Urinary Incontinence, UrgeTibialTNSNCT05590481
Effect of Tibial Transcutaneous Electrostimulation in Women with Urgency Urinary Incontinence
A study testing TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION and behavioral therapy protocol in people with Urinary Incontinence, Urge, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
Urge urinary incontinence (UUI) is associated with nocturia, a common cause of sleep disorders, also related to levels of anxiety and depression. Studies demonstrate improvement in the clinical parameters of women with UUI after treatment with transcutaneous tibial nerve stimulation (TTNS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Urge
- What is being tested?
- TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION and behavioral therapy protocol
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteBrazil
- Study dates
- 23 Jan 2023to 30 Dec 2023
- 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
- Female sex;
- Age from 18 years old;
- Diagnosis of urgency urinary incontinence or mixed urinary incontinence
- Score greater than or equal to 8 on the Hyperactive Bladder - Validated 8 Question Awareness Tool (OAB-V8)
Who cannot join
- -Active urinary infection in the last four weeks;
- Alcoholism, smoking or drug addiction;
- Lesions and alteration of skin sensitivity in the place where electrotherapy will be applied;
- Drug and/or physiotherapeutic treatment for urgency urinary incontinence;
- Use of sleep-inducing medication,
- Any neurological disease (multiple sclerosis, Alzheimer's disease, stroke and Parkinson's disease);
Show all 10Show fewer
- Use of anticholinergic drugs, calcium antagonists, b-antagonists and dopamine antagonists;
- Presence of pelvic organ prolapse (POP), measured by a score greater than III by the POP-Q system;
- Any comprehension difficulty or cognitive deficit that makes it impossible to carry out the research;
- Gestational or puerperal period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de medicina integral fernando figueira
Recife, Pernambuco, 50070-902
About this study
Official title: Effect of Tibial Transcutaneous Electrostimulation in Women with Urgency Urinary Incontinence Compared to a Sham Group: Randomized Clinical Trial
Urge urinary incontinence (UUI) is associated with nocturia, a common cause of sleep disorders, also related to levels of anxiety and depression. Studies demonstrate improvement in the clinical parameters of women with UUI after treatment with transcutaneous tibial nerve stimulation (TTNS). However, there are few data available on the association of urinary symptoms in women with UUI with sedentary behavior (SB), physical activity level (PAL) and sleep quality (SQ). Our study has the objective of evaluating the impact of TTNS on urinary symptoms, anxiety level, life quality(LQ), sleep parameters, PAL and SB in women with UUI.
Read the detailed description
A randomized clinical trial, sham-controlled, comparing behavioral therapy and TTNS (intervention) to the use of behavioral therapy alone. It will include women with 18 years or more, diagnosed with UUI or mixed IU attested by the Questionnaire Overactive Bladder Validated 8 (OAB-V8).
Women with active urinary tract infection in the last four weeks, alcoholics, smokers or drug addicts, with lesions and alteration of skin sensitivity in the place where electrotherapy will be applied, in drug and/or physiotherapeutic treatment for UUI or current OAB, using sleep-inducing medication, with any neurological disease, using anticholinergic drugs, calcium antagonists, antagonists and dopamine antagonists, with presence of pelvic organ prolapse, during pregnancy or puerperal or with any difficulty in understanding or cognitive deficit that makes it impossible to carry out the research will be excluded.
Study variables are behavioral therapy, bilateral transcutaneous tibial nerve stimulation, type of UI, PAL, excessive daytime sleepiness, generic and specific LQ, SQ, UI severity, anxiety level, urinary frequency, nocturia and bladder capacity.
Sample size was calculated, adopting a two-tailed test with the following parameters: α = 0.05, β = 0.20 and statistical power of 80% and 102 women will be included.
The study will be carried out in two physiotherapy clinics in Recife, from September 2022 to June 2023, both groups will undergo a behavioral therapy protocol, (bladder training, pelvic floor muscle training and modification of liquid intake). Patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a electrical stimulation device (Quark, Brazil). The following parameters will be used for TTNS: frequency 10Hz (dez Hertz), pulse duration 200 μs (microseconds), for 30 minutes. In the experimental group, the electrodes will be positioned on the medial malleolus of both legs), in order to stimulate the tibial nerve path. In the Sham group, the electrodes will be placed on both legs, centered in the middle of the thigh, where there is no stimulus for the tibial or sacral nerve, for 30 minutes.
The project was approved by the Research Ethics Committee of Professor Fernando Figueira Institute of Integral Medicine.
- Conditions
- Urinary Incontinence, Urge
- Being tested
- TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION, behavioral therapy protocol
- Keywords
- urinary incontinence, Sleep, nocturia, sedentary behavior, anxiety, quality of life
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Incontinence, Nocturia, Sedentary Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIBIAL TRANSCUTANEOUS ELECTROSTIMULATIONDevice
The electrodes will be surface (silicone rubber and carbonate), brand Quark®, with dimensions of 5 cm by 3 cm, coupled with conductive gel and fixed to the volunteer's skin with micropore tape. For the placement of the electrodes, the volunteer will be positioned in the horizontal supine position on the stretcher, with the knee in semiflexion and the head supported on a pillow. The electrodes will be positioned one immediately posterior to the medial malleolus of the ankle and the other approximately 10 cm above it, both fixed with micropore tape, on both legs of the patient. To ensure that the electrodes stimulate the tibial nerve, a transcutaneous electrical nerve stimulation (TENS) current with a frequency of 1 Hz will first be applied, with a gradual increase in intensity, to verify a rhythmic movement of flexion of the hallux. The following parameters will be used for TTNS: frequency 10Hz (Hertz), pulse duration 200 μs (microseconds), for 30 minutes.
behavioral therapy protocolBehavioural
submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy | Experimental | EG (experimental group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. In addition, patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a DUALPEX 961s electrical stimulation device (Quark, Brazil). Receives: Device: TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION; Behavioral: behavioral therapy protocol |
| GS (Sham-sham group): Behavioral therapy | Sham comparator | GS (Sham-sham group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. Twelve sessions will be held, twice a week, on non-consecutive days. The electrodes of the DUALPEX 961 equipment will be positioned one immediately posterior to the lateral malleolus of the ankle and the other approximately 30 cm above it, where there is no stimulus for the tibial nerve. Receives: Behavioral: behavioral therapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturia
People with an overactive bladder can experience nocturia, which means they need to get up frequently at night to go to the bathroom. Nocturia will be evaluated through the voiding diary that the volunteers will be instructed to complete. The more times the volunteer gets up at night to urinate, the more severe the condition.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Secondary outcomes (12)
sleep quality
Assessed by the Pittsburgh Sleep Quality Index (PSQI), with the global score ranging from 0 to 21. The higher, the worse the sleep quality.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
physical activity level
lifestyle based on the daily number of steps
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
sedentary behavior
lifestyle based on the daily number of steps
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
anxiety level
A mental health disorder characterized by feelings of worry, anxiety, or fear that are strong enough to interfere with daily activities. Screening for study anxiety will be performed using the the Hospital Anxiety and Depression Scale (HADS). The scale is validated for Portuguese and was developed to identify possible cases of anxiety and depression through a structured and easy-to-apply questionnaire.The HADS consists of two subscales of 14 varied questions: 7 questions that measure anxiety (HADS-A) and 7 that measure depression (HADS-D). Each question has four possible answers and a score from 0 to 3 is given. The total score is then calculated and can range between 0 and 21 points on each subscale, with a higher score indicating more severe symptoms. The cut-off score for "possible cases" of anxiety and depression is 8 points or higher, which is the cut-off identified to provide the optimal balance between specificity and sensitivity.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Total time of sleep
Total time the individual spent sleeping during the night
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Excessive daytime sleepiness
discrete quantitative variable, assessed using the Epworth sleepiness scale 1 ( ) yes, 2 ( ) no. It is a self-administered questionnaire and refers to the possibility of napping in eight everyday situations.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Severity of urinary incontinence
To identify how much the urinary incontinence impacts one's life.The severity of UI will be assessed using the Incontinence Severity Index (ISI), translated and validated into Portuguese by Pereira et al, in 2011 (Appendix 1)(126). This instrument consists of two questions regarding the frequency (1-4 points) and amount (1-3 points) of urinary loss. To obtain the final score, the scores for frequency of urinary leakage and the amount of urinary leakage are multiplied.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Life's quality
The SF-36 Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36) is a generic instrument for assessing quality of life that is easy to administer and understand. It consists of a multidimensional questionnaire, consisting of 36 items, encompassed in 8 scales or domains. It has a final score from 0 to 100 (obtained by calculating the Raw Scale), where 0 corresponds to the worst general health status and 100 corresponds to the best health status.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - sleep efficiency
Sleep efficiency is the relationship between the time the patient spent in bed and the actual sleep time.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Total time in bed
Total time in bed, whether sleeping or not.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Nightly awakenings
Number of times the individual wakes up during the night
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Time awake after falling asleep
Time awake after sleep started, total time of nocturnal awakenings.
Measured: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start23 Jan 2023
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Incontinence, UrgeStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
- Investigators
- Leila Katz, PHD, Principal investigator, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590481
- Sponsor's protocol ID
- TIBIALTENS
- Acronym
- TibialTNS
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tibial Transcutaneous Electrostimulation in Women with Urgency Urinary Incontinence Compared to a Sham Group: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05590481
- Acronym / sponsor ID
- TibialTNS / TIBIALTENS
- Conditions
- Urinary Incontinence, Urge
- Keywords
- urinary incontinence, Sleep, nocturia, sedentary behavior, anxiety, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 21 Oct 2022 (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.
Urge urinary incontinence (UUI) is associated with nocturia, a common cause of sleep disorders, also related to levels of anxiety and depression. Studies demonstrate improvement in the clinical parameters of women with UUI after treatment with transcutaneous tibial nerve stimulation (TTNS). However, there are few data available on the association of urinary symptoms in women with UUI with sedentary behavior (SB), physical activity level (PAL) and sleep quality (SQ). Our study has the objective of evaluating the impact of TTNS on urinary symptoms, anxiety level, life quality(LQ), sleep parameters, PAL and SB in women with UUI.
Detailed description
A randomized clinical trial, sham-controlled, comparing behavioral therapy and TTNS (intervention) to the use of behavioral therapy alone. It will include women with 18 years or more, diagnosed with UUI or mixed IU attested by the Questionnaire Overactive Bladder Validated 8 (OAB-V8).
Women with active urinary tract infection in the last four weeks, alcoholics, smokers or drug addicts, with lesions and alteration of skin sensitivity in the place where electrotherapy will be applied, in drug and/or physiotherapeutic treatment for UUI or current OAB, using sleep-inducing medication, with any neurological disease, using anticholinergic drugs, calcium antagonists, antagonists and dopamine antagonists, with presence of pelvic organ prolapse, during pregnancy or puerperal or with any difficulty in understanding or cognitive deficit that makes it impossible to carry out the research will be excluded.
Study variables are behavioral therapy, bilateral transcutaneous tibial nerve stimulation, type of UI, PAL, excessive daytime sleepiness, generic and specific LQ, SQ, UI severity, anxiety level, urinary frequency, nocturia and bladder capacity.
Sample size was calculated, adopting a two-tailed test with the following parameters: α = 0.05, β = 0.20 and statistical power of 80% and 102 women will be included.
The study will be carried out in two physiotherapy clinics in Recife, from September 2022 to June 2023, both groups will undergo a behavioral therapy protocol, (bladder training, pelvic floor muscle training and modification of liquid intake). Patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a electrical stimulation device (Quark, Brazil). The following parameters will be used for TTNS: frequency 10Hz (dez Hertz), pulse duration 200 μs (microseconds), for 30 minutes. In the experimental group, the electrodes will be positioned on the medial malleolus of both legs), in order to stimulate the tibial nerve path. In the Sham group, the electrodes will be placed on both legs, centered in the middle of the thigh, where there is no stimulus for the tibial or sacral nerve, for 30 minutes.
The project was approved by the Research Ethics Committee of Professor Fernando Figueira Institute of Integral Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy | Experimental | Device: TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION, Behavioral: behavioral therapy protocolEG (experimental group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. In addition, patients will be submitted to biphasic current and surface electrodes during 12 treatment sessions, twice a week, on non-consecutive days, with a DUALPEX 961s electrical stimulation device (Quark, Brazil). |
| GS (Sham-sham group): Behavioral therapy | Sham comparator | Behavioral: behavioral therapy protocolGS (Sham-sham group): submitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. Twelve sessions will be held, twice a week, on non-consecutive days. The electrodes of the DUALPEX 961 equipment will be positioned one immediately posterior to the lateral malleolus of the ankle and the other approximately 30 cm above it, where there is no stimulus for the tibial nerve. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female sex;
- Age from 18 years old;
- Diagnosis of urgency urinary incontinence or mixed urinary incontinence
- Score greater than or equal to 8 on the Hyperactive Bladder - Validated 8 Question Awareness Tool (OAB-V8)
Key exclusion criteria (10 listed)
- -Active urinary infection in the last four weeks;
- Alcoholism, smoking or drug addiction;
- Lesions and alteration of skin sensitivity in the place where electrotherapy will be applied;
- Drug and/or physiotherapeutic treatment for urgency urinary incontinence;
- Use of sleep-inducing medication,
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 |
|---|---|---|
| TIBIAL TRANSCUTANEOUS ELECTROSTIMULATIONThe electrodes will be surface (silicone rubber and carbonate), brand Quark®, with dimensions of 5 cm by 3 cm, coupled with conductive gel and fixed to the volunteer's skin with micropore tape. For the placement of the electrodes, the volunteer will be positioned in the horizontal supine position on the stretcher, with the knee in semiflexion and the head supported on a pillow. The electrodes will be positioned one immediately posterior to the medial malleolus of the ankle and the other approximately 10 cm above it, both fixed with micropore tape, on both legs of the patient. To ensure that the electrodes stimulate the tibial nerve, a transcutaneous electrical nerve stimulation (TENS) current with a frequency of 1 Hz will first be applied, with a gradual increase in intensity, to verify a rhythmic movement of flexion of the hallux. The following parameters will be used for TTNS: frequency 10Hz (Hertz), pulse duration 200 μs (microseconds), for 30 minutes. | Device | EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy |
| behavioral therapy protocolsubmitted to a behavioral therapy protocol, which involves bladder training, pelvic floor muscle training and modification of liquid intake. The orientation will be based on the initial evaluation of the patient, in which the responsible researcher will give verbal orientations and deliver booklets on the pathology, behavioral therapy and sleep hygiene. | Behavioural | EG (experimental group): TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION + Behavioral Therapy, GS (Sham-sham group): Behavioral therapy |
Primary outcome
Nocturia
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
People with an overactive bladder can experience nocturia, which means they need to get up frequently at night to go to the bathroom. Nocturia will be evaluated through the voiding diary that the volunteers will be instructed to complete. The more times the volunteer gets up at night to urinate, the more severe the condition.
12 secondary outcomes
sleep quality
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
physical activity level
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
sedentary behavior
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
anxiety level
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Total time of sleep
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Excessive daytime sleepiness
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Severity of urinary incontinence
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Life's quality
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - sleep efficiency
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Total time in bed
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Nightly awakenings
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
Sleep parameters - Time awake after falling asleep
Time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).
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 19 Sep 2024.
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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.
Leila Katz, PHD principal investigator
Instituto Materno Infantil Prof. Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIBIAL TRANSCUTANEOUS ELECTROSTIMULATION and behavioral therapy protocol in people with Urinary Incontinence, Urge, run by Instituto Materno Infantil Prof. Fernando Figueira 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 4 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 19 Sep 2024. 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?
Nocturia (time frame: Baseline/ change after the 6th week of treatment /change 30 days after the 6th week of treatment(follow up).). 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 19 Sep 2024.