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Efficacy of Neuromodulation for Refractory Interstitial Cystitis/Painful Bladder Syndrome
Sara M. Lenherr, M.D., Gjanje L. Smith, MD, John F. Bresette, MD, John T. Stoffel, MD.
Lahey Clinic Medical Center, Burlington, MA, USA.

BACKGROUND: Our objective was to evaluate the efficacy of sacral neuromodulation for treating refractory interstitial cystitis/painful bladder syndrome (IC/PBS) symptoms.
METHODS: IC/PBS patients treated with sacral neuromodulation (Medtronic) were retrospectively identified. All patients met ICS definition for IC/PBS and had refractory urinary symptoms for at least 6 months after pharmacologic and endoscopic therapy. Patients with a 50% improvement in voiding symptoms during a 2 week percutaneous testing period progressed to an implantable pulse generator (IPG). Outcomes were assessed by comparing O’Leary-Sant IC Symptom (4 questions, maximum 25 points) and Problem (4 question, maximum 20 points) scores at baseline prior to percutaneous neuromodulation testing, <3 months, 3-12 months and 12 months after IPG implantation. Patients who had turned the IPG off, had the leads and/or IPG removed or did not return for follow up were considered to have failed therapy.
RESULTS: 24 refractory IC/PBS patients (22 females) underwent percutaneous sacral neuromodulation testing. Mean patient age was 45.1 years (range 22-73). Twenty-two patients (92%) progressed to IPG implantation. At 3 months follow-up, 17 devices (77%) were still in place (4 patients lost immediately to follow-up and 1 IPG removed). At 3-12 months, 15 devices (68%) were still in use (2 removed). At one year follow-up, 12 devices (55%) were still in place (1 device removed, 2 lost to follow-up). Observed reasons for discontinuing neuromodulation included pain or infection at IPG site (n=2) or need for an MRI (n=1) and unknown reasons (n=1). Available mean baseline IC Symptom and Problem scores (n = 19) were 15.2 (SD 4) and 14.1 (SD 2.8), respectively. Not all patients had Questionnaire scores available at every time point, but of those still using neuromodulation at the <3 months, symptom and problem scores decreased significantly from baseline by 8.3 points each (mean score 6.2 and 5.7, respectively). At the 3-12 month time point, symptom scores were not notably improved from baseline (mean score 10.4) but the problem scores remained significantly improved (mean score 7.7). At the 12 month time point (n =11), symptom scores and problem scores were both significantly improved from baseline (mean scores 7.4 and 5.6, respectively). Complications included wound infection (n = 5), IPG site pain (n=3), and IPG failure (n = 3).
CONCLUSIONS: In our study, sacral neuromodulation had a steady discontinuation rate during the first year of treatment for IC/PBS. For patients that used neuromodulation for one year, symptom scores returned to near pre-operative baseline after 3 - 12 months of treatment, but improved again with follow-up greater than 12 months. Problem scores remained significantly improved over baseline after 12 months of treatment. These findings need to be validated in a large multi-institutional study.


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