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

NCT02452593 | Unknown DMC

• 1 other identifier: UFRGSDGO
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urge Incontinence

Keywords

incontinence; pelvic floor exercises; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Number of participants with Urinary incontinence

  3 months

Study Arms (2)

"Tibial Nerve Stimulation"

ACTIVE COMPARATOR

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"

"Pelvic Floor Exercises"

ACTIVE COMPARATOR

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"

Interventions

"Tibial stimulation" and "pelvic floor exercises" OTHER

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

"Pelvic Floor Exercises"; "Tibial Nerve Stimulation"

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Hospital de Clinicas de Porto Alegre: collaborator

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

MeSH Terms

Conditions

Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; 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

Study Officials

• Jose Geraldo Dr Ramos, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Ms Aranchipe, Master

CONTACT

mchipe@hotmail.com

Luciana Dr Paiva, PhD

CONTACT

luciana.paiva@ufrgs.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: May 22, 2015
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

BR (1)