This multicenter, single arm, prospective study evaluated change in quality of life (QoL) after 12 weeks of percutaneous tibial neuromodulation (PTNM) sessions in drug-naïve subjects with overactive bladder syndrome (OAB).

Eligible subjects underwent 12 weekly PTNM sessions, utilizing the NURO™ system. Change in QoL was assessed utilizing the Overactive Bladder Symptom Quality of Life Questionnaire (OAB-q), which measures health-related QoL and subscales of Concern, Coping, Sleep, Social.  Analyses were conducted for subjects with data at baseline and follow-up visits (PTNM sessions #1, #4, #8, and #12).  Safety was evaluated by the collection of adverse events related to the device, procedure and therapy (device-related). Study approval was given by institutional review boards and all subjects provided informed consent.

One hundred and fifty-four (154) subjects enrolled in the study, of which 120 met study criteria and received PTNM.  Subjects had a mean age of 64.8 years with a mean OAB diagnosis of 3.4 years at enrollment, with no subjects having tried an OAB medication prior to enrollment.  Eighty-six percent of subjects were female.  Health-related QoL and its subscales (Concern, Coping, Sleep, Social), as well as symptom bother showed significant improvements from baseline (all p<0.0001) at PTNM sessions #1, #4, #8, and #12 (Figures 1 and 2). Average improvements from baseline for Concern, Coping, Sleep, and health-related QoL were 3 to 4 times greater than the Minimally Important Difference (MID)1 at PTNM session #12. Visit compliance and questionnaire completion was ≥ 96% at each of the four visits where outcomes were assessed. There was an average of 11.6 PTNM sessions per subject.  Additionally, at baseline, subjects had 3.5±2.5 UUI episodes/day; urinary frequency (UF) subjects (≥ 8 voids/day) had 11.5±2.9 voids/day.  After PTNM session #12, a statistically significant reduction of 2.4+2.1 UUI episodes/day was observed (p<0.0001); a statistically significant reduction of 1.7±2.5 voids/day was observed (p<0.0001) for UF subjects. There were no serious adverse device effects or unanticipated adverse device effects. The most common adverse events reported were medical device site pain (3.3%, 4/121) and pain in extremity (3.3%, 4/121).

Clinically and statistically significant improvements in QoL were demonstrated in subjects with OAB through PTNM session #12.

Percutaneous tibial neuromodulation using the NURO system improves quality of life for drug-naïve patients with OAB.

Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. Determining the importance of change in the overactive bladder questionnaire.  J Urol. 2006 Aug; 176(2): 627-32.