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| Name | Class |
|---|---|
| Hospital de Clinicas de Porto Alegre | OTHER |
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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.
Goal
Development of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using tibial stimulation and pelvic floor exercises.
Secondary objectives
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "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 |
|
| "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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Urinary incontinence | 3 months |
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Inclusion Criteria:
- Women with Urinary Incontinence of Urgency or Mixed older than 18 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magda Ms Aranchipe, Master | Contact | mchipe@hotmail.com | ||
| Luciana Dr Paiva, PhD | Contact | luciana.paiva@ufrgs.br |
| Name | Affiliation | Role |
|---|---|---|
| Jose Geraldo Dr Ramos, PhD | Federal University of Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Clinicas de Porto Alegre | Recruiting | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 26, 2016 | |
| Reset | Dec 19, 2016 | |
| Release | Jan 16, 2017 | |
| Reset | Mar 3, 2017 | |
| Release | Jun 28, 2017 | |
| Reset | Jan 26, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 26, 2016 | Dec 19, 2016 | |||
| Jan 16, 2017 |
| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Mar 3, 2017 |
| Jun 28, 2017 | Jan 26, 2018 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |