Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458491
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Brief Title:
Urinary Symptoms After Posterior Tibial Nerve Stimulation
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Evolution of Urinary Symptoms After Use of TENSI Posterior Tibial Nerve Stimulation for 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:
TENSI
Brief Summary:
Overactive bladder OAB is a common syndrome affecting 7 million people in France very often of idiopathic origin
Current therapeutic management of OAB primarily involves hygiene and diet rules patient education behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation However the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness
In the event of persistent symptoms the management of OAB is essentially based on the prescription of an anticholinergic medication The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses But the side effects of anticholinergics are known and some are very common particularly dry mouth and constipation
The principle of the posterior tibial nerve stimulation TNS by implanted percutaneous or adhesive transcutaneous electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session
TNS is also possible transcutaneously TENS with daily 20-minute stimulation of the ankle in the form of a self-administered treatment at home over a period of 3 months This treatment modality seems equivalent to the percutaneous approach
Given its numerous advantages the use of TENS is therefore expanding and is currently recommended by many learned societies SIFUD AFU
In this study we wish to evaluate the TENSI medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder
Current therapeutic management of OAB primarily involves hygiene and diet rules patient education behavioral measures with bladder reprogramming or even perineo-sphincter rehabilitation However the modalities of this conservative non-drug treatment are poorly defined and there is uncertainty as to their effectiveness
In the event of persistent symptoms the management of OAB is essentially based on the prescription of an anticholinergic medication The effectiveness of anticholinergics has been established through numerous randomized clinical trials and meta-analyses But the side effects of anticholinergics are known and some are very common particularly dry mouth and constipation
The principle of the posterior tibial nerve stimulation TNS by implanted percutaneous or adhesive transcutaneous electrode is to stimulate the sensory afferent pathways and to ensure negative feedback on the bladder Posterior tibial nerve stimulation is a non-invasive therapeutic alternative that has demonstrated its effectiveness through numerous clinical studies mainly using a device for percutaneous use with a weekly stimulation session
TNS is also possible transcutaneously TENS with daily 20-minute stimulation of the ankle in the form of a self-administered treatment at home over a period of 3 months This treatment modality seems equivalent to the percutaneous approach
Given its numerous advantages the use of TENS is therefore expanding and is currently recommended by many learned societies SIFUD AFU
In this study we wish to evaluate the TENSI medical device which uses transcutaneous posterior tibial nerve stimulation and which is offered in routine practice to patients with idiopathic or neurological overactive bladder
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