Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06589869
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
Effect of High-Intensity Focused Electromagnetic HIFEM Technology in the Treatment of SUI in Chinese Men Undergone Robotic Radical Prostatectomy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
To Investigate the Effect of High-Intensity Focused Electromagnetic HIFEM Technology in the Treatment of Stress Urinary Incontinence Compared With Standard of Care in Chinese Men Who Had Undergone Robotic Radical Prostatectomy
Status:
RECRUITING
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:
This is a prospective randomized trial to evaluate the efficacy and safety of High-Intensity Focused Electromagnetic HIFEM Technology in the treatment of stress urinary incontinence compared with standard of care in Chinese men who had undergone robotic radical prostatectomy
Detailed Description:
This is a prospective randomised control trial of consecutive patients with prostatectomy to have either standard of care versus HIFEM assisted pelvic floor exercise Randomization will be performed for patients when the subject has completed the informed consent for study participation Randomization will be performed in 11 ratio into 2 arms HIFEM assisted BTL EMsella pelvic floor muscle training Arm A plus Standard of care or Standard of care Arm B
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