Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation

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

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-12-31

Brief Summary

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Dysfunctions of the lower urinary tract are non-motor symptoms common engines in Parkinson's disease (PD). Urodynamic changes in PD include overactive bladder (OB), characterized by urgency with or without urge incontinence , usually with frequency and nocturia . The aim of this study is to evaluate the efficacy and effectiveness of the treatment of OB in patients with PD with the use of a specific treatment: Posterior Tibial Nerve Electrostimulation (PTNE).

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Detailed Description

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Introduction: Dysfunctions of the lower urinary tract are non-motor symptoms common engines in Parkinson's disease (PD). Urodynamic changes in PD include overactive bladder (OB), characterized by urgency with or without urge incontinence , usually with frequency and nocturia . The aim of this study is to evaluate the efficacy and effectiveness of the treatment of OB in patients with PD with the use of a specific treatment: Posterior Tibial Nerve Electrostimulation (PTNE). Materials and methods: This is test-clinical, double-blind, randomized, controlled comparison with placebo. The research will be conducted with patients diagnosed with PD and symptoms of OB in the Clinical Hospital of Porto Alegre, in the Movement Disorders and Urogynecology Ambulatories. The patients are divided into two groups, one of which receives placebo stimulation (often below the therapeutic threshold). They will be assessed before and after 12 weeks of treatment with home PTNE through specific form of questionnaires assessing incontinence, quality of life and voiding diary. After the end of treatment will be made up of patients to verify the effectiveness of treatment in 30 to 90 days. Hypothesis: Through this research the investigators hope to determine the true efficacy of this treatment method with PTNE in OB in PD with a high level of evidence, seeking to improve urinary symptoms and quality of life in this patient population.

Conditions

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Overactive Bladder Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Back Tibial Nerve Electrostimulation

They will be assessed before and after 12 weeks of treatment with home PTNE through specific form of questionnaires assessing incontinence, quality of life and voiding diary. After the end of treatment will be made up of patients to verify the effectiveness of treatment in 30 to 90 days.

Group Type EXPERIMENTAL

Back Tibial Nerve Electrostimulation

Intervention Type DEVICE

The BTNE will be made with electrodes Silver Spike Point (SSP) set in an ankle with the negative pole positioned on the inner malleolus and the positive approximately 05 cm below the previous, and connected to a portable stimulator powered by rechargeable battery developed by the Biomedical Engineering Department of the HCPA.

Placebo Electrostimulation

They will be assessed before and after 12 weeks of treatment with home PTNE through specific form of questionnaires assessing incontinence, quality of life and voiding diary. After the end of treatment will be made up of patients to verify the effectiveness of treatment in 30 to 90 days.

Group Type PLACEBO_COMPARATOR

Placebo Electrostimulation

Intervention Type DEVICE

The BTNPE will be made with electrodes Silver Spike Point (SSP) set in an ankle with the negative pole positioned on the inner malleolus and the positive approximately 05 cm below the previous, and connected to a portable stimulator powered by rechargeable battery developed by the Biomedical Engineering Department of the HCPA.

Interventions

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Back Tibial Nerve Electrostimulation

The BTNE will be made with electrodes Silver Spike Point (SSP) set in an ankle with the negative pole positioned on the inner malleolus and the positive approximately 05 cm below the previous, and connected to a portable stimulator powered by rechargeable battery developed by the Biomedical Engineering Department of the HCPA.

Intervention Type DEVICE

Placebo Electrostimulation

The BTNPE will be made with electrodes Silver Spike Point (SSP) set in an ankle with the negative pole positioned on the inner malleolus and the positive approximately 05 cm below the previous, and connected to a portable stimulator powered by rechargeable battery developed by the Biomedical Engineering Department of the HCPA.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of PD according to the criteria of the London Brain Bank
* Complaint urinary storage symptoms such as urinary urgency (sudden urge, abrupt and imperious to urinate, which is difficult to be inhibited), with or without urge incontinence (urine leakage after emergency), frequency (number of urination\> 7 / day) and nocturia (the number of micturitions\> 1 / night).

Exclusion Criteria

* Damage to the peripheral sacral nerves
* Infection of the lower urinary tract untreated;
* Diabetes Mellitus;
* Chronic pulmonary disease worsened;
* Pregnancy and postpartum;
* Urinary Incontinence of pure stress incontinence or urinary Mixed with predominance of the stress component;
* Pacemaker or defibrillator;
* Metal prostheses;
* Application of botulinum toxin into the bladder and / or pelvic muscles last year;
* Current TENS treatment in the pelvic region, lower back and / or legs;
* Prior Urinary incontinence surgery;
* Current bladder carcinoma;
* Cognitive impairment likely to prevent implementation of the proposed treatment;
* Not understand / sign informed consent.

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No