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| Name | Class |
|---|---|
| Astellas Pharma US, Inc. | INDUSTRY |
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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.
*This study has been modified from the original protocol with the clinicaltrials.gov ID: NCT00581061.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vesicare | Experimental | Vesicare 5mg daily for 90 days was prescribed for men presenting with post-Robotic Assisted Radical Prostatectomy (RARP) severe incontinence. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vesicare | Drug | 5 mg daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Continence | Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Ahlering, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine Medical Center | Orange | California | 92868 | United States |
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| Label | URL |
|---|---|
| Department of Urology \| University of California, Irvine | View source |
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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 are limited to men undergoing a robot assistered radical prostatectomy at the University of California, Irvine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Vesicare | Vesicare™ (Solifenacin) : 5 mg daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline Population: Men presenting with urinary incontinence requiring 3 pads or more at post-catheter day 6 or 7 after RARP (robotic assisted radical prostatectomy).
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| ID | Title | Description |
|---|---|---|
| BG000 | Vesicare | Vesicare™ (Solifenacin) : 5 mg daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Continence | Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card. | Posted | Median | Standard Deviation | Days to Continence | 12 months |
|
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Adverse event data were collected for the duration of 3 months from the time of medication administration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vesicare, 5mg Treatment Group | Vesicare™ (Solifenacin) : 5 mg daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach Cramps | Gastrointestinal disorders | Systematic Assessment | The patient was dehydrated while on the Vesicare medication, and as a result, suffered from a an episode of intense abdominal pain and constipation. The patient stopped taking the study medication and was not hospitalized. |
One limitation of this study was finding a reasonable Control group. This is problematic as symptoms that definitively identify detrusor overactivity preoperatively don't exist; hence we used pad usage 7 dys post catheter removal as a surrogate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Ahlering, MD | UC Irvine | 714-456-6068 | tahlerin@uci.edu |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D044005 | Tetrahydroisoquinolines |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Severely Incontinent Men Post RARP | Only men who were experiencing severe incontinence were screened for possible enrollment on to the study. Men who were utilizing 3 or more pads at post-catheter day 6 or 7 were deemed severely incontinent, and were invited to participate int he trial. | Number | Participants |
|
|
| 0 |
| 40 |
| 2 |
| 40 |
|
| Faintness, Flushing | General disorders | Systematic Assessment | This patient was concomitantly taking the study medication Vesicare in addition to Viagra (Sildenafil citrate). During dinner the patient suffered shock, faintness, and flushing. The patient did visit the emergency room. |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |