INTRODUCTION: We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients. METHODS: We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant. RESULTS: We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups. CONCLUSIONS:TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.
RCT Entities:
INTRODUCTION: We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients. METHODS: We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant. RESULTS: We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups. CONCLUSIONS: TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.
Authors: Charles H Knowles; Emma J Horrocks; Stephen A Bremner; Natasha Stevens; Christine Norton; P Ronan O'Connell; Sandra Eldridge Journal: Lancet Date: 2015-08-18 Impact factor: 79.321
Authors: A Groutz; J G Blaivas; D C Chaikin; N M Resnick; K Engleman; D Anzalone; B Bryzinski; A J Wein Journal: J Urol Date: 2000-09 Impact factor: 7.450
Authors: Anthony G Visco; Linda Brubaker; Holly E Richter; Ingrid Nygaard; Marie Fidela R Paraiso; Shawn A Menefee; Joseph Schaffer; Jerry Lowder; Salil Khandwala; Larry Sirls; Cathie Spino; Tracy L Nolen; Dennis Wallace; Susan F Meikle Journal: N Engl J Med Date: 2012-10-04 Impact factor: 91.245
Authors: Bernard T Haylen; Dirk de Ridder; Robert M Freeman; Steven E Swift; Bary Berghmans; Joseph Lee; Ash Monga; Eckhard Petri; Diaa E Rizk; Peter K Sand; Gabriel N Schaer Journal: Neurourol Urodyn Date: 2010 Impact factor: 2.696
Authors: W F Stewart; J B Van Rooyen; G W Cundiff; P Abrams; A R Herzog; R Corey; T L Hunt; A J Wein Journal: World J Urol Date: 2002-11-15 Impact factor: 4.226