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

October 20, 2015 updated by: Tatiane Gomes de Araujo
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-052
        • Recruiting
        • Tatiane Gomes de Araujo
        • Principal Investigator:
          • José Geraldo Lopes Ramos
        • Contact:
          • Tatiane Gomes de Araujo
          • Phone Number: 51 82086083
        • Contact:
          • Tatiane Gomes de Araujo
          • Phone Number: 51 33645021
        • Principal Investigator:
          • Carlor Roberto de Mello Rieder
        • Sub-Investigator:
          • Pedro Schestatsky
        • Sub-Investigator:
          • Adriana Prato Schmidt
        • Sub-Investigator:
          • Paulo Roberto Stefani Sanches
        • Sub-Investigator:
          • Danton Pereira da Silva Jr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hoehn and Yahr Disability Stage of scale
Time Frame: 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).
3 months
King's Health Questionnaire
Time Frame: 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).
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tatiane Gomes de Araujo

Investigators

  • Principal Investigator: Jose Geraldo Lopes Ramos, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 26, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Estimate)

October 22, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0554

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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