Ignite Creation Date:
2024-05-06 @ 6:30 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05680168
Status:
RECRUITING
Last Update Posted:
2023-01-13
First Post:
2022-12-15
Brief Title:
Efficacy of Extracorporeal Magnetic Stimulation Pelvic Floor Muscle Exercise and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence
Sponsor:
Hamad General Hospital
Organization:
Hamad General Hospital
Study Overview
Official Title:
Efficacy of Extracorporeal Magnetic Stimulation Pelvic Floor Muscle Exercise and Combination of Both in Management of Post Radical Prostatectomy Urinary Incontinence A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-01
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:
Urinary incontinence is one of the most common complications of radical prostatectomy Multiple prevention and treatment modalities have been proposed in the management of post prostatectomy urinary incontinence This is a randomized controlled comparative study to evaluate the efficacy of extracorporeal magnetic stimulation alone and combined with pelvic floor muscle exercise versus pelvic floor muscle exercise alone in the management of post radical prostatectomy urinary incontinence This study is expected to be performed over 7 years The study population will be all male patients who are prepared for radical prostatectomy under urology department in HMC and were referred to voiding dysfunction for preoperative counselling and postoperative rehabilitation Patients will be randomized into one of three treatment groups The first group will receive sessions of extracorporeal magnetic field stimulation only The second group will receive extracorporeal magnetic stimulation in addition to pelvic floor muscle exercise The third group will receive pelvic floor muscle exercise only The recruitment phase will take 3 years Patients will be followed for 18 months for the course of urinary incontinence symptoms severity of urinary incontinence on 1-hour pad test urodynamic leak point pressure and the International Consultation on Incontinence Questionnaire - Short Form ICIQ-SF and the ICIQ quality of life QOL score This study is proposed to reveal strong evidence on the efficacy of extracorporeal magnetic stimulation on the management of post radical prostatectomy urinary incontinence
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