Overactive BladderNCT03742206
Comparison of Two Forms of Transcutaneous Electrical Stimulation in Overactive Bladder
A study testing Parasacral Transcutaneous Electrical Stimulation and Transcutaneous Posterior Tibial Nerve Stimulation in people with Overactive Bladder and Urinary Urge Incontinence, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder, Urinary Urge Incontinence
- What is being tested?
- Parasacral Transcutaneous Electrical Stimulation and Transcutaneous Posterior Tibial Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteBrazil
- Study dates
- 25 Jan 2018to Oct 2019
- 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
- Diagnosis of overactive bladder with or without the presence of urinary incontinence.
- Understand the instruments used in the research.
Who cannot join
- Urinary tract infection
- Neurological disease
- Other previous treatment in the last four weeks
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Suzana Mallmann
Porto Alegre, Rio Grande do Sul
Mallmann, +5551996261820, suzana_mallmann@hotmail.com
José Geraldo Lopes Ramos
About this study
Official title: Comparison of Parasacral Transcutaneous Electrical Stimulation With Transcutaneous Posterior Tibial Nerve Stimulation in Women With Overactive Bladder: a Randomized Clinical Trial
Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women.
Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.
Read the detailed description
Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed
Main outcome: to measure changes in urinary urgency and quality of life.
Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.
- Conditions
- Overactive Bladder, Urinary Urge Incontinence
- Being tested
- Parasacral Transcutaneous Electrical Stimulation, Transcutaneous Posterior Tibial Nerve Stimulation
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasacral Transcutaneous Electrical StimulationDevice
Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.
Transcutaneous Posterior Tibial Nerve StimulationDevice
Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation
| Study group | Role | What they receive |
|---|---|---|
| Parasacral | Experimental | Parasacral Transcutaneous Electrical Stimulation Group: participants in this group will receive two self-adhesive electrodes and will be instructed to position them in the sacral region. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks. Receives: Device: Parasacral Transcutaneous Electrical Stimulation |
| Posterior Tibial Nerve | Active comparator | Transcutaneous Posterior Tibial Nerve Stimulation Group: participants in this group will receive a neoprene ankle brace that will be connected to the electrostimulator. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks. Receives: Device: Transcutaneous Posterior Tibial Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment in quality of life
Application of the King's Health Questionnaire (KHQ). KHQ is an instrument for measuring quality of life in people diagnosed with urinary incontinence, consisting of 30 objective questions distributed in 9 domains. In each question, values are assigned according to the intensity of the patient's complaint (0 = not applicable, 1 = no; 2 = a little / sometimes, 3 = more or less / several times, 4 = a lot / always). The final score is calculated individually for each domain and ranges from 0 to 100, the highest score being related to a poorer quality of life.
Measured: six weeks
Secondary outcomes (2)
Severity of urinary incontinence
Application of the Incontinence Severity Index. It is a brief instrument, consisting of two questions regarding the frequency and amount of urinary loss. The final score obtained by multiplying the frequency scores by the amount of urinary loss allows the incontinence urinary to be classified as mild (final score 1-2), moderate (final score 3-6 ), severe (final score 8-9) and very severe (final score 12).
Measured: six weeks
Severity of overactive bladder symptoms
Application of the Symptom Bother Scale. It instrument asks how bothered the patient is by the 4 hallmark symptoms of overactive bladder: urinary frequency, urgency, nocturia, and urge incontinence. Patients respond on a 6-point Likert scale ranging from 0 (not at all) to 5 (a very great deal), with a maximum possible score of 40, calculated by adding all responses.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start25 Jan 2018
- Primary completionOct 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José Geraldo Lopes Ramos, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742206
- Sponsor's protocol ID
- 17-0056
- Status last verified
- Oct 2018
- First submitted
- 31 Oct 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Parasacral Transcutaneous Electrical Stimulation With Transcutaneous Posterior Tibial Nerve Stimulation in Women With Overactive Bladder: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03742206
- Acronym / sponsor ID
- 17-0056
- Conditions
- Overactive Bladder, Urinary Urge Incontinence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 15 Nov 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.
Aim: To compare the effects of parasacral transcutaneous electrical stimulation with transcutaneous posterior tibial nerve stimulation on the symptoms of Overactive Bladder in women.
Study's hypothesis: The use of the parasacral transcutaneous electrical stimulation technique presents better results regarding the remission of overactive bladder symptoms in relation to transcutaneous posterior tibial nerve stimulation.
Detailed description
Search location: The data will collected at the Ambulatory of Urogynecology and Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic Physiotherapy are performed
Main outcome: to measure changes in urinary urgency and quality of life.
Secondary outcome: to measure changes in the severity of urinary incontinence and the symptom bother.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parasacral | Experimental | Device: Parasacral Transcutaneous Electrical StimulationParasacral Transcutaneous Electrical Stimulation Group: participants in this group will receive two self-adhesive electrodes and will be instructed to position them in the sacral region. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks. |
| Posterior Tibial Nerve | Active comparator | Device: Transcutaneous Posterior Tibial Nerve StimulationTranscutaneous Posterior Tibial Nerve Stimulation Group: participants in this group will receive a neoprene ankle brace that will be connected to the electrostimulator. Current parameters will be: 10 hertz frequency, 700μs wavelength, 20 minute therapy duration, 3x frequency in the week. The treatment will be at home for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of overactive bladder with or without the presence of urinary incontinence.
- Understand the instruments used in the research.
Key exclusion criteria (3 listed)
- Urinary tract infection
- Neurological disease
- Other previous treatment in the last four weeks
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 |
|---|---|---|
| Parasacral Transcutaneous Electrical StimulationElectrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation. | Device | Parasacral |
| Transcutaneous Posterior Tibial Nerve StimulationElectrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation | Device | Posterior Tibial Nerve |
Primary outcome
Efficacy of treatment in quality of life
Time frame: six weeks
Application of the King's Health Questionnaire (KHQ). KHQ is an instrument for measuring quality of life in people diagnosed with urinary incontinence, consisting of 30 objective questions distributed in 9 domains. In each question, values are assigned according to the intensity of the patient's complaint (0 = not applicable, 1 = no; 2 = a little / sometimes, 3 = more or less / several times, 4 = a lot / always). The final score is calculated individually for each domain and ranges from 0 to 100, the highest score being related to a poorer quality of life.
2 secondary outcomes
Severity of urinary incontinence
Time frame: six weeks
Severity of overactive bladder symptoms
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
José Geraldo Lopes Ramos principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasacral Transcutaneous Electrical Stimulation and Transcutaneous Posterior Tibial Nerve Stimulation in people with Overactive Bladder and Urinary Urge Incontinence, run by Hospital de Clinicas de Porto Alegre 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 2 inclusion and 3 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 15 Nov 2018. 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 Mallmann (+5551996261820, suzana_mallmann@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of treatment in quality of life (time frame: six weeks). 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 15 Nov 2018.