THE EFFECTIVENESS OF TRANSCUTANEOUS ELECTRICAL STIMULATION OF THE TIBIAL NERVE IN WOMEN WITH URGE URINARY INCONTINENCE – SHAM CONTROLLED TRIAL

K. Stanonik^1,2, D. Šćepanović³, D. Rugelj¹, M. Rostohar³

¹University of Ljubljana, Faculty of Health Sciences, Ljubljana, Slovenia, ²University Rehabilitation Institute Republic of Slovenia Soča, Ljubljana, Slovenia, ³University Medical Centre Ljubljana, Department of Gynaecology and Obstetrics, Ljubljana, Slovenia

Background: Urge urinary incontinence (UUI) is the most bothersome symptom of the Overactive Bladder Syndrome. It affects 1 – 7 % of the population and it places a significant burden on well-being for those affected. First line treatment for UUI (lifestyle management, urinary bladder training, pelvic floor muscle training) often fails to completely alleviate the symptoms. Further treatments (medication use, botulin toxin A application, sacral neuromodulation, percutaneous tibial nerve stimulation) can pose a significant risk for side effects. Consequently, novel therapeutic options for people with UUI are actively sought. Transcutaneous tibial nerve stimulation (TTNS) has been proposed as a non-invasive alternative to percutaneous tibial nerve stimulation. As such, it is considered a form of peripheral neural modulation that aims at indirect inhibition of unwanted contraction of the urinary bladder. Despite some evidence of TTNS effectiveness, there is a lack of studies comparing active TTNS with sham stimulation.

Purpose: To compare effectiveness of active TTNS with sham TTNS in women with UUI on subjective assessment of improvement.

Methods: 31 adult women were included in this randomised single-blind sham-controlled trial. All included women were referred to the outpatient physiotherapy service with a diagnosis of UUI and have been resistant to previous treatment for UUI. The stimulation protocol consisted of six TTNS with stimulation intensity above motor threshold or six sham 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 stimulation protocol. On the baseline, we found no statistically significant differences between the groups. After the stimulation 3 out of 16 women in the TTNS group and 1 out of 11 women in the sham TTNS group considered that their symptoms, measured with the Global Impression of Improvement Questionnaire, improved much or very much (p=0,624). No woman reported that her symptoms worsened after either TTNS or sham stimulation. Data obtained from three-day Bladder Diary indicated no statistically significant difference between the groups in changes of urinary incontinence episodes (z=1,178; p=0,267), urinary frequency (t=0,422; p=0,678) and night urination (t=0,169; p=0,868). We found no statistically significant difference between changes of the outcomes on the International Consultation on Incontinence Questionnaire – Short Form (t=0,647; p=0,524).

Conclusions: A protocol that consisted of six TTNS does not result in a statistically significant improvement of symptoms in women diagnosed with UUI that have been resistant to previous treatment. Key limitations of our trial are: a small sample size, lack of therapists blinding and a lack of follow-up. Further high-quality randomised controlled trials are required to confirm if TTNS can be used effectively in women with UUI.

Implications: Protocol of six TTNS results in neither clinically nor statistically important improvement of symptoms in women with UUI.

Funding acknowledgements: none

Keywords:
women’s health
urge urinary incontinence
tibial nerve

Topics:
Pelvic, sexual and reproductive health

Did this work require ethics approval? Yes

Institution: Ministry of Health of the Republic of Slovenia

Committee: Medical Ethics Committee of the Republic of Slovenia

Ethics number: 0120-301/2018/6