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NCT00581061 · ClinicalTrials.gov registry record · NA
Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy
A NA study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- NA
- Development phase
- 13
- Enrollment target
NCT00581061 is a NA study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 13 participants.
The verdict
NCT00581061, a NA study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
Study 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 an
Interventions
- DRUG Vesicare
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2008-06 |
| Est. Completion | 2010-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00581061
The ClinicalTrials.gov registry entry for NCT00581061 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Vesicare is the first listed.
NCT00581061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00581061 about?
NCT00581061 is a clinical study titled "Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy". 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...
What is the current status of trial NCT00581061?
This trial is currently terminated. It is a NA study. The enrollment target is 13 participants. The study started on 2008-06. Estimated completion is 2010-02.
What interventions are being tested in trial NCT00581061?
The interventions under investigation include: Vesicare (DRUG).
Who is sponsoring clinical trial NCT00581061?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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