Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome

Study Overview
=================
Brief Summary
-----------------
INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society as urgency, with or without incontinence, usually with increased urinary frequency and nocturia. It is difficult to estimate the prevalence of this syndrome because many patients do not seek medical help, despite considerable negative impact on quality of life. Lower urinary tract dysfunctions can be treated using electrical stimulation of the posterior tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary frequency and nocturia . Due to lack of consensus on the parameters of this technique, further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will accept up to 145 women with overactive bladder diagnosis for at least six months prior to the beginning of the study. The subjects will be divided into five groups: group TENS 0-1 (placebo group), group TENS 1-1 (electrical stimulation of one leg once a week), group TENS 1-2 (electrical stimulation of one leg twice a week), group TENS 2-1 (electrical stimulation of two legs one a week) and group TENS 2-2 (electrical stimulation of two legs twice a week). Physical evaluation will be done at the beginning and at the end of the treatment. Evaluation will be done using the King s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for follow-up treatment.

Detailed Description
-----------------
Participants will be recruited from Urogynecology Physical Therapy Outpatient Clinic of a university hospital and randomly assigned using website www.randomization.com and distributed into five groups considering the sites of application and frequency of attendanc, listed above. Data will be collected by the investigator using interview and physical examination and will be safely stored in computer. For this study, in terms of urinary frequency, the standard deviation was estimated at 3.25 episodes of urinary urgency (SD=3.25). With 80% power and 95% confidence, the sample size calculation was 25 women in each group, plus a possible sample loss of around 20%, resulting in a sample size of 29 women per group, for a total of 145 patients in the study. The chi-square test was used to assess whether there was an association between sample description variables and treatments. The analysis of variance F-test was used to assess whether there were differences in the numerical descriptive variables between treatment groups. The nonparametric Kruskal-Wallis test was used to compare treatments in terms of the difference between before and after for each quality of life and voiding diary variables. If there was statistical significance, the Dunn multiple comparison test was performed, with p-values of less than 0.05 considered significant. The analysis of variance model with repeated measures was used to compare data from the specific voiding diary according to the treatment groups and sessions. Significant comparisons were evaluated with Tukey post-hoc test. To approximate data to the normality, a 1/log (variable+1) transformation was done. For the follow up analysis, it was used the ANOVA three ways, with Holm Sidak post-hoc test for comparison of scores. All the statistical tests developed were based on a significance of 5%, i.e., the null hypothesis was rejected when the p-value was less than 0.05.

Official Title
-----------------
Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome: Randomized Blind Clinical Trial

Conditions
-----------------
Overactive Bladder Syndrome

Intervention / Treatment
-----------------
* Device: TENS 1-1
* Device: TENS 1-2
* Device: TENS 2-1
* Device: TENS 2-2
* Device: TENS 0-1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with 18 years of age or more; Cognitive level adequate for understanding orientations during treatment; Clinical diagnosis of overactive bladder syndrome for at least six months prior to the study. Exclusion Criteria: Pregnant women or women who wish to get pregnant; Neurological disease; Urinary infection; Nephrolithiasis; Stress urinary incontinence; Mixed urinary incontinence; Women in pharmacological treatment for overactive bladder syndrome; Women undergoing hormone replacement therapy in the last six months; Peripheral neuropathy; Cystocele stage two or higher.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group TENS 0-1<br>Electrodes will be fixated to one leg and sessions will be held once a week. | Device: TENS 0-1<br>* Placebo: application os electrodes of Transcutaneous Electrical Nerve Stimulation on one leg once a week, without turning on the device.<br>|
| Experimental: Group TENS 1-1<br>Electrical stimulation of the posterior tibial nerve of one leg once a week. | Device: TENS 1-1<br>* Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg once a week.<br>|
| Experimental: Group TENS 1-2<br>Electrical stimulation of the posterior tibial nerve of one leg twice a week. | Device: TENS 1-2<br>* Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg twice a week.<br>|
| Experimental: Group TENS 2-1<br>Electrical stimulation of the posterior tibial nerve of two legs once a week. | Device: TENS 2-1<br>* Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs once a week.<br>|
| Experimental: Group TENS 2-2<br>Electrical stimulation of the posterior tibial nerve of two legs twice a week. | Device: TENS 2-2<br>* Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs twice a week.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary frequence in 12 sessions. | Number of micturitions per day. | The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nocturia in 12 sessions. | Number of micturitions per night, interrupting sleep. | The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session. | 
| Change in urinary urgence in 12 sessions. | Number of urgent micturitions per day. | The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session. | 
| Change in urinary urge-incontinence in 12 sessions. | Number of leaks per day. | The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session. |