Overactive Bladder SyndromeOABNCT03250650
Physiotherapy in Overactive Bladder: Electrical Stimulation Treatment
A study testing TTNS and ES+TTNS in people with Overactive Bladder Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female overactive bladder syndrome (OAB). 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?
- TTNS and ES+TTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteBrazil
- Study dates
- 9 Mar 2017to 30 Jun 2018
- 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 diagnosed with Overactive Bladder Syndrom no neurogenic or Mixed Incontinence Urinary with overactive bladder´s predominance symptoms more than 6 months.
- Over 18 years old.
- Normal cognitive level to understand the orientations during the treatment.
Who cannot join
- Stress Urinary Incontinence
- Drugs treatment for overactive bladder
- Pregnant women
- Neurologic diseases
- Urinary infecction
- Cystocele, rectocele and uterine prolapse
Show all 11Show fewer
- Infectious contagious diseases
- Metal implants on the hip or lower members
- Cardiac pacemaker
- Bladder tumor
- Vaginal infecction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial
To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female overactive bladder syndrome (OAB).
Read the detailed description
This is a clinical trial, blind and randomized study with 86 women with OAB or Mixed Urinary Incontinence with prevalence in the OAB symptoms, who were randomly and allocated into 2 equal groups. Group 1 underwent transcutaneous tibial nerve electrical stimulation (TTNS),for 30 minutes using 10Hz for frequency and 200µs for pulse. Group 2 received a combined of Vaginal electrical stimulation (ES) using a transvaginal probe applied ,for 20 minutes using 10Hz for frequency and 1ms for pulse and tibial nerve electrical stimulation, 30 minutes at the same parameters used in Group1. Both groups were treated once a week for 12 sessions. All patients were evaluated before and after treatment by a voiding diary, King´s Health questionnaire, avaliation of pelvic floor muscle function, overactive bladder questionnaire (OABV-8).The analyzed variables included day and night time frequency, urgency and urge incontinence.
The sample calculation was based on the difference waited between 2 groups regarding the frequency improvment.
- Conditions
- Overactive Bladder Syndrome
- Being tested
- TTNS, ES+TTNS
- Keywords
- Overactive Bladder, Electric Stimulation, Physical Therapy Modalities
- 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.
TTNSDevice
Transcutaneous tibial electric stimulation
ES+TTNSDevice
Transvaginal electric stimulation
| Study group | Role | What they receive |
|---|---|---|
| Group 1: TTNS | Active comparator | Intervention for Group 1: transcutaneous tibial nerve electric stimulation (TTNS), using a Device Dualpex 961(Quark medical), with 2 silicone electrode in the tibial nerve path, being one on the lower border of the medial malleolus and another one, 10cm above. Once a week for 12 weeks. The parameters used on device were, 200 microseconds for pulse time and 10Hz for Frequency, during 30 minutes. Receives: Device: TTNS |
| Group 2: ES + TTNS | Experimental | Intervention for Group 2: transvaginal electric stimulation plus transcutaneous tibial nerve electric stimulation (ES + TTNS), using a Device Dualpex 961(Quark medical), with transvaginal electrode, located inside the vagina. Once a week for 12 weeks. The parameters used on device were 1milisecond for pulse time and 10Hz for Frequency, during 20 minutes. After transvaginal stimulation, the tibial stimulation will be applied like described on Group 1. Receives: Device: ES+TTNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreasing the numbers of urinary frequency during day and night
We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.
Measured: 1 month
Secondary outcomes (1)
Improvement of miccional urgency and urinary urgency incontinence
We expect that patients will get better decreasing symptoms of urinary urgency and urinary incontinence urgency consequently.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start9 Mar 2017
- Primary completion30 Apr 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive Bladder SyndromeStudies 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
- Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Alves Gonçalves Ferreira, University of Sao Paulo General Hospital
- Investigators
- Elizabeth A Ferreira, PhD, Principal investigator, University of Sao PauloFernanda B Giarreta, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250650
- Sponsor's protocol ID
- 63041516.7.0000.0068
- Acronym
- OAB
- Status last verified
- Apr 2019
- First submitted
- 13 Jul 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Tibial Nerve Electrical Stimulation Combined With Transvaginal Electrical Stimulation in Overactive Bladder Syndrome Treatment: Clinical Trial
- ClinicalTrials.gov ID
- NCT03250650
- Acronym / sponsor ID
- OAB / 63041516.7.0000.0068
- Conditions
- Overactive Bladder Syndrome
- Keywords
- Overactive Bladder, Electric Stimulation, Physical Therapy Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 16 Aug 2017 (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.
To evaluate the efficacy of combined transvaginal electrical stimulation (ES) and transcutaneous tibial nerve electrical stimulation (TTNS) in the treatment of female overactive bladder syndrome (OAB).
Detailed description
This is a clinical trial, blind and randomized study with 86 women with OAB or Mixed Urinary Incontinence with prevalence in the OAB symptoms, who were randomly and allocated into 2 equal groups. Group 1 underwent transcutaneous tibial nerve electrical stimulation (TTNS),for 30 minutes using 10Hz for frequency and 200µs for pulse. Group 2 received a combined of Vaginal electrical stimulation (ES) using a transvaginal probe applied ,for 20 minutes using 10Hz for frequency and 1ms for pulse and tibial nerve electrical stimulation, 30 minutes at the same parameters used in Group1. Both groups were treated once a week for 12 sessions. All patients were evaluated before and after treatment by a voiding diary, King´s Health questionnaire, avaliation of pelvic floor muscle function, overactive bladder questionnaire (OABV-8).The analyzed variables included day and night time frequency, urgency and urge incontinence.
The sample calculation was based on the difference waited between 2 groups regarding the frequency improvment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: will be treated receiving Transcutaneous Tibial Electric Stimulation Group 2: will be treated receiving TTNS and Transvaginal Electric Stimulation
| Arm | Type | Receives |
|---|---|---|
| Group 1: TTNS | Active comparator | Device: TTNSIntervention for Group 1: transcutaneous tibial nerve electric stimulation (TTNS), using a Device Dualpex 961(Quark medical), with 2 silicone electrode in the tibial nerve path, being one on the lower border of the medial malleolus and another one, 10cm above. Once a week for 12 weeks. The parameters used on device were, 200 microseconds for pulse time and 10Hz for Frequency, during 30 minutes. |
| Group 2: ES + TTNS | Experimental | Device: ES+TTNSIntervention for Group 2: transvaginal electric stimulation plus transcutaneous tibial nerve electric stimulation (ES + TTNS), using a Device Dualpex 961(Quark medical), with transvaginal electrode, located inside the vagina. Once a week for 12 weeks. The parameters used on device were 1milisecond for pulse time and 10Hz for Frequency, during 20 minutes. After transvaginal stimulation, the tibial stimulation will be applied like described on Group 1. |
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 diagnosed with Overactive Bladder Syndrom no neurogenic or Mixed Incontinence Urinary with overactive bladder´s predominance symptoms more than 6 months.
- Over 18 years old.
- Normal cognitive level to understand the orientations during the treatment.
Key exclusion criteria (11 listed)
- Stress Urinary Incontinence
- Drugs treatment for overactive bladder
- Pregnant women
- Neurologic diseases
- Urinary infecction
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 |
|---|---|---|
| TTNSTranscutaneous tibial electric stimulation | Device | Group 1: TTNS |
| ES+TTNSTransvaginal electric stimulation | Device | Group 2: ES + TTNS |
Primary outcome
Decreasing the numbers of urinary frequency during day and night
Time frame: 1 month
We expect that patiens will decrease the void´s number during day (under 8), and during night, recovering theirs life´s quality.
1 secondary outcome
Improvement of miccional urgency and urinary urgency incontinence
Time frame: 2 months
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 17 Apr 2019.
- Individual participant dataSharing planned: No. There is no plan to share participant data with other researchers.
Related trials for Overactive Bladder Syndrome
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Efficacy and Safety of Peroneal Electric Transcutaneous Neuromodulation in the Real-world Clinical Practice
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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 A Ferreira, PhD principal investigator
University of Sao Paulo
Fernanda B Giarreta study chair
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTNS and ES+TTNS 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 11 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 17 Apr 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. 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?
Decreasing the numbers of urinary frequency during day and night (time frame: 1 month). 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 17 Apr 2019; AzTrials last refreshed its copy on 27 Oct 2026.