Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130306
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2023-11-05
Brief Title:
A PSM Analysis to Evaluate Electrical Pudendal Nerve Stimulation for PPI
Sponsor:
Shanghai Institute of Acupuncture Moxibustion and Meridian
Organization:
Shanghai Institute of Acupuncture Moxibustion and Meridian
Study Overview
Official Title:
Electrical Pudendal Nerve Stimulation Versus Pelvic Floor Muscle Training Plus Transanal Electrical Stimulation for Post-Radical Prostatectomy Incontinence A Propensity Score Matching Analysis
Status:
RECRUITING
Status Verified Date:
2023-08
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:
None
Brief Summary:
The goal of this propensity score matching study is to compare the posttreatment outcomes of post-radical prostatectomy Incontinence patients undergoing either electrical pudendal nerve stimulation or pelvic floor muscle training combined with transanal electrical stimulation
Detailed Description:
Prostate cancer is the predominant form of cancer in older males Radical prostatectomy RP is the sole treatment that enhances both overall survival and cancer-specific survivalUrinary incontinence remains a major morbidity associated with this procedure greatly affecting patient satisfaction following RP Extant research underscores the efficacy of pelvic floor muscle training PFMT in improving the strength and function of specific pelvic floor muscles causing hypertrophy of peri-urethral striated muscles thereby increasing the external mechanical pressure on the urethra Another promising physiotherapy for post-radical prostatectomy incontinence PPI is electrical pudendal nerve stimulation EPNS An increasing body of research focuses on comparing continence restoration outcomes between PFMT and various electrical stimulations However such studies encompass cases with multiple pathological characteristics and the reported data might not be considered representative or applicable to other populations due to overlooked confounding factors or selection bias Thus the investigators intend to conduct a propensity score matching PSM study aiming to compare the posttreatment outcomes of patients undergoing either EPNS or PFMT combined with TES while ensuring a well-balanced control for confounding factor
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