Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of Interstitial Cystitis/Painful Bladder Syndrome

The overall objective of this prospective, pilot study is to determine if percutaneous tibial nerve stimulation (PTNS) is an effective treatment for interstitial cystitis/painful bladder syndrome (IC/PBS). Our specific aim is to evaluate how PTNS performs with regards to the reduction of symptoms in subjects with this disorder. The primary outcome variable will be the percentage of subjects to report that they are moderately improved or markedly improved in overall symptoms compared to baseline on a 7-point global response assessment (GRA) scale. The GRA scale involves asking the question, "As compared to when you started the current study, how would you rate your overall symptoms now?". There are 7 possible responses: markedly worse, moderately worse, slightly worse, the same, slightly improved, moderately improved and markedly improved. This scale is the current standard for outcome in studies that are evaluating treatments and interventions for IC/PBS.

There will be a number of secondary outcome variables including: changes in a 24 hour voiding diary during the course of the interventions, ratings for bladder pain, urinary urgency and urinary frequency on standardized scales, the score on O'Leary-Sant IC Symptom and Problem Index, scores of validated questionnaires for pelvic floor and general health. The investigators will also collect and report any adverse events.

Subjects will be recruited during a routine visit to the University of California, Irvine (UCI) urogynecology division that the patient has scheduled to initiate or continue routine care for their complaints. If the provider feels that the patient may be appropriate for the study and meets the inclusion/exclusion criteria, she will offer to have a study investigator speak with patient at that time or at a later time at the patient's convenience. Once consents are signed, the subject will be provided with the following materials to complete before their first treatment visit:

1. demographic and medical history survey
2. 24 hour voiding diary
3. visual analog scale (VAS) for bladder pain
4. Pelvic Pain and Urgency/Frequency Patient Symptom Scale (PUF Questionnaire)
5. O'Leary-Sant IC Symptom and Problem Index
6. urine pregnancy test (for premenopausal subjects)

The PTNS treatment visits will be administered in the standard fashion. This involves the placement of a thin needle (similar to an acupuncture needle) inserted near the posterior ankle. The needle is then connected to an electrode stimulator and the stimulation is adjusted until appropriate response (toe flex or fan) is obtained without patient discomfort. When at the appropriate level, the electrode is stimulated for 30 minutes per treatment session.