Overactive Bladder SyndromeNCT01912885
Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome
A study testing TENS 1-1, TENS 1-2 and TENS 2-1 in people with Overactive Bladder Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society as urgency, with or without incontinence, usually with increased urinary frequency and nocturia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder Syndrome
- What is being tested?
- TENS 1-1, TENS 1-2 and TENS 2-1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Oct 2013to 25 Sep 2014
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women with 18 years of age or more;
- Cognitive level adequate for understanding orientations during treatment;
- Clinical diagnosis of overactive bladder syndrome for at least six months prior to the study.
Who cannot join
- Pregnant women or women who wish to get pregnant;
- Neurological disease;
- Urinary infection;
- Nephrolithiasis;
- Stress urinary incontinence;
- Mixed urinary incontinence;
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- Women in pharmacological treatment for overactive bladder syndrome;
- Women undergoing hormone replacement therapy in the last six months;
- Peripheral neuropathy;
- Cystocele stage two or higher.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Gynecology Ambulatory of the General Hospital of the Faculty of Medicine of the University of Sao Paulo
São Paulo, 05403000
About this study
Official title: Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome: Randomized Blind Clinical Trial
INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society as urgency, with or without incontinence, usually with increased urinary frequency and nocturia. It is difficult to estimate the prevalence of this syndrome because many patients do not seek medical help, despite considerable negative impact on quality of life. Lower urinary tract dysfunctions can be treated using electrical stimulation of the posterior tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary frequency and nocturia . Due to lack of consensus on the parameters of this technique, further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will accept up to 145 women with overactive bladder diagnosis for at least six months prior to the beginning of the study. The subjects will be divided into five groups: group TENS 0-1 (placebo group), group TENS 1-1 (electrical stimulation of one leg once a week), group TENS 1-2 (electrical stimulation of one leg twice a week), group TENS 2-1 (electrical stimulation of two legs one a week) and group TENS 2-2 (electrical stimulation of two legs twice a week). Physical evaluation will be done at the beginning and at the end of the treatment. Evaluation will be done using the King "s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for follow-up treatment.
Read the detailed description
Participants will be recruited from Urogynecology Physical Therapy Outpatient Clinic of a university hospital and randomly assigned using website www.randomization.com and distributed into five groups considering the sites of application and frequency of attendanc, listed above.
Data will be collected by the investigator using interview and physical examination and will be safely stored in computer.
For this study, in terms of urinary frequency, the standard deviation was estimated at 3.25 episodes of urinary urgency (SD=3.25). With 80% power and 95% confidence, the sample size calculation was 25 women in each group, plus a possible sample loss of around 20%, resulting in a sample size of 29 women per group, for a total of 145 patients in the study.
The chi-square test was used to assess whether there was an association between sample description variables and treatments. The analysis of variance F-test was used to assess whether there were differences in the numerical descriptive variables between treatment groups. The nonparametric Kruskal-Wallis test was used to compare treatments in terms of the difference between before and after for each quality of life and voiding diary variables. If there was statistical significance, the Dunn multiple comparison test was performed, with p-values of less than 0.05 considered significant. The analysis of variance model with repeated measures was used to compare data from the specific voiding diary according to the treatment groups and sessions. Significant comparisons were evaluated with Tukey post-hoc test. To approximate data to the normality, a 1/log (variable+1) transformation was done. For the follow up analysis, it was used the ANOVA three ways, with Holm Sidak post-hoc test for comparison of scores. All the statistical tests developed were based on a significance of 5%, i.e., the null hypothesis was rejected when the p-value was less than 0.05.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- TENS 1-1, TENS 1-2, TENS 2-1, TENS 2-2, TENS 0-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS 1-1Device
Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg once a week.
TENS 1-2Device
Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg twice a week.
TENS 2-1Device
Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs once a week.
TENS 2-2Device
Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs twice a week.
TENS 0-1Device
Placebo: application os electrodes of Transcutaneous Electrical Nerve Stimulation on one leg once a week, without turning on the device.
| Study group | Role | What they receive |
|---|---|---|
| Group TENS 0-1 | Placebo comparator | Electrodes will be fixated to one leg and sessions will be held once a week. Receives: Device: TENS 0-1 |
| Group TENS 1-1 | Experimental | Electrical stimulation of the posterior tibial nerve of one leg once a week. Receives: Device: TENS 1-1 |
| Group TENS 1-2 | Experimental | Electrical stimulation of the posterior tibial nerve of one leg twice a week. Receives: Device: TENS 1-2 |
| Group TENS 2-1 | Experimental | Electrical stimulation of the posterior tibial nerve of two legs once a week. Receives: Device: TENS 2-1 |
| Group TENS 2-2 | Experimental | Electrical stimulation of the posterior tibial nerve of two legs twice a week. Receives: Device: TENS 2-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in urinary frequence in 12 sessions.
Number of micturitions per day.
Measured: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Secondary outcomes (3)
Change in Nocturia in 12 sessions.
Number of micturitions per night, interrupting sleep.
Measured: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Change in urinary urgence in 12 sessions.
Number of urgent micturitions per day.
Measured: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Change in urinary urge-incontinence in 12 sessions.
Number of leaks per day.
Measured: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study start9 Oct 2013
- Primary completion25 Aug 2014
- Study completion25 Sep 2014
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 Bladder SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth AG Ferreira, PhD, Study director, Faculty of Medicine, University of São Paulo, São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912885
- Sponsor's protocol ID
- MunickP
- Status last verified
- Dec 2017
- First submitted
- 5 Jun 2013
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Pierre ML, Friso B, Casarotto RA, Haddad JM, Baracat EC, Ferreira EAG. Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment. Clinics (Sao Paulo). 2021 Aug 16;76:e3039. doi: 10.6061/clinics/2021/e3039. eCollection 2021.
PubMed 34406271
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posterior Tibial Nerve Electrical Stimulation Protocols for Overactive Bladder Syndrome: Randomized Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT01912885
- Acronym / sponsor ID
- MunickP
- Conditions
- Overactive Bladder Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 9 Oct 2013 (actual)
- Primary completion
- 25 Aug 2014 (actual)
- Study completion
- 25 Sep 2014 (actual)
- First posted
- 31 Jul 2013 (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.
INTRODUCTION: Overactive bladder syndrome is defined by The International Continence Society as urgency, with or without incontinence, usually with increased urinary frequency and nocturia. It is difficult to estimate the prevalence of this syndrome because many patients do not seek medical help, despite considerable negative impact on quality of life. Lower urinary tract dysfunctions can be treated using electrical stimulation of the posterior tibial nerve. This therapy is conservative, effective, inexpensive and promotes high adhesion to treatment. It has good results, decreasing symptoms of urgency, urge-incontinence, urinary frequency and nocturia . Due to lack of consensus on the parameters of this technique, further research is necessary. OBJECTIVE: To compare the effectiveness of protocols for the electrical stimulation of the posterior tibial nerve for treatment of non-neurogenic overactive bladder. METHODS: The study was a blind randomized clinical trial. The study will accept up to 145 women with overactive bladder diagnosis for at least six months prior to the beginning of the study. The subjects will be divided into five groups: group TENS 0-1 (placebo group), group TENS 1-1 (electrical stimulation of one leg once a week), group TENS 1-2 (electrical stimulation of one leg twice a week), group TENS 2-1 (electrical stimulation of two legs one a week) and group TENS 2-2 (electrical stimulation of two legs twice a week). Physical evaluation will be done at the beginning and at the end of the treatment. Evaluation will be done using the King "s Health Questionnaire, the International Consultation Incontinence Questionnaire - Short Form, the Overactive Bladder Questionnaire, a three day urinary diary and a table for follow-up treatment.
Detailed description
Participants will be recruited from Urogynecology Physical Therapy Outpatient Clinic of a university hospital and randomly assigned using website www.randomization.com and distributed into five groups considering the sites of application and frequency of attendanc, listed above.
Data will be collected by the investigator using interview and physical examination and will be safely stored in computer.
For this study, in terms of urinary frequency, the standard deviation was estimated at 3.25 episodes of urinary urgency (SD=3.25). With 80% power and 95% confidence, the sample size calculation was 25 women in each group, plus a possible sample loss of around 20%, resulting in a sample size of 29 women per group, for a total of 145 patients in the study.
The chi-square test was used to assess whether there was an association between sample description variables and treatments. The analysis of variance F-test was used to assess whether there were differences in the numerical descriptive variables between treatment groups. The nonparametric Kruskal-Wallis test was used to compare treatments in terms of the difference between before and after for each quality of life and voiding diary variables. If there was statistical significance, the Dunn multiple comparison test was performed, with p-values of less than 0.05 considered significant. The analysis of variance model with repeated measures was used to compare data from the specific voiding diary according to the treatment groups and sessions. Significant comparisons were evaluated with Tukey post-hoc test. To approximate data to the normality, a 1/log (variable+1) transformation was done. For the follow up analysis, it was used the ANOVA three ways, with Holm Sidak post-hoc test for comparison of scores. All the statistical tests developed were based on a significance of 5%, i.e., the null hypothesis was rejected when the p-value was less than 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group TENS 0-1 | Placebo comparator | Device: TENS 0-1Electrodes will be fixated to one leg and sessions will be held once a week. |
| Group TENS 1-1 | Experimental | Device: TENS 1-1Electrical stimulation of the posterior tibial nerve of one leg once a week. |
| Group TENS 1-2 | Experimental | Device: TENS 1-2Electrical stimulation of the posterior tibial nerve of one leg twice a week. |
| Group TENS 2-1 | Experimental | Device: TENS 2-1Electrical stimulation of the posterior tibial nerve of two legs once a week. |
| Group TENS 2-2 | Experimental | Device: TENS 2-2Electrical stimulation of the posterior tibial nerve of two legs twice a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women with 18 years of age or more;
- Cognitive level adequate for understanding orientations during treatment;
- Clinical diagnosis of overactive bladder syndrome for at least six months prior to the study.
Key exclusion criteria (10 listed)
- Pregnant women or women who wish to get pregnant;
- Neurological disease;
- Urinary infection;
- Nephrolithiasis;
- Stress urinary incontinence;
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 |
|---|---|---|
| TENS 1-1Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg once a week. | Device | Group TENS 1-1 |
| TENS 1-2Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg twice a week. | Device | Group TENS 1-2 |
| TENS 2-1Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs once a week. | Device | Group TENS 2-1 |
| TENS 2-2Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs twice a week. | Device | Group TENS 2-2 |
| TENS 0-1Placebo: application os electrodes of Transcutaneous Electrical Nerve Stimulation on one leg once a week, without turning on the device. | Device | Group TENS 0-1 |
Primary outcome
Change in urinary frequence in 12 sessions.
Time frame: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Number of micturitions per day.
3 secondary outcomes
Change in Nocturia in 12 sessions.
Time frame: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Change in urinary urgence in 12 sessions.
Time frame: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Change in urinary urge-incontinence in 12 sessions.
Time frame: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 34406271Pierre ML, Friso B, Casarotto RA, Haddad JM, Baracat EC, Ferreira EAG. Comparison of transcutaneous electrical tibial nerve stimulation for the treatment of overactive bladder: a multi-arm randomized controlled trial with blinded assessment. Clinics (Sao Paulo). 2021 Aug 16;76:e3039. doi: 10.6061/clinics/2021/e3039. eCollection 2021.
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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.
Elizabeth AG Ferreira, PhD study director
Faculty of Medicine, University of São Paulo, São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS 1-1, TENS 1-2 and TENS 2-1 in people with Overactive Bladder Syndrome, run by University of Sao Paulo General Hospital 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 15 Feb 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in urinary frequence in 12 sessions. (time frame: The patients fill in a bladder diary of 3 days running. One bladder diary starting in the first session and the last one to end in the last session.). 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 NCT01912885, 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 15 Feb 2019.