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

NCT06616675 | Completed Phase 4

• 1 other identifier: CAAE: 59171022.9.0000.0049
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

HTLV-1; Overactive Bladder Syndrome

Keywords

Electrical stimulation; Overactive bladder; HLTV-1; darifenacin

Outcome Measures

Primary Outcomes (1)

• Overactive Bladder Symptom Score

  Whether higher scores mean worse outcome

  2 months or 20 sessions

Study Arms (2)

Darifenacin Group

ACTIVE COMPARATOR

Anticholinergic treatment for OAB

Drug: Darifenacin

PTENS Group

EXPERIMENTAL

Neuromodulation using transcutaneous electrical sacral nerves stimulation

Device: Neuromodulation - Sacral nerve stimulation

Interventions

Darifenacin DRUG

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

Darifenacin Group

Neuromodulation - Sacral nerve stimulation 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.

PTENS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Universitário Professor Edgard Santos: lead

Study Sites (1)

Ambulatório de HTLV-1 - Com HUPES

Salvador, Estado de Bahia, 40110060, Brazil

Location

Related Publications (3)

• Liu Y, Xu G, Geng J. Efficacy of Transcutaneous Electrical Nerve Stimulation in the Management of Neurogenic Overactive Bladder: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2022 Jan 1;101(1):2-10. doi: 10.1097/PHM.0000000000001836.

  PMID: 34225282 RESULT

• Slovak M, Chapple CR, Barker AT. Non-invasive transcutaneous electrical stimulation in the treatment of overactive bladder. Asian J Urol. 2015 Apr;2(2):92-101. doi: 10.1016/j.ajur.2015.04.013. Epub 2015 Apr 16.

  PMID: 29264126 RESULT

• Andrade RC, Neto JA, Andrade L, Oliveira TS, Santos DN, Oliveira CJ, Prado MJ, Carvalho EM. Effects of Physiotherapy in the Treatment of Neurogenic Bladder in Patients Infected With Human T-Lymphotropic Virus 1. Urology. 2016 Mar;89:33-8. doi: 10.1016/j.urology.2015.09.036. Epub 2015 Dec 24.

  PMID: 26724409 RESULT

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

darifenacin

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: September 27, 2024
• Study Start: March 16, 2022
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)