Study to Determine Effects of Vesicare on Return to Continence Post - Radical Prostatectomy (Part II)

Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215721
• Other study ID #: 2007-5720-2
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: December 4, 2013
• Start date: October 2010
• Est. completion date: May 2013

Study information

• Verified date: December 2013
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

*This study has been modified from the original protocol with the clinicaltrials.gov ID:

NCT00581061.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients that have been diagnosed with prostate cancer and will undergo treatment for the disease as part of standard clinical care

• Patients that have multiple pad use a few days after standard of care catheter removal

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)

• Lives in a different country

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Incontinence

Intervention

Drug:
• Vesicare
5 mg daily

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Continence	Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.	12 months	No

External Links

•   Department of Urology | University of California, Irvine
•   Robotic Prostatectomy | Thomas Ahlering, M.D. | Department of Urology