromodulation device delivers electrical pulses to
an area near the sacral nerve.

There has been some data published which showed that for patients with fecal incontinence,
symptom relief can persist for significant time periods despite having the stimulator device
turned off. Based on their findings, potential exists to prolong battery life if patients can
cycle the on and off periods for their device while keeping their symptoms stable.

The typical battery life of the implantable pulse generator (IPG) is approximately 5 years
depending on the system settings. When the IPG is at the end of its battery life, a new IPG
must be implanted. The cost of replacing the IPG ranges from $13,952 to $16,470. IPG
replacement must be done in the operating room and requires the patient to undergo anesthesia
and its associated risks.

This study will investigate whether the symptoms of urinary urgency, frequency, and urge
incontinence remain stable in patients with SNM with the device turned off for a period of
four weeks.

Current Cincinnati Urogynecology Associates (CUA) patients who are currently being
successfully treated with sacral neuromodulation for the primary diagnosis of urinary urge
incontinence or urgency and frequency who elect participate in the study will have the device
turned off for four consecutive weeks. Their symptoms will be monitored during this time
period.

Inclusion Criteria:

- Women, aged 18-85 with who have previously had the InterStim device implanted and have
experienced good control of their symptoms for at least one year.

Exclusion Criteria:

- Patients with less than 6 months of expected battery life on their device established
at office testing.

- Patients with poor control of their symptoms within the last one year.

- Patients with degenerative neurological disorders or spinal cord injuries.

- Patients with cognitive disabilities or those lacking the mental capacity to
understand and answer questionnaires.

- Patients who are pregnant or may become pregnant.