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

Primary Purpose

Overactive Bladder, Parkinson Disease

Status
Unknown status
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Back Tibial Nerve Electrostimulation
Placebo Electrostimulation
Sponsored by
Tatiane Gomes de Araujo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Parkinson Disease, Neurogenic Overactive Bladder, Posterior Tibial Nerve Electrostimulation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Tatiane Gomes de AraujoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Back Tibial Nerve Electrostimulation

Placebo Electrostimulation

Arm 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.

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.

Outcomes

Primary Outcome Measures

Voiding diary
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

Hoehn and Yahr Disability Stage of scale
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).
King's Health Questionnaire
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).

Full Information

First Posted
September 26, 2015
Last Updated
October 20, 2015
Sponsor
Tatiane Gomes de Araujo
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1. Study Identification

Unique Protocol Identification Number
NCT02583529
Brief Title
Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
Acronym
NOVTPD
Official Title
Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tatiane Gomes de Araujo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder, Parkinson Disease
Keywords
Parkinson Disease, Neurogenic Overactive Bladder, Posterior Tibial Nerve Electrostimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Back Tibial Nerve Electrostimulation
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Electrostimulation
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Back Tibial Nerve Electrostimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Placebo Electrostimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Voiding diary
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Hoehn and Yahr Disability Stage of scale
Description
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).
Time Frame
3 months
Title
King's Health Questionnaire
Description
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).
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiane Gomes de Araujo, Brazil
Phone
51 82086083
Email
tatinhaga@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Tatiane Gomes de Araujo
Phone
51 33645021
Email
tatinhaga@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Geraldo Lopes Ramos
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tatiane Gomes de Araujo
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-052
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tatiane Gomes de Araujo
Phone
51 82086083
First Name & Middle Initial & Last Name & Degree
Tatiane Gomes de Araujo
Phone
51 33645021
First Name & Middle Initial & Last Name & Degree
José Geraldo Lopes Ramos
First Name & Middle Initial & Last Name & Degree
Carlor Roberto de Mello Rieder
First Name & Middle Initial & Last Name & Degree
Pedro Schestatsky
First Name & Middle Initial & Last Name & Degree
Adriana Prato Schmidt
First Name & Middle Initial & Last Name & Degree
Paulo Roberto Stefani Sanches
First Name & Middle Initial & Last Name & Degree
Danton Pereira da Silva Jr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
33326648
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.
Results Reference
derived

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

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