Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-16

Study Completion Date

2023-12-20

Brief Summary

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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.

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Detailed Description

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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

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HTLV-1 Overactive Bladder Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Darifenacin Group

Anticholinergic treatment for OAB

Group Type ACTIVE_COMPARATOR

Darifenacin

Intervention Type DRUG

Anticholinergic drug therapy for OAB treatment - Darifenacin, 15mg/day

PTENS Group

Neuromodulation using transcutaneous electrical sacral nerves stimulation

Group Type EXPERIMENTAL

Neuromodulation - Sacral nerve stimulation

Intervention Type DEVICE

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.

Interventions

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Darifenacin

Anticholinergic drug therapy for OAB treatment - Darifenacin, 15mg/day

Intervention Type DRUG

Neuromodulation - Sacral nerve stimulation

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No