Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06616675
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1
Sponsor:
None
Organization:
None
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 15mgday for 2 months
PTENS Protocol
The treatment consisted of PTENS with the Neurodyn Portable TENS FES21 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 05 milliseconds was applied for 40 minutes with continuous stimulation 3 times a week for 20 sessions
Drug Treatment Protocol
The anticholinergic Fenazic Adium was used in a single dose of 15mgday for 2 months
PTENS Protocol
The treatment consisted of PTENS with the Neurodyn Portable TENS FES21 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 05 milliseconds was applied for 40 minutes with continuous stimulation 3 times a week for 20 sessions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None