Clinical trial NCT02583529: Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
Official title: Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Overactive Bladder
Parkinson Disease
Keywords: Parkinson Disease
Neurogenic Overactive Bladder
Posterior Tibial Nerve Electrostimulation
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Voiding diary
timeFrame: 3 months
Secondary outcomes:
measure: Hoehn and Yahr Disability Stage of scale
timeFrame: 3 months
measure: King's Health Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Tatiane Gomes de Araujo
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Jose Geraldo Lopes Ramos
role: PRINCIPAL_INVESTIGATOR
References:
citation: Araujo TG, Schmidt AP, Sanches PRS, Silva Junior DP, Rieder CRM, Ramos JGL. Transcutaneous tibial nerve home stimulation for overactive bladder in women with Parkinson's disease: A randomized clinical trial. Neurourol Urodyn. 2021 Jan;40(1):538-548. doi: 10.1002/nau.24595. Epub 2020 Dec 16.