Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder
Study Details
Study Description
Brief Summary
Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women.
Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed
Main outcome: to measure changes in urinary urgency and quality of life.
Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Parasacral Parasacral Transcutaneous Electrical Stimulation Group: participants in this group will receive two self-adhesive electrodes and will be instructed to position them in the sacral region. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks. |
Device: Parasacral Transcutaneous Electrical Stimulation
Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.
|
| Active Comparator: Posterior Tibial Nerve Transcutaneous Posterior Tibial Nerve Stimulation Group: participants in this group will receive a neoprene ankle brace that will be connected to the electrostimulator. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks. |
Device: Transcutaneous Posterior Tibial Nerve Stimulation
Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation
|
Outcome Measures
Primary Outcome Measures
- Efficacy of treatment in quality of life [six weeks]
Application of the King's Health Questionnaire (KHQ). KHQ is an instrument for measuring quality of life in people diagnosed with urinary incontinence, consisting of 30 objective questions distributed in 9 domains. In each question, values are assigned according to the intensity of the patient's complaint (0 = not applicable, 1 = no; 2 = a little / sometimes, 3 = more or less / several times, 4 = a lot / always). The final score is calculated individually for each domain and ranges from 0 to 100, the highest score being related to a poorer quality of life.
Secondary Outcome Measures
- Severity of urinary incontinence [six weeks]
Application of the Incontinence Severity Index. It is a brief instrument, consisting of two questions regarding the frequency and amount of urinary loss. The final score obtained by multiplying the frequency scores by the amount of urinary loss allows the incontinence urinary to be classified as mild (final score 1-2), moderate (final score 3-6 ), severe (final score 8-9) and very severe (final score 12).
- Severity of overactive bladder symptoms [six weeks]
Application of the Symptom Bother Scale. It instrument asks how bothered the patient is by the 4 hallmark symptoms of overactive bladder: urinary frequency, urgency, nocturia, and urge incontinence. Patients respond on a 6-point Likert scale ranging from 0 (not at all) to 5 (a very great deal), with a maximum possible score of 40, calculated by adding all responses.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of overactive bladder with or without the presence of urinary incontinence.
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Understand the instruments used in the research.
Exclusion Criteria:
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Urinary tract infection
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Neurological disease
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Other previous treatment in the last four weeks
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Suzana Mallmann | Porto Alegre | Rio Grande Do Sul | Brazil |
Sponsors and Collaborators
- Hospital de Clinicas de Porto Alegre
Investigators
- Principal Investigator: José Geraldo Lopes Ramos, Hospital de Clínicas de Porto Alegre
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17-0056