Urinary Bladder, OveractiveNCT03519126
Electrostimulation in the Treatment of Idiopathic Overactive Bladder
A study testing electrostimulation in people with Urinary Bladder, Overactive, run by Janaina Mayer de Oliveira Nunes.
Trial summary
This is a clinical trial whose objective is to compare the efficacy of transcutaneous electrostimulation of the posterior tibial nerve with intravaginal electrostimulation in the treatment of women with symptoms of idiopathic overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- electrostimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- No sites listed yet
- Study dates
- 19 Apr 2016to 30 Mar 2020
- 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
- aged 18 years and over
- literate
- exhibit symptoms of overactive bladder (urinary urgency, urge incontinence, nocturia and polaciuria) or mixed urinary incontinence with predominance of urge incontinence
- to present lower urinary tract dysfunction identified by scores that were equal or higher than 8 points in the Overactive Blader version 8 questionnaire (OAB-V8)
- accept to participate in the study by means of signing the Term of Free and Informed Consent approved by the Research Ethics Committee of the University Hospital of the Northern Region of Paraná State University of Londrina (HURNP / UEL).
Who cannot join
- Women who are virgin
- pregnant
- have a recurrent lower urinary tract infection (more than three episodes a year)
- vaginal infection
- history of overactive bladder medication in the last three months
- urinary incontinence to efforts exclusively
Show all 15Show fewer
- previous surgery to treat incontinence urinary
- neurological diseases (such as multiple sclerosis, Alzheimer's disease, stroke, Parkinson's disease)
- current history of genitourinary neoplasia
- genital prolapse above third degree of Baden and Walker
- decompensated diabetic
- patients with cardiac pacemaker
- metal implant in the ankle and right foot
- cognitive deficit that inability to respond to questionnaires properly and / or correctly fill in the voiding diary
- do not perform all treatment sessions
About this study
Official title: Efficacy of Vaginal and Transcutaneous Electrostimulation of the Posterior Tibial Nerve in the Treatment of Overactive Bladder
This is a clinical trial whose objective is to compare the efficacy of transcutaneous electrostimulation of the posterior tibial nerve with intravaginal electrostimulation in the treatment of women with symptoms of idiopathic overactive bladder. The volunteers will be randomly randomized into three study groups: posterior tibial group, vaginal group and control group. They are evaluated at three times: before the start of treatment, at the end of 6 weeks of treatment and after 1 month (follow up). The evaluation will occur through a voiding diary and a quality of life questionnaire. For the treatment groups will be used depolarized biphasic current with frequency of 10 Hz and pulse width of 200 μs, and intensity according to the tolerance of the patient. The hypothesis of the study is that the two forms of electrostimulation for treatment of idiopathic overactive bladder will be effective, but transcutaneous electrostimulation of the posterior tibial nerve will be more effective than intravaginal.
Read the detailed description
Objective: To compare the efficacy between intravaginal and transcutaneous electrostimulation of the posterior tibial nerve in the treatment of women with symptoms of idiopathic overactive bladder or mixed urinary incontinence.
METHODS: This is a randomized, controlled, single-blind clinical trial with comparative analysis between study groups and a control, performed at three moments: pre and post clinical intervention and one month after the end of treatment. Vaginal electrostimulation group (GV), transcutaneous electrostimulation group of the posterior tibial nerve (GTP) and control group (CG - without intervention). The intervention groups will be treated with biphasic current with a frequency of 10 Hz and a pulse width of 200 μs for 12 sessions of 30 minutes each. Participants will be evaluated and reevaluated by means of a general data questionnaire, 3-day urinary diary and an International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Statistical analysis will be performed using SPSS version 22 and the level of significance adopted will be p <0.05.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- electrostimulation
- Keywords
- Urinary Bladder, Overactive; Electric Stimulation
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrostimulationOther
Electrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs.
| Study group | Role | What they receive |
|---|---|---|
| vaginal | Experimental | Group of volunteers who will be treated with vaginal electrostimulation Receives: Other: electrostimulation |
| posterior tibial nerve | Experimental | Group treated with transcutaneous electrostimulation of the posterior tibial nerve Receives: Other: electrostimulation |
| control | No intervention | Group of volunteers who will not be treated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline miccional emergency at 6 weeks after starting treatment and at 1 month after the end of treatment.
Sudden and uncontrollable desire to urinate checked through the voiding diary.
Measured: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Secondary outcomes (4)
Change from baseline urinary frequency at 6 weeks after starting treatment and at 1 month after the end of treatment.
Urinating often (more than 8 events / 24h)
Measured: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline nocturia at 6 weeks after starting treatment and at 1 month after the end of treatment.
The necessity wake up 1 or more times during the night to urinate.
Measured: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline urge-incontinence at 6 weeks after starting treatment and at 1 month after the end of treatment.
Involuntary loss accompanied or preceded by urine in the immediate aftermath of an emergency episode.
Measured: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline quality of life related to the symptoms of overactive bladder at 6 weeks after starting treatment and at 1 month after the end of treatment.
The impact of overactive bladder symptoms on the quality of life of the volunteers will be verified through the International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB), which is a brief questionnaire with a high psychometric capacity to specifically evaluate overactive bladder. The ICIQ-OAB score ranges from 0 to 16 on a progressive scale, as well as an analog scale from zero to ten to quantify the discomfort caused by each symptom, the higher the score the worse the quality of life.
Measured: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start19 Apr 2016
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Why it stopped: Due to the covid-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized, controlled, simple blind trial with comparative analysis between study groups and a control, performed in three moments: pre and post clinical intervention and one month after the end of treatment (follow up).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janaina Mayer de Oliveira Nunes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Janaina Mayer de Oliveira Nunes, Universidade Federal do Piauí
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519126
- Sponsor's protocol ID
- Overactive bladder
- Status last verified
- Dec 2020
- First submitted
- 12 Apr 2018
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Vaginal and Transcutaneous Electrostimulation of the Posterior Tibial Nerve in the Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT03519126
- Acronym / sponsor ID
- Overactive bladder
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Urinary Bladder, Overactive; Electric Stimulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the covid-19 pandemic
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Janaina Mayer de Oliveira NunesUniversity, hospital or other
- Study start
- 19 Apr 2016 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 8 May 2018 (actual)
- 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.
This is a clinical trial whose objective is to compare the efficacy of transcutaneous electrostimulation of the posterior tibial nerve with intravaginal electrostimulation in the treatment of women with symptoms of idiopathic overactive bladder. The volunteers will be randomly randomized into three study groups: posterior tibial group, vaginal group and control group. They are evaluated at three times: before the start of treatment, at the end of 6 weeks of treatment and after 1 month (follow up). The evaluation will occur through a voiding diary and a quality of life questionnaire. For the treatment groups will be used depolarized biphasic current with frequency of 10 Hz and pulse width of 200 μs, and intensity according to the tolerance of the patient. The hypothesis of the study is that the two forms of electrostimulation for treatment of idiopathic overactive bladder will be effective, but transcutaneous electrostimulation of the posterior tibial nerve will be more effective than intravaginal.
Detailed description
Objective: To compare the efficacy between intravaginal and transcutaneous electrostimulation of the posterior tibial nerve in the treatment of women with symptoms of idiopathic overactive bladder or mixed urinary incontinence.
METHODS: This is a randomized, controlled, single-blind clinical trial with comparative analysis between study groups and a control, performed at three moments: pre and post clinical intervention and one month after the end of treatment. Vaginal electrostimulation group (GV), transcutaneous electrostimulation group of the posterior tibial nerve (GTP) and control group (CG - without intervention). The intervention groups will be treated with biphasic current with a frequency of 10 Hz and a pulse width of 200 μs for 12 sessions of 30 minutes each. Participants will be evaluated and reevaluated by means of a general data questionnaire, 3-day urinary diary and an International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB). Statistical analysis will be performed using SPSS version 22 and the level of significance adopted will be p <0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- It is a randomized, controlled, simple blind trial with comparative analysis between study groups and a control, performed in three moments: pre and post clinical intervention and one month after the end of treatment (follow up).
| Arm | Type | Receives |
|---|---|---|
| vaginal | Experimental | Other: electrostimulationGroup of volunteers who will be treated with vaginal electrostimulation |
| posterior tibial nerve | Experimental | Other: electrostimulationGroup treated with transcutaneous electrostimulation of the posterior tibial nerve |
| control | No intervention | –Group of volunteers who will not be treated |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women
- aged 18 years and over
- literate
- exhibit symptoms of overactive bladder (urinary urgency, urge incontinence, nocturia and polaciuria) or mixed urinary incontinence with predominance of urge incontinence
- to present lower urinary tract dysfunction identified by scores that were equal or higher than 8 points in the Overactive Blader version 8 questionnaire (OAB-V8)
Key exclusion criteria (15 listed)
- Women who are virgin
- pregnant
- have a recurrent lower urinary tract infection (more than three episodes a year)
- vaginal infection
- history of overactive bladder medication in the last three months
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 |
|---|---|---|
| electrostimulationElectrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs. | Other | posterior tibial nerve, vaginal |
Primary outcome
Change from baseline miccional emergency at 6 weeks after starting treatment and at 1 month after the end of treatment.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Sudden and uncontrollable desire to urinate checked through the voiding diary.
4 secondary outcomes
Change from baseline urinary frequency at 6 weeks after starting treatment and at 1 month after the end of treatment.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline nocturia at 6 weeks after starting treatment and at 1 month after the end of treatment.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline urge-incontinence at 6 weeks after starting treatment and at 1 month after the end of treatment.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Change from baseline quality of life related to the symptoms of overactive bladder at 6 weeks after starting treatment and at 1 month after the end of treatment.
Time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.
Results and safety
The study was stopped early (reason given: Due to the covid-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing electrostimulation in people with Urinary Bladder, Overactive, run by Janaina Mayer de Oliveira Nunes.
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 6 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was stopped early (reason given: Due to the covid-19 pandemic). Results are not available in the source record.
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 from baseline miccional emergency at 6 weeks after starting treatment and at 1 month after the end of treatment. (time frame: Before starting treatment, 6 weeks after starting treatment and 1 month after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Dec 2020.