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

Tatiane Gomes de Araujo

Status and phase: Unknown; Early Phase 1

Conditions: Parkinson Disease; Overactive Bladder

Treatments: Device: Back Tibial Nerve Electrostimulation; Device: Placebo Electrostimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02583529

14-0554

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Back Tibial Nerve Electrostimulation

Experimental group

Description:

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.

Treatment:

Device: Back Tibial Nerve Electrostimulation

Placebo Electrostimulation

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo Electrostimulation