Ignite Creation Date:
2024-05-05 @ 10:54 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01215721
Status:
COMPLETED
Last Update Posted:
2014-01-23
First Post:
2010-10-05
Brief Title:
Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy Part II
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
Vesicare Solifenacin in the Treatment of Urinary Incontinence After Radical Prostatectomy
Status:
COMPLETED
Status Verified Date:
2013-12
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:
Prostate cancer is the most common non-cutaneous malignancy in men and is the 2nd leading cause of death from cancer in men Radical prostatectomy is one of the treatment options available for organ-confined disease Over 100000 radical prostatectomies cases total removal of the cancerous prostate by surgery are performed in the United States yearly Unfortunately nearly all of the men undergoing surgery report diminished Quality of Life QOL scores due in part due to a postoperative incontinence which may require the use of multiple urinary pads per day Many of these men also report debilitating irritative voiding symptoms of urinary urgency and frequency and have overall decreased urinary satisfaction scores Abatement of these symptoms can take up to one year in men and in 5-20 of patients symptoms may persist for longer periods
Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence This Detrusor Muscle instability results in excess contractions of the urinary bladder urgency to urinate and can result in the feeling of needing to urinate more frequently Consistent with this hypothesis of detrusor muscle instability men with postoperative dribbling had more complaints with urgency frequency and bother scores when queried with validated questionnaires We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patients dribbling of urine
By treating the bladder muscle instability we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate This pilot study will assess the statistical requirements for the number of subjects needed for a fully powered randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients quality of urinary life and improve postoperative urinary incontinence after surgery
This study has been modified from the original protocol with the clinicaltrialsgov ID NCT00581061
Our recent published findings suggest that instability in the bladder muscle is likely an underlying etiology in postoperative urinary incontinence This Detrusor Muscle instability results in excess contractions of the urinary bladder urgency to urinate and can result in the feeling of needing to urinate more frequently Consistent with this hypothesis of detrusor muscle instability men with postoperative dribbling had more complaints with urgency frequency and bother scores when queried with validated questionnaires We suspect that a transient bladder muscle contraction may overcome the urinary sphincter valve resistance and result in the patients dribbling of urine
By treating the bladder muscle instability we expect improved postoperative continence and improved quality of life in patients after undergoing surgery for total removal of a cancerous prostate This pilot study will assess the statistical requirements for the number of subjects needed for a fully powered randomized prospective study to fully evaluate whether medications such as solifenacin significantly improve patients quality of urinary life and improve postoperative urinary incontinence after surgery
This study has been modified from the original protocol with the clinicaltrialsgov ID NCT00581061
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