PTNS Versus Sham Efficacy in Treatment of BPS

This is a pilot study to evaluate the efficacy of the systematic effects of posterior tibial
nerve stimulation (PTNS) treatment compared to an inactive sham intervention in female
subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) in an intent-to-treat
analysis. The primary outcome measure will be the Patient Global Impression of Improvement
(PGI-I) a single item questionnaire assessing overall impression of improvement over time at
the initial 12 weeks endpoint.

It is hypothesized that subjects randomized to the PTNS arm will demonstrate a greater
improvement in both pain and quality of life scores, when compared with subjects who are
randomized to the sham arm.

Inclusion Criteria:

- Women ≥18 years old with visual analog scale > 5

- Cessation of all analgesics or other medication for pain for at least 2 weeks prior to
the PTNS intervention

- Discontinuation of any other electrical stimulation methods for 3 months prior to PTNS
intervention.

- Capable of giving informed consent

- Ambulatory

- Capable and willing to follow all study-relation procedures

Exclusion Criteria:

- Patients pregnant or planning to become pregnant during the study duration

- Botox use in pelvic floor muscles within the last year

- Current urinary or vaginal infections

- Current use of Interstim device

- History of a cardiac pacemaker

- Diagnosis of neuropathy