Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06484023
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-06-24
Brief Title:
Posterior Tibial Transcutaneous Neurostimulation in Idiopathic Overactive Bladder
Sponsor:
Hopital Nord Franche-Comte
Organization:
Hopital Nord Franche-Comte
Study Overview
Official Title:
Place and Efficacy of Treatment With Posterior Tibial Transcutaneous Neurostimulation in Women With Idiopathic Overactive Bladder
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENVESI
Brief Summary:
Overactive bladder is a clinical diagnosis affecting up to 17 of women The existing medical treatment anticholinergics has many side effects and is sometimes ineffective Neurostimulation of the posterior tibial nerve is a validated 3rd-line therapy after failure of perineal re-education and medication Studies on TENS have shown a real impact on patients quality of life and encourage its use in routine clinical practice TENSI medical device is a treatment for overactive bladder It is non-invasive placed over the posterior tibial nerve pathway and sends electrical stimulation via electrodes located on the skin Discreet and without side effects for users this treatment is indicated as 3rd-line treatment for people suffering from idiopathic overactive bladder with no contraindications The aim of this study is to assess the quality of life of patients using this device both before use and after at least 3 months of use
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None