Ignite Creation Date:
2024-05-06 @ 1:32 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01832831
Status:
TERMINATED
Last Update Posted:
2016-04-21
First Post:
2013-04-10
Brief Title:
Anatomical and Functional Differences Between Continent and Incontinent Men Post Radical Prostatectomy
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was completed as planned
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
One out of every six men will be diagnosed with prostate cancer and post prostatectomy up to 75 report urinary incontinence There are many hypotheses about the exact cause of post prostatectomy stress incontinence PPI Existing studies have focused on surgical or cadaveric dissections to define structures responsible for PPI Contemporary 3T MRI now allows three dimensional sub-millimeter resolution of the human pelvis and clearly demonstrates pelvic anatomy without the distortion of dissection It is our overarching hypothesis that PPI is multifactorial and occurs because of a combination of specific anatomical and functional impairments We propose conducting a case control study with matching for age and race to compare the MRI anatomy and urinary tract function on urodynamics between 20 men with PPI cases and 20 men who are continent post prostatectomy controls who are all a minimum of 12 months post surgery We will use static and dynamic MRI at 3 Tesla to make objective measurements of the bladder neck external urethral sphincter pelvic floor urethral anastomotic fibrosis and urethral hypermobility- all believed to play a large part in continence Multi-channel urodynamic studies will also be performed to assess the leak point and maximum urethral closure pressure All cases and controls will complete standardized questionnaires - the AUA symptom index and the Incontinence Severity Index as a quality of life measure This study is needed to provide critical information about causes of male PPI a quality of life altering voiding dysfunction and will assist with the advancement of pharmacological and surgical treatment of this disease
Detailed Description:
None
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