This is a report of a prospective, international multicenter 12 week trial of the novel implantable eCoin™ system for tibial nerve stimulation (TNS) that evaluated changes from baseline in overactive bladder syndrome (OAB) symptoms on voiding diaries and patient reported outcomes after 12 weeks of treatment at 7 centers.

46 subjects were implanted with the eCoin™ device over the posterior tibial nerve at baseline (Figure) and then automatically treated for 30 minute sessions.  Subjects completed 3-day bladder diaries to assess change in voiding symptoms at 4, 8 & 12 weeks from baseline. Subjects also completed the Incontinence Quality of Life (iQOL) and Patient Global Impression of Improvement (PGI-I) questionnaires.  Safety was evaluated by reported adverse events. The eCoin™ system was implanted subcutaneously posterosuperior to the medial malleolus over the tibial nerve under local anesthesia in the office.

Three of the 46 subjects were excluded, one who did not receive therapy and two because of incomplete baseline data.  .The mean age of the 43 women implanted was 62.5± 11.3 years.  After 12 weeks of treatment there was a 63% reduction in urgency urinary incontinence episodes (UUI) with a decrease from 5.24 ± 2.93 to 1.95 episodes/day at 3 months. The mean iQOL score at baseline was 45.9±20.8 and improved to 26.5±21.2 after 3 months of treatment (p=0.0004).  The iQol has a minimally important difference (MID) of 10 points.  Seventy-two percent of subjects (31/43) met this threshold and had a ≥10 point change in their iQOL scores after 12 weeks of treatment.   After 12 weeks, 31 of 43 subjects (72%) said they were better, much better, or very much better on the PGI-I. Thirteen subjects reported feeling “better” (30%), 3 reported feeling “much better” (7%) and 15 reported feeling “very much better” (35%) on the PGI-I.  
Serious adverse events were noted in 3 subjects. Cellulitis secondary to an ankle wrap occurred in one subject, one subject who had edema at baseline developed a limp with leg edema from pre-existing hip bursitis and one had an unrelated pneumonia.

These data from this feasibility trial show that there was a significant improvement in urinary continence associated with a clinically meaningful improvement in quality of life.

These data, showing a significant improvement in quality of life and UUI suggest great promise for eCoin™ stimulation of the tibial nerve to treat OAB without the need for weekly office visits.