Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
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 100,000 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 patient's 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 clinicaltrials.gov ID:
NCT00581061.