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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"
Sponsored by
Federal University of Rio Grande do Sul
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

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
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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
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
Arm Title
"Pelvic Floor Exercises"
Arm Type
Active Comparator
Arm Description
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.
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
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
Email
mchipe@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana Dr Paiva, PhD
Email
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
Email
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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