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Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02452593
Recruitment Status : Unknown
Verified May 2015 by Magda da Silva Aranchipe, Federal University of Rio Grande do Sul.
Recruitment status was:  Recruiting
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Collaborator:
Hospital de Clinicas de Porto Alegre
Information provided by (Responsible Party):
Magda da Silva Aranchipe, Federal University of Rio Grande do Sul

Brief Summary:

Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women's lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency.

The overactive bladder present in urge incontinence and mixed cause significant impacts on people's lives and has a prevalence of 16.5% in the US population.

Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment. Drug therapy using drugs which are not specific for the bladder and are associated with many unwanted systemic side effects.

The results obtained by researchers in several countries using conservative techniques in the treatment of patients with urinary incontinence are encouraging and this study aims to evaluate carefully and systematically the effectiveness of tibial stimulation technique.

Importantly, also, that conservative techniques have lower cost than the surgical treatment and have virtually no side effects as most of the drugs used in the pharmacological treatment of female urinary incontinence.


Condition or disease Intervention/treatment Phase
Urge Incontinence Other: "Tibial stimulation" and "pelvic floor exercises" Not Applicable

Detailed Description:

Goal

Development of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using tibial stimulation and pelvic floor exercises.

Secondary objectives

  • Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point).
  • Comparison of the effectiveness of tibial stimulation techniques and pelvic floor exercises in the treatment of overactive bladder and urgency / mixed incontinence.

Design Randomized Clinical Trial

Sample Women over the age of 18, complaining of urinary incontinence Urgency or Mixed (with main urgency component), catered in Urogynecology Ambulatory of Hospital de Clinicas de Porto Alegre.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder, Urge and Mixed Urinary Incontinence
Study Start Date : January 2014
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: "Tibial Nerve Stimulation"

This group will do transcutaneous electrical stimulation of the tibial nerve at home.

Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point). Frequency: 20 Hz, Pulse width: 200 us; duration: 15min daily

Other: "Tibial stimulation" and "pelvic floor exercises"
A group will make tibial nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks

Active Comparator: "Pelvic Floor Exercises"
This group will make pelvic muscle training 3 times a day . In decubit dorsal posture, legs flexed and abductee. Perform pelvic floor contractions keeping 2 seconds and relaxing 4 seconds for 10 times, and contractions keeping 4 seconds and relaxing 8 seconds for 10 times.
Other: "Tibial stimulation" and "pelvic floor exercises"
A group will make tibial nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks




Primary Outcome Measures :
  1. Number of participants with Urinary incontinence [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Women with Urinary Incontinence of Urgency or Mixed older than 18 years

Exclusion Criteria:

  • Presence Of vaginal or urinary infection
  • Not understand or sign the informed consent
  • Not understand or are unable to perform the proposed treatment
  • Pregnancy or the postpartum period covering the period up to 6 months after delivery
  • Women in previous use of chronically used drugs (antidepressants, diuretics, and others) that can evidently alter the urinary function.
  • Stress Urinary Incontinence of pure or mixed incontinence with a predominance of Stress component neurogenic bladder
  • Use of Botox® in the bladder or pelvic muscles in the last year
  • Use Interstim® or Bion®
  • Use pacemaker or implantable defibrillator
  • Current use of TENS in the pelvic region, lower back or legs
  • Previous use of percutaneous tibial stimulation
  • Drug / experimental devices in the past 4 weeks,
  • Participation in any clinical research involving or affecting the urinary or renal function in the last 4 weeks.
  • Pelvic radiotherapy;
  • Changes in sensibility Lower Limb;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02452593


Contacts
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Contact: Magda Ms Aranchipe, Master mchipe@hotmail.com
Contact: Luciana Dr Paiva, PhD luciana.paiva@ufrgs.br

Locations
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Brazil
Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Contact: Magda Aranchipe       mchipe@hotmail.com   
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Jose Geraldo Dr Ramos, PhD Federal University of Rio Grande do Sul

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Responsible Party: Magda da Silva Aranchipe, Researcher, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02452593    
Other Study ID Numbers: UFRGSDGO
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: May 22, 2015
Last Verified: May 2015
Keywords provided by Magda da Silva Aranchipe, Federal University of Rio Grande do Sul:
incontinence; pelvic floor exercises; neuromodulation
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Incontinence
Urination Disorders