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

Hospital Universitário Professor Edgard Santos

Status and phase: Completed; Phase 4

Conditions: HTLV-1; Overactive Bladder Syndrome

Treatments: Device: Neuromodulation - Sacral nerve stimulation; Drug: Darifenacin

Study type: Interventional

Funder types: Other

Identifiers

NCT06616675

CAAE: 59171022.9.0000.0049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

Darifenacin Group

Active Comparator group

Description:

Anticholinergic treatment for OAB

Treatment:

Drug: Darifenacin

PTENS Group

Experimental group

Description:

Neuromodulation using transcutaneous electrical sacral nerves stimulation

Treatment:

Device: Neuromodulation - Sacral nerve stimulation