Overactive BladderEarly Phase 1NOVTPDNCT02583529
Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
A Early Phase 1 study testing Back Tibial Nerve Electrostimulation in people with Overactive Bladder and Parkinson Disease, run by Tatiane Gomes de Araujo at 1 site in Brazil.
Trial 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 . Read more about this study
- Who is it for?
- Ages 40 to 90 years, women only
- Conditions the study is for
- Overactive Bladder, Parkinson Disease
- What is being tested?
- Back Tibial Nerve Electrostimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Dec 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Tatiane Gomes de Araujo
Porto Alegre, Rio Grande do Sul, 90035-052
Tatiane Gomes de Araujo, 51 82086083
Tatiane Gomes de Araujo, 51 33645021
About this study
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).
Read the 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.
- Conditions
- Overactive Bladder, Parkinson Disease
- Being tested
- Back Tibial Nerve Electrostimulation, Placebo Electrostimulation
- Keywords
- Parkinson Disease, Neurogenic Overactive Bladder, Posterior Tibial Nerve Electrostimulation
- Medical subject headings
- Urinary Bladder, Overactive, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back Tibial Nerve ElectrostimulationDevice
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 ElectrostimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Back Tibial Nerve Electrostimulation | Experimental | 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. Receives: Device: Back Tibial Nerve Electrostimulation |
| Placebo Electrostimulation | Placebo comparator | 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. Receives: Device: Placebo Electrostimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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).
Measured: 3 months
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).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tatiane Gomes de Araujo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tatiane Gomes de Araujo, Hospital de Clinicas de Porto Alegre
- Investigators
- Jose Geraldo Lopes Ramos, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583529
- Sponsor's protocol ID
- 14-0554
- Acronym
- NOVTPD
- Status last verified
- Oct 2015
- First submitted
- 26 Sep 2015
- Last updated
- 22 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33326648
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurogenic Overactive Bladder Treatment on Parkinson's Disease Through Back Tibial Nerve Electrostimulation
- ClinicalTrials.gov ID
- NCT02583529
- Acronym / sponsor ID
- NOVTPD / 14-0554
- Conditions
- Overactive Bladder, Parkinson Disease
- Keywords
- Parkinson Disease, Neurogenic Overactive Bladder, Posterior Tibial Nerve Electrostimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tatiane Gomes de AraujoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back Tibial Nerve Electrostimulation | Experimental | Device: Back Tibial Nerve ElectrostimulationThey 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 comparator | Device: Placebo ElectrostimulationThey 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. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (14 listed)
- Damage to the peripheral sacral nerves
- Infection of the lower urinary tract untreated;
- Diabetes Mellitus;
- Chronic pulmonary disease worsened;
- Pregnancy and postpartum;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Back Tibial Nerve ElectrostimulationThe 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. | Device | Back Tibial Nerve Electrostimulation |
| Placebo ElectrostimulationThe 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. | Device | Placebo Electrostimulation |
Primary outcome
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.
2 secondary outcomes
Hoehn and Yahr Disability Stage of scale
Time frame: 3 months
King's Health Questionnaire
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2015.
- Derived from this study: PubMed 33326648Araujo 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.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Geraldo Lopes Ramos principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Back Tibial Nerve Electrostimulation in people with Overactive Bladder and Parkinson Disease, run by Tatiane Gomes de Araujo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiane Gomes de Araujo, Brazil (51 82086083, tatinhaga@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Voiding diary (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02583529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2015.