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

Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After 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 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.

Study Overview

• Status: Terminated
• Conditions: Incontinence
• Intervention / Treatment: Drug: Vesicare

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Continence	Time in days to achieve pad free urinary continence	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Number of subjects that were in compliance with the study protocol and took medication for at least one month.	3 months
Side Effects	Number of people who experienced side effects while taking Vesicare, per study protocol.	3 months

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: Astellas Pharma Inc
• Investigators: Principal Investigator: Thomas Ahlering, MD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: December 21, 2007
• First Submitted That Met QC Criteria: December 26, 2007
• First Posted (Estimate): December 27, 2007

Study Record Updates

• Last Update Posted (Estimate): October 7, 2010
• Last Update Submitted That Met QC Criteria: October 5, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Incontinence; Robotic Prostatectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: 2007-5720