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

Phase 4

Completed

• Conditions: HTLV-1; Overactive Bladder Syndrome
• Interventions: Device: Neuromodulation - Sacral nerve stimulation; Drug: Darifenacin

• Registration Number: NCT06616675
• Lead Sponsor: Hospital Universitário Professor Edgard Santos

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.

Study Timeline

• Study Start: 2022-03-16
• Primary Completion: 2023-12-20
• Study Completion: 2023-12-20
• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-09-25
• Study First Posted: 2024-09-27
• Last Update Submitted: 2024-09-29
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• HTLV-1 infection
• Overactive bladder symptom
• 18 years of age or older

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Exclusion Criteria

• HTLV-1 infected subjects with HAM
• Stroke
• Parkinson
• HIV infection
• Prostatic hyperplasia
• Pacemaker use
• Genitourinary tract infection
• Glaucoma

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTENS Group	Neuromodulation - Sacral nerve stimulation	Neuromodulation using transcutaneous electrical sacral nerves stimulation
Darifenacin Group	Darifenacin	Anticholinergic treatment for OAB

Primary Outcome Measures

Name	Time	Method
Overactive Bladder Symptom Score	2 months or 20 sessions	Whether higher scores mean worse outcome

Trial Locations

Locations (1)

Ambulatório de HTLV-1 - Com HUPES; 🇧🇷 Salvador, Ba, Brazil