Darifenacin Versus Parasacral Transcutaneous Electric Nerve Stimulation for Overactive Bladder Syndrome in Patients Infected With Human T-Lymphotropic Virus 1 - Randomized Open Clinical Trial
| Registry | NCT06616675 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 42 (Actual) |
| Sponsor | Hospital Universitário Professor Edgard Santos (Other) |
| Conditions | HTLV-1, Overactive Bladder Syndrome |
| Interventions | Darifenacin, Neuromodulation - Sacral nerve stimulation (Drug, device) |
| Dates | start 2022-03-16, primary completion 2023-12-20, completion 2023-12-20, first posted 2024-09-27, last updated 2024-10-01 |
| Locations | 1 site in Brazil |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Darifenacin Group | Active comparator | Drug: Darifenacin | Anticholinergic treatment for OAB |
| PTENS Group | Experimental | Device: Neuromodulation - Sacral nerve stimulation | Neuromodulation using transcutaneous electrical sacral nerves stimulation |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * HTLV-1 infection * Overactive bladder symptom * 18 years of age or older Exclusion Criteria: * HTLV-1 infected subjects with HAM * Stroke * Parkinson * HIV infection * Prostatic hyperplasia * Pacemaker use * Genitourinary tract infection * Glaucoma
| Facility | City | Country | Status |
|---|---|---|---|
| Ambulatório de HTLV-1 - Com HUPES | Salvador, Estado de Bahia | Brazil |