Ignite Creation Date:
2024-05-06 @ 12:15 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03715777
Status:
COMPLETED
Last Update Posted:
2020-08-11
First Post:
2018-10-18
Brief Title:
Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Sponsor:
Jose Alberola-Rubio
Organization:
Instituto de Investigacion Sanitaria La Fe
Study Overview
Official Title:
Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
Status:
COMPLETED
Status Verified Date:
2020-08
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:
SEMG
Brief Summary:
Chronic pelvic pain CPP is a common presenting complaint affecting approximately 15-40 of women aged 18-50 in western countries and 5-43 of women in most developing countries It is debilitating and has a large socio- economic impact with a 45reduction in work productivity and a 15 increase in absence from work in women with the condition Botulinum neurotoxin type A BoNTA has been suggested to improve pain in muscle spasm its role in CPP secondary to pelvic floor spasm has gained increasing interest However clinicians do not have a diagnosis tool to evaluate the CPP and the BoNTA treatment results
Design and develop an efficient and simple tool for the diagnosis and detection of pelvic floor muscle PFM dysfunction based on superficial electromyography EMG and perform 25 EMG registrations sessions in healthy patients and 25 EMG sessions in patients diagnoses with PFM that will be treated with BoNTA to and study the EMG signal before and after BoNTA administration
Design and develop an efficient and simple tool for the diagnosis and detection of pelvic floor muscle PFM dysfunction based on superficial electromyography EMG and perform 25 EMG registrations sessions in healthy patients and 25 EMG sessions in patients diagnoses with PFM that will be treated with BoNTA to and study the EMG signal before and after BoNTA administration
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?:
False
Is an FDA AA801 Violation?:
None