Clinical trial NCT06616675: Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1
Official title: Darifenacin Versus Parasacral Transcutaneous Electric Nerve Stimulation for Overactive Bladder Syndrome in Patients Infected With Human T-Lymphotropic Virus 1 - Randomized Open Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HTLV-1
Overactive Bladder Syndrome
Keywords: Electrical stimulation
Overactive bladder
HLTV-1
darifenacin
Lead sponsor: Hospital Universitário Professor Edgard Santos
Sponsor class: OTHER
First posted: 2024-09-27
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overactive Bladder Symptom Score
timeFrame: 2 months or 20 sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Ambulatório de HTLV-1 - Com HUPES
state: Ba
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.