Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Incontinence |
Drug: Vesicare |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy |
- Time to Continence [ Time Frame: 12 months ] [ Designated as safety issue: No ]Time in days to achieve pad free urinary continence
- Compliance [ Time Frame: 3 months ] [ Designated as safety issue: No ]Number of subjects that were in compliance with the study protocol and took medication for at least one month.
- Side Effects [ Time Frame: 3 months ] [ Designated as safety issue: No ]Number of people who experienced side effects while taking Vesicare, per study protocol.
| Enrollment: | 13 |
| Study Start Date: | June 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vesicare Treatment |
Drug: Vesicare
Vesicare will be taken daily for one or three months, depending on symptoms of subject.
Other Name: Solifenacin
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men diagnosed with prostate cancer undergoing robotic radical prostatectomy
- Incontinence
- Obesity
- Large prostate weight
- Mild and severe AUA symptom scores
- Urinary Bother
Exclusion Criteria:
- Contra-indication to Solifenacin
- Narrow angle glaucoma
- Hepatic impairment
- Renal impairment
- CYP3A4 inhibitors (e.g. Ketoconazole)
- Gastric Retention (delayed or slow emptying of the stomach)
Contacts and Locations| United States, California | |
| University of California, Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| Principal Investigator: | Thomas Ahlering, MD | University of California, Irvine |
More Information
No publications provided
| Responsible Party: | Thomas Ahlering, MD, University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00581061 History of Changes |
| Other Study ID Numbers: | 2007-5720 |
| Study First Received: | December 21, 2007 |
| Results First Received: | March 11, 2010 |
| Last Updated: | October 5, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of California, Irvine:
|
Incontinence Robotic Prostatectomy |
Additional relevant MeSH terms:
|
Urinary Incontinence Urination Disorders Urologic Diseases Urological Manifestations Signs and Symptoms Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013