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

Darifenacin Versus Parasacral Transcutaneous Electric Nerve Stimulation for Overactive Bladder Syndrome in Patients Infected With Human T-Lymphotropic Virus 1 - Randomized Open Clinical Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06616675

Enrollment

Registered

2024-09-27

Start date

2022-03-16

Completion date

2023-12-20

Last updated

2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HTLV-1, Overactive Bladder Syndrome

Keywords

Electrical stimulation, Overactive bladder, HLTV-1, darifenacin

Brief 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.

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.

Interventions

DRUGDarifenacin

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

DEVICENeuromodulation - 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overactive Bladder Symptom Score	2 months or 20 sessions	Whether higher scores mean worse outcome

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026