Urge IncontinenceNCT02452593
Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder
A study testing "Tibial stimulation" and "pelvic floor exercises" in people with Urge Incontinence, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial summary
Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women's lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urge Incontinence
- What is being tested?
- "Tibial stimulation" and "pelvic floor exercises"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Aug 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women with Urinary Incontinence of Urgency or Mixed older than 18 years
Who cannot join
- Presence Of vaginal or urinary infection
- Not understand or sign the informed consent
- Not understand or are unable to perform the proposed treatment
- Pregnancy or the postpartum period covering the period up to 6 months after delivery
- Women in previous use of chronically used drugs (antidepressants, diuretics, and others) that can evidently alter the urinary function.
- Stress Urinary Incontinence of pure or mixed incontinence with a predominance of Stress component neurogenic bladder
Show all 15Show fewer
- Use of Botox® in the bladder or pelvic muscles in the last year
- Use Interstim® or Bion®
- Use pacemaker or implantable defibrillator
- Current use of TENS in the pelvic region, lower back or legs
- Previous use of percutaneous tibial stimulation
- Drug / experimental devices in the past 4 weeks,
- Participation in any clinical research involving or affecting the urinary or renal function in the last 4 weeks.
- Pelvic radiotherapy;
- Changes in sensibility Lower Limb;
Trial locations and contacts
1 site in 1 country.
Magda Ms Aranchipe, Master contact
Luciana Dr Paiva, PhD contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Magda Aranchipe, mchipe@hotmail.com
About this study
Official title: Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder, Urge and Mixed Urinary Incontinence
Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women's lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency.
The overactive bladder present in urge incontinence and mixed cause significant impacts on people's lives and has a prevalence of 16.5% in the US population.
Read more
Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment. Drug therapy using drugs which are not specific for the bladder and are associated with many unwanted systemic side effects.
The results obtained by researchers in several countries using conservative techniques in the treatment of patients with urinary incontinence are encouraging and this study aims to evaluate carefully and systematically the effectiveness of tibial stimulation technique.
Importantly, also, that conservative techniques have lower cost than the surgical treatment and have virtually no side effects as most of the drugs used in the pharmacological treatment of female urinary incontinence.
Read the detailed description
Goal
Development of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using tibial stimulation and pelvic floor exercises.
Secondary objectives
- Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point).
- Comparison of the effectiveness of tibial stimulation techniques and pelvic floor exercises in the treatment of overactive bladder and urgency / mixed incontinence.
Design Randomized Clinical Trial
Sample Women over the age of 18, complaining of urinary incontinence Urgency or Mixed (with main urgency component), catered in Urogynecology Ambulatory of Hospital de Clinicas de Porto Alegre.
- Conditions
- Urge Incontinence
- Being tested
- "Tibial stimulation" and "pelvic floor exercises"
- Keywords
- incontinence; pelvic floor exercises; neuromodulation
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Tibial stimulation" and "pelvic floor exercises"Other
A group will make tibial nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| "Tibial Nerve Stimulation" | Active comparator | This group will do transcutaneous electrical stimulation of the tibial nerve at home.
Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point). Frequency: 20 Hz, Pulse width: 200 us; duration: 15min daily Receives: Other: "Tibial stimulation" and "pelvic floor exercises" |
| "Pelvic Floor Exercises" | Active comparator | This group will make pelvic muscle training 3 times a day . In decubit dorsal posture, legs flexed and abductee. Perform pelvic floor contractions keeping 2 seconds and relaxing 4 seconds for 10 times, and contractions keeping 4 seconds and relaxing 8 seconds for 10 times. Receives: Other: "Tibial stimulation" and "pelvic floor exercises" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Urinary incontinence
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 May 2015 (estimated)
- Study startJan 2014
- Primary completionJul 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge IncontinenceStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Responsible party
- Principal investigator, Magda da Silva Aranchipe, Federal University of Rio Grande do Sul
- Investigators
- Jose Geraldo Dr Ramos, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452593
- Sponsor's protocol ID
- UFRGSDGO
- Status last verified
- May 2015
- First submitted
- 8 Apr 2015
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder, Urge and Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02452593
- Acronym / sponsor ID
- UFRGSDGO
- Conditions
- Urge Incontinence
- Keywords
- incontinence; pelvic floor exercises; neuromodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Collaborators
- Hospital de Clinicas de Porto Alegre
- Study start
- Jan 2014
- Primary completion
- Jul 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 22 May 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.
Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women's lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency.
The overactive bladder present in urge incontinence and mixed cause significant impacts on people's lives and has a prevalence of 16.5% in the US population.
Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment. Drug therapy using drugs which are not specific for the bladder and are associated with many unwanted systemic side effects.
The results obtained by researchers in several countries using conservative techniques in the treatment of patients with urinary incontinence are encouraging and this study aims to evaluate carefully and systematically the effectiveness of tibial stimulation technique.
Importantly, also, that conservative techniques have lower cost than the surgical treatment and have virtually no side effects as most of the drugs used in the pharmacological treatment of female urinary incontinence.
Detailed description
Goal
Development of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using tibial stimulation and pelvic floor exercises.
Secondary objectives
- Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point).
- Comparison of the effectiveness of tibial stimulation techniques and pelvic floor exercises in the treatment of overactive bladder and urgency / mixed incontinence.
Design Randomized Clinical Trial
Sample Women over the age of 18, complaining of urinary incontinence Urgency or Mixed (with main urgency component), catered in Urogynecology Ambulatory of Hospital de Clinicas de Porto Alegre.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Tibial Nerve Stimulation" | Active comparator | Other: "Tibial stimulation" and "pelvic floor exercises"This group will do transcutaneous electrical stimulation of the tibial nerve at home. Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point). Frequency: 20 Hz, Pulse width: 200 us; duration: 15min daily |
| "Pelvic Floor Exercises" | Active comparator | Other: "Tibial stimulation" and "pelvic floor exercises"This group will make pelvic muscle training 3 times a day . In decubit dorsal posture, legs flexed and abductee. Perform pelvic floor contractions keeping 2 seconds and relaxing 4 seconds for 10 times, and contractions keeping 4 seconds and relaxing 8 seconds for 10 times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women with Urinary Incontinence of Urgency or Mixed older than 18 years
Key exclusion criteria (15 listed)
- Presence Of vaginal or urinary infection
- Not understand or sign the informed consent
- Not understand or are unable to perform the proposed treatment
- Pregnancy or the postpartum period covering the period up to 6 months after delivery
- Women in previous use of chronically used drugs (antidepressants, diuretics, and others) that can evidently alter the urinary function.
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 stimulation" and "pelvic floor exercises"A group will make tibial nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks | Other | "Pelvic Floor Exercises", "Tibial Nerve Stimulation" |
Primary outcome
Number of participants with Urinary incontinence
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 May 2015.
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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.
Magda Ms Aranchipe, Master contact
Luciana Dr Paiva, PhD contact
Jose Geraldo Dr Ramos, PhD 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 study testing "Tibial stimulation" and "pelvic floor exercises" in people with Urge Incontinence, run by Federal University of Rio Grande do Sul 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 1 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: status not confirmed, as of the sponsor's last update on 22 May 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magda Ms Aranchipe, Master (mchipe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Urinary incontinence (time frame: 3 months). 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 22 May 2015.