Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
Trial Snapshot
- Phase
- Early Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Voiding diary
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Voiding diary
Time Frame: 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 Outcomes
- King's Health Questionnaire(3 months)
- Hoehn and Yahr Disability Stage of scale(3 months)
Investigators
Tatiane Gomes de Araujo
MD
Hospital de Clinicas de Porto Alegre