Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419517
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-14
Brief Title:
Pelvic Muscle Training and Electrostimulation to Treat Weak Pelvic Floor
Sponsor:
Azienda Unità Sanitaria Locale di Piacenza
Organization:
Azienda Unità Sanitaria Locale di Piacenza
Study Overview
Official Title:
Efficacy of PFMT and sEMG-triggered Electrostimulation in Treating the Very Weak Pelvic Floor a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This research will determine 1 whether the very weak pelvic floor can be improved with surface electromyography s-EMG-triggered electrostimulation added to pelvic floor muscle training and 2 whether sEMG-triggered electrostimulation added to pelvic floor muscle training can reduce leakage in Stress Urinary Incontinence SUI
Detailed Description:
Among women with pelvic floor dysfunction it has long been known that PFM training is the first-line therapy for stress incontinence One of the difficulties that clinicians often find upon examination is that many women present a very weak pelvic floor and are unable to contract their PFM There is overwhelming evidence to show that conservative treatment in the form of pelvic muscle exercises and to a lesser degree electrotherapy and vaginal weight therapy is effective in the treatment of stress urinary incontinence To date there is some evidence to support the use of electrical stimulation for stress urinary incontinence in women but we are still very uncertain about the full potential of this treatment because of the low quality of the existing evidence
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