Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-01-03 @ 4:33 AM
Study NCT ID:
NCT02452593
Status:
UNKNOWN
Last Update Posted:
2015-05-22
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder
Sponsor:
Federal University of Rio Grande do Sul
Organization:
Study Overview
Official Title:
Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder, Urge and Mixed Urinary Incontinence
Status:
UNKNOWN
Status Verified Date:
2015-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: