Urinary Incontinence
Conditions
Keywords
Incontinence, Robotic Prostatectomy, Prostate Cancer
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. \*This study has been modified from the original protocol with the clinicaltrials.gov ID: NCT00581061.
Interventions
DRUGVesicare
5 mg daily
Sponsors
Astellas Pharma US, Inc.
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Continence | 12 months | Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card. |
Countries
United States
Participant flow
Recruitment details
Participants are limited to men undergoing a robot assistered radical prostatectomy at the University of California, Irvine.
Pre-assignment details
Only men who at the 6th or 7th day post-catheter removal are multiple pad users (3 pads or more) will be invited to participate in this trial.
Participants by arm
| Arm | Count |
|---|---|
| Vesicare Vesicare™ (Solifenacin) : 5 mg daily | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
Baseline characteristics
| Characteristic | Vesicare |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 64.5 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment United States | 40 participants |
| Severely Incontinent Men Post RARP | 40 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Time to Continence
Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Vesicare, 5mg Treatment Group | Time to Continence | 95 Days to Continence | Standard Deviation 128.8 |