Pilot Study of Percutaneous Posterior Tibial Nerve Stimulation for the Treatment of IC/PBS
Interstitial Cystitis, Painful Bladder Syndrome
About this trial
This is an interventional treatment trial for Interstitial Cystitis focused on measuring Posterior tibial nerve stimulation, PTNS, IC
Eligibility Criteria
Inclusion Criteria:
- clinical diagnosis of IC/PBS
- complaint of urinary urgency (sudden, compelling desire to pass urine which is difficult to defer) or urinary frequency (voiding >8 times per 24 hour period)
- female
- have undergone at least 1 course of a standard therapy for IC/PBS
- 18 years of age or older
Exclusion Criteria:
- not having undergone at least 1 course of a standard therapy for IC/PBS
- having a pacemaker or implantable defibrillator
- being prone to excessive bleeding
- having nerve damage that could impact the posterior tibial nerve
- pregnant or planning pregnancy during treatment course
- non-English speaking
- current malignancy
Sites / Locations
- University of California-Irvine Medical Center
Arms of the Study
Arm 1
Experimental
Posterior Tibial Nerve Stimulation
PTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots. If benefits are obtained, 12 weeks of treatment is followed by spaced maintenance sessions at timing of provider and patient discretion.