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

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.

Conditions

• Overactive Bladder Syndrome

Interventions

DEVICE

TENS 1-1

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg once a week.

DEVICE

TENS 1-2

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg twice a week.

DEVICE

TENS 2-1

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs once a week.

DEVICE

TENS 2-2

Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs twice a week.

DEVICE

TENS 0-1

Placebo: application os electrodes of Transcutaneous Electrical Nerve Stimulation on one leg once a week, without turning on the device.

Sponsors & Collaborators

• University of Sao Paulo General Hospital

  lead OTHER

Principal Investigators

• Elizabeth AG Ferreira, PhD · Faculty of Medicine, University of São Paulo, São Paulo, Brazil

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-10-09

Primary Completion

2014-08-25

Completion

2014-09-25

Countries

• Brazil

Study Locations