A Phase 4 interventional study of Darifenacin and Neuromodulation - Sacral nerve stimulation in HTLV-1 and Overactive Bladder Syndrome, sponsored by Hospital Universitário Professor Edgard Santos. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Hospital Universitário Professor Edgard Santos · Phase 4, Interventional, and Treatment
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.
858 studies on the registry are indexed under Urinary Bladder, Overactive; 127 are open to participants now.
This study's enrollment of 42 is below the median of 70 across 649 interventional studies indexed under Urinary Bladder, Overactive.
Browse Urinary Bladder, Overactive studies →Hospital Universitário Professor Edgard Santos is the lead sponsor of 17 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anticholinergic treatment for OAB
Drug: Darifenacin
Neuromodulation using transcutaneous electrical sacral nerves stimulation
Device: Neuromodulation - Sacral nerve stimulation
Anticholinergic drug therapy for OAB treatment - Darifenacin, 15mg/day
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.
Overactive Bladder Symptom Score
Whether higher scores mean worse outcome
Time frame: 2 months or 20 sessions
Plan to share: No
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Hospital Universitário Professor Edgard Santos