Hypothesis / aims of study
Percutaneous Tibial Nerve Stimulation or Percutaneous Tibial Neuromodulation (PTNM) is a therapy for Overactive Bladder (OAB) delivered over 12 consecutive weekly sessions. However, little is known about the application and adherence of this treatment in a real-world setting. This analysis aims to summarize patients’ time to complete treatment course and examine trends of two third-line therapy use--Sacral Neuromodulation (SNM) and onabotulinumtoxinA --during and after the treatment course.
Study design, materials and methods
Optum’s de-identified Clinformatics® Data Mart (CDM) Database and CMS Research Identifiable File (RIF) healthcare claims were queried for adults diagnosed with urgency, frequency and urge incontinence and underwent PTNM treatment during 2019—allowing for a 1-year follow-up period. Patients were required to have continuous enrollment and pharmacy coverage from 1-year prior to the initial PTNM treatment through the follow-up period. PTNM treatment within 30 days of a previous treatment was defined as part of the initial therapy. Compliance was defined as 12 PTNM-related visits. Primary outcomes were percentage of compliant PTNM-related visits within 1 year and total number of patients with SNM and onabotulinumtoxinA within the same year, segmented by 12-, 15-, 22-, and 52-week periods.
Results
A total of 3,087 patients were included from CDM and 9,727 patients from RIF data. Completion of the initial treatment (12 treatments) increased over time from 16% at week 12 to 42% by week 52 and 24% to 38% for CDM and RIF data, respectively (Fig 1; both p<0.001). Similarly, utilization of third-line therapy increased over time and was higher for non-compliant patients: 0.2% of compliant and 0.8% of non-compliant CDM patients used onabotulinumtoxinA within 12 weeks (p=0.074). 0.6% of non-compliant RIF patients used onabotulinumtoxinA within 12 weeks while the volume of compliant RIF patients is too low to report. However, 4.9% of CDM compliant patients and 6.4% non-compliant used onabotulinumtoxinA within 52 weeks from the initial PTNM treatment; (p=0.035). 6.5% of non-compliant RIF patients and 5.7% of compliant patients used onabotulinumtoxinA within 52 weeks; (p=0.066). Similarly, SNM implant rates within 12 weeks were <1% for CDM and RIF patients. Within 52 weeks, SNM implant rates for CDM patients were 1.2% for compliant patients and 2.6% for non-compliant patients; (p= 0.002) and for RIF patients, 1.7% for compliant patients and 2.4% for non-compliant patients; (p=0.010).
Interpretation of results
Most patients are not compliant with the recommended treatment regimen of 12 PTNM treatments in 12 weeks. Patients non-compliant with the PTNM treatment regimen were more likely to pursue third-line treatment options.