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

Early Phase 1

• Conditions: Overactive Bladder; Parkinson Disease
• Interventions: Device: Back Tibial Nerve Electrostimulation; Device: Placebo Electrostimulation

• Registration Number: NCT02583529
• Lead Sponsor: Tatiane Gomes de Araujo

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-09-26
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-20
• Last Update Submitted: 2015-10-20
• Study First Posted: 2015-10-22
• Last Update Posted: 2015-10-22
• Primary Completion: 2016-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Back Tibial Nerve Electrostimulation	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.
Placebo Electrostimulation	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.

Primary Outcome Measures

Name	Time	Method
Voiding diary	3 months	Consists of daily annotation fluid intake, frequency (number) and volume of urination (mL), daily activities and episodes of incontinence (number), need and number of hygienic protections, etc. It is a cost-effective method of initially assessing urinary complaints when compared to the test pad (pad test) and standardized symptom scales.The voiding diary will be filled before and after treatment that will last 03 months (baseline and 3 months). The patient will record your urinary habits for one day (24 hours) before starting treatment and after completion.

Secondary Outcome Measures

Name	Time	Method
King's Health Questionnaire	3 months	The questionnaire presents 32 items distributed into 10 domains and is available in 26 languages. A change from baseline of 5 points (out of 100) in any field indicates significant clinical improvement. KHQ is applied before and after treatment (baseline and 3 months).
Hoehn and Yahr Disability Stage of scale	3 months	Developed in 1967, called the DP indication of the general state of the patient. It comprises five phases (Table 1). On this scale, patients classified in stages 1, 2 and 3 show mild to moderate disability, while in stages 4 and 5 show more severe disability. HY is applied before treatment (baseline).

Trial Locations

Locations (1)

Tatiane Gomes de Araujo; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil