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NCT01215721 · ClinicalTrials.gov registry record · NA
Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)
A NA study, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT01215721 is a NA study that has completed, run by University of California, Irvine. The registered enrollment target is 40 participants.
The verdict
NCT01215721, a NA study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 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 | 40 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01215721
The ClinicalTrials.gov registry entry for NCT01215721 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 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.
NCT01215721 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01215721 about?
NCT01215721 is a clinical study titled "Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)". 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 NCT01215721?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2010-10. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01215721?
The interventions under investigation include: Vesicare (DRUG).
Who is sponsoring clinical trial NCT01215721?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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