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

Study Overview
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Brief Summary
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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.

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

Conditions
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Incontinence

Intervention / Treatment
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* Drug: Vesicare


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vesicare Treatment<br> | Drug: Vesicare<br>* Vesicare will be taken daily for one or three months, depending on symptoms of subject.<br>* Other names: Solifenacin;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Incontinence, Robotic Prostatectomy