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A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01371994
First received: June 10, 2011
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: October 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Urinary Incontinence
Interventions: Drug: solifenacin succinate
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study population consisted of male patients > 18 years of age who were diagnosed with prostate cancer, treated by robotic assisted radical prostatectomy (RARP) and had urinary incontinence for 1 week following removal of the indwelling catheter.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants meeting the Baseline criteria were randomized 1:1 to 5 mg solifenacin succinate or matching placebo.

Reporting Groups
  Description
Placebo Participants received matching placebo tablets once a day for 12 weeks.
Solifenacin Succinate Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.

Participant Flow:   Overall Study
    Placebo   Solifenacin Succinate
STARTED   320   320 
Received Treatment   310   313 
COMPLETED   263   278 
NOT COMPLETED   57   42 
Adverse Event                3                6 
Lack of Efficacy                3                0 
Withdrawal by Subject                13                7 
Lost to Follow-up                1                1 
Protocol Violation                24                17 
Randomized but Never Received Study Drug                6                6 
Physician Decision                1                1 
Miscellaneous Reasons                6                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety analysis set, defined as all participants who took at least one dose of study drug.

Reporting Groups
  Description
Placebo Participants received matching placebo tablets once a day for 12 weeks.
Solifenacin Succinate Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
Total Total of all reporting groups

Baseline Measures
   Placebo   Solifenacin Succinate   Total 
Overall Participants Analyzed 
[Units: Participants]
 310   313   623 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.2  (6.72)   60.5  (7.21)   60.9  (6.98) 
Gender 
[Units: Participants]
     
Female   0   0   0 
Male   310   313   623 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   263   266   529 
Black   43   44   87 
Asian   2   3   5 
Other   2   0   2 
Race/Ethnicity, Customized 
[Units: Participants]
     
Not Hispanic or Latino   284   284   568 
Hispanic or Latino   26   29   55 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time From First Dose to Urinary Continence   [ Time Frame: 12 weeks ]

2.  Secondary:   Percentage of Participants Who Gain Continence During 12-week Treatment Period   [ Time Frame: Weeks 4, 8, and 12 ]

3.  Secondary:   Average Daily Pad Usage at Baseline   [ Time Frame: Baseline (7 days prior to Day 1) ]

4.  Secondary:   Change From Baseline in Average Daily Pad Usage   [ Time Frame: Baseline and Weeks 4, 8 and 12 ]

5.  Secondary:   American Urology Association Symptom Score (AUASS) at Baseline   [ Time Frame: Baseline ]

6.  Secondary:   Change From Baseline in American Urology Association Symptom Score (AUASS)   [ Time Frame: Baseline and Week 12 ]

7.  Secondary:   American Urology Association Quality of Life (QOL) Score at Baseline   [ Time Frame: Baseline ]

8.  Secondary:   Change From Baseline in American Urology Association Quality of Life (QOL) Score   [ Time Frame: Baseline and Week 12 ]

9.  Secondary:   International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score at Baseline   [ Time Frame: Baseline ]

10.  Secondary:   Change From Baseline in International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) QOL Score   [ Time Frame: Baseline and Week 12 ]

11.  Secondary:   Baseline Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed   [ Time Frame: Baseline ]

12.  Secondary:   Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed   [ Time Frame: Baseline and Week 12 ]

13.  Secondary:   Baseline Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working   [ Time Frame: Baseline ]

14.  Secondary:   Change From Baseline in Work Productivity Assessment Index (WPAI): Percent Impairment While Working   [ Time Frame: Baseline and Week 12 ]

15.  Secondary:   Baseline Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment   [ Time Frame: Baseline ]

16.  Secondary:   Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment   [ Time Frame: Baseline and Week 12 ]

17.  Secondary:   Baseline Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment   [ Time Frame: Baseline ]

18.  Secondary:   Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment   [ Time Frame: Baseline and Week 12 ]

19.  Secondary:   Time From Baseline to First Day of Returning to Work   [ Time Frame: From Baseline to Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director, Urology
Organization: Astellas Pharma Global Development, Inc.
e-mail: clinicaltrials@us.astellas.com



Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01371994     History of Changes
Other Study ID Numbers: 905-UC-050
Study First Received: June 10, 2011
Results First Received: October 6, 2014
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada