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

• Sponsor: University of California, Irvine (Other)
• Overall Status: Completed
• CT.gov ID: NCT01215721
• Collaborator: Astellas Pharma US, Inc. (Industry)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 31
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence	Drug: Vesicare	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Vesicare™ (Solifenacin) in the Treatment of Urinary Incontinence After Radical Prostatectomy
• Study Start Date: Oct 1, 2010
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Vesicare Vesicare 5mg daily for 90 days was prescribed for men presenting with post-Robotic Assisted Radical Prostatectomy (RARP) severe incontinence.	Drug: Vesicare; 5 mg daily; Other Names: Vesicare (Solifenacin)

Outcome Measures

Primary Outcome Measures

1. Time to Continence [12 months]

   Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Irvine Medical Center	Orange	California	United States	92868

Sponsors and Collaborators

• University of California, Irvine
• Astellas Pharma US, Inc.

Investigators

• Principal Investigator: Thomas Ahlering, MD, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Thomas E. Ahlering, Urology Account Contact, University of California, Irvine
• ClinicalTrials.gov Identifier: NCT01215721
• Other Study ID Numbers: 2007-5720-2
• First Posted: Oct 6, 2010
• Last Update Posted: Jan 23, 2014
• Last Verified: Dec 1, 2013

• Keywords provided by Thomas E. Ahlering, Urology Account Contact, University of California, Irvine: Incontinence; Robotic Prostatectomy; Prostate Cancer
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Solifenacin Succinate

Study Results

Participant Flow

Recruitment Details	Participants are limited to men undergoing a robot assistered radical prostatectomy at the University of California, Irvine.
Pre-assignment Detail	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.

Arm/Group Title	Vesicare
Arm/Group Description	Vesicare™ (Solifenacin) : 5 mg daily
Period Title: Overall Study
STARTED	40
COMPLETED	38
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Vesicare
Arm/Group Description	Vesicare™ (Solifenacin) : 5 mg daily
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	19 47.5%
>=65 years	21 52.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64.5 (7.3)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	40 100%
Region of Enrollment (participants) [Number]
United States	40 100%
Severely Incontinent Men Post RARP (Number) [Number]
Number [Participants]	40 100%

Outcome Measures

1. Primary Outcome

Title	Time to Continence
Description	Days to zero pad continence were assessed by patient self-reported Pad free continence declaration card.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Vesicare, 5mg Treatment Group
Arm/Group Description	Vesicare™ (Solifenacin) : 5 mg daily
Measure Participants	40
Median (Standard Deviation) [Days to Continence]	95 (128.8)

Adverse Events

Time Frame	Adverse event data were collected for the duration of 3 months from the time of medication administration.
Arm/Group Title	Vesicare, 5mg Treatment Group
Arm/Group Description	Vesicare™ (Solifenacin) : 5 mg daily
All Cause Mortality
	Vesicare, 5mg Treatment Group
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Vesicare, 5mg Treatment Group
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Other (Not Including Serious) Adverse Events
	Vesicare, 5mg Treatment Group
	Affected / at Risk (%)	# Events
Total	2/40 (5%)
Gastrointestinal disorders
Stomach Cramps	1/40 (2.5%)	1
General disorders
Faintness, Flushing	1/40 (2.5%)	1

Limitations/Caveats

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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.