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

Primary Purpose

Urge Incontinence

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

"Tibial stimulation" and "pelvic floor exercises"

About this trial

This is an interventional treatment trial for Urge Incontinence focused on measuring incontinence; pelvic floor exercises; neuromodulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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;

Sites / Locations

Hospital de Clinicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

"Tibial Nerve Stimulation"

"Pelvic Floor Exercises"

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Number of participants with Urinary incontinence

Secondary Outcome Measures

Full Information

NCT ID

NCT02452593

First Posted

April 8, 2015

Last Updated

May 21, 2015

Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital de Clinicas de Porto Alegre

1. Study Identification

Unique Protocol Identification Number

NCT02452593

Brief Title

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

Official Title

Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder, Urge and Mixed Urinary Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

July 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Rio Grande do Sul

Collaborators

Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urge Incontinence

Keywords

incontinence; pelvic floor exercises; neuromodulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

"Tibial Nerve Stimulation"

Arm Type

Active Comparator

Arm Description

Arm Title

"Pelvic Floor Exercises"

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

"Tibial stimulation" and "pelvic floor exercises"

Intervention Description

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 Measure Information:

Title

Number of participants with Urinary incontinence

Time Frame

3 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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;

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Magda Ms Aranchipe, Master

mchipe@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Luciana Dr Paiva, PhD

luciana.paiva@ufrgs.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Geraldo Dr Ramos, PhD

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital de Clinicas de Porto Alegre

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90035-903

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Magda Aranchipe

mchipe@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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