Effects of TENS in Autonomous System in Women With Overactive Bladder

NCT02456441 | Unknown DMC

• 1 other identifier: CAAE 17136213.0.0000.5345
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Parasympathetic and sympathetic system values obtained from heart rate variability (HRV) after TENS application

  For the analysis of HRV time, series of RR intervals obtained from continuous ECG signal recorded (sampling frequency = 1 kHz) for the MP150 system (Biopac, California, USA) will be interpolated and decimated to obtain equally spaced in time series and then subjected to a Fast Fourier Transform (FFT) algorithm developed using a Matlab (Matlab 6.0, Mathworks Inc., USA) language. The spectral power is calculated by integrating each frequency band of interest. The time series of RR will be analyzed in the time domain and the frequency and variability parameters and autonomic balance will be obtained. In the time domain we calculate the mean values of RR intervals, standard deviation and the square root of the sum of the square of successive differences (rMSSD).

  50 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

Will be obtained the evolution parasympathetic and sympathetic system 10 minutes after TENS application, through Heart Hate Variability analysis.

Other: Intervention group

Placebo group

PLACEBO COMPARATOR

Will be obtained the evolution parasympathetic and sympathetic system 10 minutes after placebo current application, through Heart Hate Variability analysis. p. The placebo group will receive transcutaneous electric stimulation, for 30 seconds and then will gradually decrease by 15 seconds to not pass any current. This approach will aim to masking of the subject.

Other: Placebo group

Interventions

Intervention group OTHER

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

Also known as: Transcutaneous electric stimulation

Intervention group

Placebo group OTHER

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 .

Also known as: GP

Placebo group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 40 and 60 years;
• Clinical Diagnosis of Overactive Bladder Syndrome non neurogenic type;
• Score Questionnaire OAB-V8, sum equal to or greater than eight (8);
• Calendar indicating voiding more than 8 micturitions in 24 hours;
• Complaints of urinary urgency.

You may not qualify if:

• With a diagnosis of lower urinary tract;
• Signs of leukorrhea / diagnosis of vaginitis;
• Pregnant women;
• Diagnosed with bladder cancer and other pelvic organs;
• With a history of pelvic radiotherapy;
• With change in the sensitivity of the pelvis and lower limbs region;
• With Diabetes Mellitus;
• With known neurologic diseases;
• Patients on medications that may affect the autonomic nervous system, including anticholinergics, alpha-adrenergic antagonists, tricyclic antidepressants, serotonin, antimuscarinic, beta-receptor agonists or antagonists and antihypertensive agents;
• Use of cardiac pacemakers.

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (1)

Caroline Helena Lazzarotto de Lima

Frederico Westphalen, Rio Grande do Sul, 98400000, Brazil

Location

Related Publications (7)

• Rosier PF, Hosker GL, Szabo L, Capewell A, Gajewski JB, Sand PK; International Consultation on Incontinence 2008 Committee on Dynamic Testing. Executive Summary: The International Consultation on Incontinence 2008--Committee on: "Dynamic Testing"; for urinary or fecal incontinence. Part 3: Anorectal physiology studies. Neurourol Urodyn. 2010;29(1):153-8. doi: 10.1002/nau.20762.

  PMID: 19693957 BACKGROUND

• de Groat WC. Integrative control of the lower urinary tract: preclinical perspective. Br J Pharmacol. 2006 Feb;147 Suppl 2(Suppl 2):S25-40. doi: 10.1038/sj.bjp.0706604.

  PMID: 16465182 BACKGROUND

• Ben-Dror I, Weissman A, Leurer MK, Eldor-Itskovitz J, Lowenstein L. Alterations of heart rate variability in women with overactive bladder syndrome. Int Urogynecol J. 2012 Aug;23(8):1081-6. doi: 10.1007/s00192-012-1738-7. Epub 2012 Apr 11.

  PMID: 22491716 BACKGROUND

• Coyne KS, Zyczynski T, Margolis MK, Elinoff V, Roberts RG. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther. 2005 Jul-Aug;22(4):381-94. doi: 10.1007/BF02850085.

  PMID: 16418145 BACKGROUND

• Banakhar MA, Al-Shaiji TF, Hassouna MM. Pathophysiology of overactive bladder. Int Urogynecol J. 2012 Aug;23(8):975-82. doi: 10.1007/s00192-012-1682-6. Epub 2012 Feb 7.

  PMID: 22310925 BACKGROUND

• Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, Monga A, Petri E, Rizk DE, Sand PK, Schaer GN; International Urogynecological Association; International Continence Society. An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2010;29(1):4-20. doi: 10.1002/nau.20798.

  PMID: 19941278 BACKGROUND

• Fall M, Lindstrom S. Electrical stimulation. A physiologic approach to the treatment of urinary incontinence. Urol Clin North Am. 1991 May;18(2):393-407.

  PMID: 2017820 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Luís T da Rosa, PhD

  Federal University of Health Science of Porto Alegre

  PRINCIPAL INVESTIGATOR

• Caroline HL de Lima, Msc

  Federal University of Health Science of Porto Alegre

  STUDY CHAIR

• Patrícia V da Rosa, PhD

  Federal University of Health Science of Porto Alegre

  STUDY DIRECTOR

• Rodrigo DM Plentz, PhD

  Federal University of Health Science of Porto Alegre

  STUDY DIRECTOR

• Cinara Stein, PhD

  Federal University of Health Science of Porto Alegre

  STUDY CHAIR

• Fabrício E Macagnan, PhD

  Federal University of Health Science of Porto Alegre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor and vice-rector

Study Record Dates

• First Submitted: April 6, 2015
• First Posted: May 28, 2015
• Study Start: March 1, 2014
• Primary Completion: August 1, 2014
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

BR (1)