Study to Determine Effects of Vesicare on Return to Continence Post- Radical Prostatectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00581061
Recruitment Status : Terminated (Study subjects were not compliant with study protocols.)
First Posted : December 27, 2007
Results First Posted : September 30, 2010
Last Update Posted : October 7, 2010
Astellas Pharma Inc
Information provided by:
University of California, Irvine

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 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 or disease Intervention/treatment Phase
Incontinence Drug: Vesicare Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy
Study Start Date : June 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Vesicare Treatment Drug: Vesicare
Vesicare will be taken daily for one or three months, depending on symptoms of subject.
Other Name: Solifenacin

Primary Outcome Measures :
  1. Time to Continence [ Time Frame: 12 months ]
    Time in days to achieve pad free urinary continence

Secondary Outcome Measures :
  1. Compliance [ Time Frame: 3 months ]
    Number of subjects that were in compliance with the study protocol and took medication for at least one month.

  2. Side Effects [ Time Frame: 3 months ]
    Number of people who experienced side effects while taking Vesicare, per study protocol.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00581061

United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Astellas Pharma Inc
Principal Investigator: Thomas Ahlering, MD University of California, Irvine

Responsible Party: Thomas Ahlering, MD, University of California, Irvine Identifier: NCT00581061     History of Changes
Other Study ID Numbers: 2007-5720
First Posted: December 27, 2007    Key Record Dates
Results First Posted: September 30, 2010
Last Update Posted: October 7, 2010
Last Verified: October 2010

Keywords provided by University of California, Irvine:
Robotic Prostatectomy

Additional relevant MeSH terms:
Solifenacin Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents