Effects of TENS in Autonomous System in Women With Overactive Bladder

Summary

The International Continence Society (ICS) defines overactive bladder ( OAB) as a clinical syndrome characterized by urgency with or without urge incontinence , usually accompanied by frequency and nocturia , since in the absence of proven infection or other pathology related . The negative impact on quality of life of patients with OAB is already known. The etiology and pathophysiology of OAB are not completely understood. However, studies indicate an alteration of sympathetic and parasympathetic nerve stimulation involved in the mechanism of OAB. A Transcutaneous Electrical stimulation of the Tibial Nerve ( TENS) has been studied as a noninvasive and inexpensive , treating the symptoms of this syndrome therapeutic way . However, no studies in the literature evaluating the effect of electroconvulsive therapy on the mechanisms involved in sympathetic and parasympathetic modulation in these women . The objective of this study is to investigate the effects of TENS on the sympathetic and parasympathetic system in women with OAB . This is a randomized, double -blind , which will be assessed , first, in a pilot study , 30 female patients with OAB randomly allocated into 2 groups : TENS group and placebo group. Interventions take place in one day assessment of the sympathetic and parasympathetic nervous system are performed . After collecting the data will be analyzed in accordance with the statistical analysis.

Conditions

• Urinary Bladder, Overactive

Interventions

OTHER

Intervention group

The device current generator TENS used was " Neurodyn Portable Tens / Fes " of IBRAMED brand. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used. Through a chain of 1Hz, the aim is to correctly identify the tibial nerve. This position is confirmed with the rhythmic movement of the finger flexion. The frequency is then changed to 10Hz, the pulse width set at 200 "microseconds" and adjusted according to the intensity threshold for each patient, below motor threshold. This current generator also has a device, the VIF (variation in intensity and frequency) that aims to ease the accommodation of sensory receptors and enhance its effects. The application time is 30 minutes

OTHER

Placebo group

The placebo group received an active current for 15 seconds by means of an apparatus also IBRAMED brand externally similar to that used in GI. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used.The application time for GP also was 30 minutes .

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre

  lead OTHER

Principal Investigators

• Luís T da Rosa, PhD · Federal University of Health Science of Porto Alegre

• Caroline HL de Lima, Msc · Federal University of Health Science of Porto Alegre

• Patrícia V da Rosa, PhD · Federal University of Health Science of Porto Alegre

• Rodrigo DM Plentz, PhD · Federal University of Health Science of Porto Alegre

• Cinara Stein, PhD · Federal University of Health Science of Porto Alegre

• Fabrício E Macagnan, PhD · Federal University of Health Science of Porto Alegre

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

60 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-03-31

Primary Completion

2014-08-31

Countries

• Brazil

Study Locations