To compare the efficacy of PTNS in the subset of OAB subjects experiencing FI symptoms from two trials.
Two multi-center clinical trials, OrBIT and SUmiT, were completed. The OrBIT Trial was an open-label trial of which 10% (5/50) experienced FI. The SUmiT Trial was a double-blind trial of which 13.6% (15/110) experienced FI. In each study, subjects received 12 weekly 30-minute PTNS treatments in which stimulation was delivered through a 34-gauge needle electrode inserted near the posterior tibial nerve using the Urgent PC device. At the end of 12 weeks, questionnaires and voiding diaries were completed.
Baseline characteristics were similar across both groups in this subset cohort. In the OrBIT Trial, mean age was 61 years with 3 subjects less than age 65. Similarly, the mean age in the SUmiT Trial was 68 years with 3 subjects less than age 65. In the OrBIT Trial, the subject-completed Global Response Assessment (GRA) for FI symptoms indicated 80% (4/5) had reported improvement after 12 PTNS treatments. In the SUmiT Trial, after 12 PTNS treatments, 82% (9/11) reported improvement in FI symptoms, 4 subjects were excluded due to a “not applicable” response on their questionnaire. The combined GRA data reports 81% (13/16) had improvement in FI symptoms after 12 weekly PTNS treatments.
Although the two studies were designed for OAB, GRA outcomes suggest PTNS provides symptom relief for patients experiencing FI after receiving 12 weekly treatments. Further research in larger study populations is needed.
Source: Original Presentation