HTLV-1Phase 4NCT06616675
Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1
A Phase 4 study testing Darifenacin and Neuromodulation - Sacral nerve stimulation in people with HTLV-1 and Overactive Bladder Syndrome, run by Hospital Universitário Professor Edgard Santos at 1 site in Brazil.
Trial summary
In this study the investigators compare the parasacral transcutaneous electric nerve stimulation (PTENS) treatment with Darifenacin to improve OAB symptoms in patients infected with HTLV-1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HTLV-1, Overactive Bladder Syndrome
- What is being tested?
- Darifenacin and Neuromodulation - Sacral nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Mar 2022to 20 Dec 2023
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HTLV-1 infection
- Overactive bladder symptom
- 18 years of age or older
Who cannot join
- HTLV-1 infected subjects with HAM
- Stroke
- Parkinson
- HIV infection
- Prostatic hyperplasia
- Pacemaker use
- Genitourinary tract infection
- Glaucoma
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ambulatório de HTLV-1 - Com HUPES
Salvador, Estado de Bahia, 40110060
About this study
Official title: Darifenacin Versus Parasacral Transcutaneous Electric Nerve Stimulation for Overactive Bladder Syndrome in Patients Infected With Human T-Lymphotropic Virus 1 - Randomized Open Clinical Trial
In this study the investigators compare the parasacral transcutaneous electric nerve stimulation (PTENS) treatment with Darifenacin to improve OAB symptoms in patients infected with HTLV-1.
Read the detailed description
Subjects presenting OAB according to ICS, associated with the HTLV-1 infection were invited by the investigators to participate in the study according inclusion criteria . Participants who accepted were randomly allocated to two groups (G1 and G2) by the free randomization website. Group 1 was treated with Darifenacin, and group 2 with the PTENS protocol.
Drug Treatment Protocol:
The anticholinergic Fenazic (Adium) was used in a single dose of 15mg/day for 2 months.
PTENS Protocol:
The treatment consisted of PTENS with the Neurodyn Portable TENS FES(21) neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions.
- Conditions
- HTLV-1, Overactive Bladder Syndrome
- Being tested
- Darifenacin, Neuromodulation - Sacral nerve stimulation
- Keywords
- Electrical stimulation, Overactive bladder, HLTV-1, darifenacin
- 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.
DarifenacinDrug
Anticholinergic drug therapy for OAB treatment - Darifenacin, 15mg/day
Neuromodulation - Sacral nerve stimulationDevice
Neurodyn Portable TENS FES neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Darifenacin Group | Active comparator | Anticholinergic treatment for OAB Receives: Drug: Darifenacin |
| PTENS Group | Experimental | Neuromodulation using transcutaneous electrical sacral nerves stimulation Receives: Device: Neuromodulation - Sacral nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overactive Bladder Symptom Score
Whether higher scores mean worse outcome
Measured: 2 months or 20 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start16 Mar 2022
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HTLV-1Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitário Professor Edgard Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tatiane Souza Soares de Oliveira, Hospital Universitário Professor Edgard Santos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616675
- Sponsor's protocol ID
- CAAE: 59171022.9.0000.0049
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, Xu G, Geng J. Efficacy of Transcutaneous Electrical Nerve Stimulation in the Management of Neurogenic Overactive Bladder: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):2-10. doi: 10.1097/PHM.0000000000001836.
PubMed 34225282Slovak M, Chapple CR, Barker AT. Non-invasive transcutaneous electrical stimulation in the treatment of overactive bladder. Asian J Urol. 2015 Apr;2(2):92-101. doi: 10.1016/j.ajur.2015.04.013. Epub 2015 Apr 16.
PubMed 29264126Andrade RC, Neto JA, Andrade L, Oliveira TS, Santos DN, Oliveira CJ, Prado MJ, Carvalho EM. Effects of Physiotherapy in the Treatment of Neurogenic Bladder in Patients Infected With Human T-Lymphotropic Virus 1. Urology. 2016 Mar;89:33-8. doi: 10.1016/j.urology.2015.09.036. Epub 2015 Dec 24.
PubMed 26724409
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Darifenacin Versus Parasacral Transcutaneous Electric Nerve Stimulation for Overactive Bladder Syndrome in Patients Infected With Human T-Lymphotropic Virus 1 - Randomized Open Clinical Trial
- ClinicalTrials.gov ID
- NCT06616675
- Acronym / sponsor ID
- CAAE: 59171022.9.0000.0049
- Conditions
- HTLV-1, Overactive Bladder Syndrome
- Keywords
- Electrical stimulation, Overactive bladder, HLTV-1, darifenacin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hospital Universitário Professor Edgard SantosUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 27 Sep 2024 (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.
In this study the investigators compare the parasacral transcutaneous electric nerve stimulation (PTENS) treatment with Darifenacin to improve OAB symptoms in patients infected with HTLV-1.
Detailed description
Subjects presenting OAB according to ICS, associated with the HTLV-1 infection were invited by the investigators to participate in the study according inclusion criteria . Participants who accepted were randomly allocated to two groups (G1 and G2) by the free randomization website. Group 1 was treated with Darifenacin, and group 2 with the PTENS protocol.
Drug Treatment Protocol:
The anticholinergic Fenazic (Adium) was used in a single dose of 15mg/day for 2 months.
PTENS Protocol:
The treatment consisted of PTENS with the Neurodyn Portable TENS FES(21) neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Darifenacin Group | Active comparator | Drug: DarifenacinAnticholinergic treatment for OAB |
| PTENS Group | Experimental | Device: Neuromodulation - Sacral nerve stimulationNeuromodulation using transcutaneous electrical sacral nerves stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- HTLV-1 infection
- Overactive bladder symptom
- 18 years of age or older
Key exclusion criteria (8 listed)
- HTLV-1 infected subjects with HAM
- Stroke
- Parkinson
- HIV infection
- Prostatic hyperplasia
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 |
|---|---|---|
| DarifenacinAnticholinergic drug therapy for OAB treatment - Darifenacin, 15mg/day | Drug | Darifenacin Group |
| Neuromodulation - Sacral nerve stimulationNeurodyn Portable TENS FES neuromuscular stimulation device in an outpatient clinic. Two self-adhesive electrodes (5x9cm) were used, positioned one in each gluteal region, below the iliac spine to apply low-frequency biphasic current with 10 Hz. Pulse duration of 0.5 milliseconds was applied for 40 minutes with continuous stimulation, 3 times a week, for 20 sessions. | Device | PTENS Group |
Primary outcome
Overactive Bladder Symptom Score
Time frame: 2 months or 20 sessions
Whether higher scores mean worse outcome
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 1 Oct 2024.
- Results publication: PubMed 34225282Liu Y, Xu G, Geng J. Efficacy of Transcutaneous Electrical Nerve Stimulation in the Management of Neurogenic Overactive Bladder: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):2-10. doi: 10.1097/PHM.0000000000001836.
- Results publication: PubMed 29264126Slovak M, Chapple CR, Barker AT. Non-invasive transcutaneous electrical stimulation in the treatment of overactive bladder. Asian J Urol. 2015 Apr;2(2):92-101. doi: 10.1016/j.ajur.2015.04.013. Epub 2015 Apr 16.
- Results publication: PubMed 26724409Andrade RC, Neto JA, Andrade L, Oliveira TS, Santos DN, Oliveira CJ, Prado MJ, Carvalho EM. Effects of Physiotherapy in the Treatment of Neurogenic Bladder in Patients Infected With Human T-Lymphotropic Virus 1. Urology. 2016 Mar;89:33-8. doi: 10.1016/j.urology.2015.09.036. Epub 2015 Dec 24.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Darifenacin and Neuromodulation - Sacral nerve stimulation in people with HTLV-1 and Overactive Bladder Syndrome, run by Hospital Universitário Professor Edgard Santos 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 8 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 1 Oct 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Overactive Bladder Symptom Score (time frame: 2 months or 20 sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06616675, which also lists 3 linked publications.
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 1 Oct 2024.