Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
NOVTPD
1 other identifier
interventional
30
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2014
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedOctober 22, 2015
October 1, 2015
2.4 years
September 26, 2015
October 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (2)
Hoehn and Yahr Disability Stage of scale
3 months
King's Health Questionnaire
3 months
Study Arms (2)
Back Tibial Nerve Electrostimulation
EXPERIMENTALThey 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 COMPARATORThey 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tatiane Gomes de Araujo
Porto Alegre, Rio Grande do Sul, 90035-052, Brazil
Related Publications (1)
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.
PMID: 33326648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Geraldo Lopes Ramos
Federal University of Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 26, 2015
First Posted
October 22, 2015
Study Start
July 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2017
Last Updated
October 22, 2015
Record last verified: 2015-10