Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder

NCT ID: NCT03742206

Last Updated: 2018-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-25

Study Completion Date

2019-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Overactive Bladder Urinary Urge Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Parasacral Transcutaneous Electrical Stimulation

Intervention Type DEVICE

Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.

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.

Group Type ACTIVE_COMPARATOR

Transcutaneous Posterior Tibial Nerve Stimulation

Intervention Type DEVICE

Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation

Interventions

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Parasacral Transcutaneous Electrical Stimulation

Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.

Intervention Type DEVICE

Transcutaneous Posterior Tibial Nerve Stimulation

Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of overactive bladder with or without the presence of urinary incontinence.
* Understand the instruments used in the research.

Exclusion Criteria

* Urinary tract infection
* Neurological disease
* Other previous treatment in the last four weeks
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Geraldo Lopes Ramos

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas de Porto Alegre

Locations

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Suzana Mallmann

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Mallmann

Role: CONTACT

+5551996261820

Facility Contacts

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Mallmann

Role: primary

+5551996261820

Other Identifiers

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17-0056

Identifier Type: -

Identifier Source: org_study_id

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