Introduction: Urge urinary incontinence (UUI) is the most bothersome symptom of the Overactive Bladder Syndrome. Transcutaneous tibial nerve stimulation (TTNS) is a form of peripheral neural modulation that aims at indirect inhibition of unwanted contraction of the urinary bladder. Despite some evidence of TTNS efficacy, there is a lack of studies comparing active TTNS with sham stimulation. Purpose: The purpose of this master thesis is to compare efficacy of active TTNS with stimulation intensity above motor threshold with sham TTNS on subjective assessment of improvement. Methods: We included 31 women, diagnosed UUI that have been resistant to previous treatment, in this randomized, placebo controlled trial. The stimulation protocol consisted of six TTNS with stimulation intensity above motor threshold or six placebo TTNS. The primary outcome of the trial was improvement on the Global Impression of Improvement questionnaire. The secondary outcome was improvement on three-day bladder diary and International Consultation on Incontinence Questionnaire – Short Form. Results: Twenty-seven (87 %) women successfully completed the electric stimulation protocol. Three out of 16 women in the TTNS group and one out of 11 women in the placebo TTNS group reported that their symptoms have improved much or very much. We found no statistically significant difference between the groups regarding the symptom improvement (p = 0,624). No woman reported that her condition worsened after either TTNS or placebo stimulation. We found no statistically significant changes in secondary outcomes after the stimulation in either of the two groups. Discussion and conclusion: A protocol that consists of six TTNS does not result in statistically significant improvement of symptoms on population of women with UUI that have been resistant to previous treatment. One of the reasons for lack of the effect in our trial can be found in shorter TTNS duration in our trial when compared to other trials. The key limitations of our trial are: a small sample size, lack of therapists or assessors blinding and a lack of follow-up. Future high quality studies are necessary to provide robust evidence on effectiveness of TTNS on population with UUI that have been resistant to previous treatment.
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