Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Holly Richter, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01028014
First received: December 7, 2009
Last updated: June 1, 2012
Last verified: June 2012
Results First Received: June 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Urethral Sphincter Activity
Interventions: Drug: Pseudoephedrine
Drug: Tamsulosin
Drug: Imipramine
Drug: Cyclobenzaprine
Drug: Lactose capsule
Drug: Solifenacin

  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
Healthy women,ages 19-51 and up including pre-menopausal older women who have had a normal menstrual cycle for the prior 3 months.Participants were recruited via local newspaper. The first participant was enrolled 5/27/10. Recruitment ended August 31, 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pseudoephedrine 120mg ER Daily 120 mg extended release tablet one daily for 14 days
Solifenacin 5mg Daily 5 mg capsule, one daily for 14 days
Tamsulosin 0.4mg Daily 0.4 mg capsule, one daily for 14 days
Imipramine 25mg Daily 25 mg tablet, one daily for 14 days
Cyclobenzaprine 10mg Daily 10 mg tablet, one daily for 14 days
Lactose Capsules, One Daily sham lactose capsules, one daily for 14 days

Participant Flow:   Overall Study
    Pseudoephedrine 120mg ER Daily     Solifenacin 5mg Daily     Tamsulosin 0.4mg Daily     Imipramine 25mg Daily     Cyclobenzaprine 10mg Daily     Lactose Capsules, One Daily  
STARTED     10     10     10     10     10     6  
COMPLETED     9     8     10     9     9     4  
NOT COMPLETED     1     2     0     1     1     2  
Lost to Follow-up                 1                 2                 0                 1                 1                 2  



  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.
No text entered.

Reporting Groups
  Description
Pseudoephedrine 120mg ER Daily 120 mg extended release, 1 daily for 14 days
Solifenacin 5mg Daily 5 mg capsule, 1 daily for 14 days
Tamsulosin 0.4mg Daily 0.4 mg capsule, 1 daily for 14 days
Imipramine 25mg Daily 25 mg tablet, 1 daily for 14 days
Cyclobenzaprine 10mg Daily 10 mg tablet, 1 daily for 14 days
Lactose Capsules, One Daily sham lactose capsules, 1 daily for 14 days
Total Total of all reporting groups

Baseline Measures
    Pseudoephedrine 120mg ER Daily     Solifenacin 5mg Daily     Tamsulosin 0.4mg Daily     Imipramine 25mg Daily     Cyclobenzaprine 10mg Daily     Lactose Capsules, One Daily     Total  
Number of Participants  
[units: participants]
  10     10     10     10     10     6     56  
Age  
[units: participants]
             
<=18 years     0     0     0     0     0     0     0  
Between 18 and 65 years     10     10     10     10     10     6     56  
>=65 years     0     0     0     0     0     0     0  
Age  
[units: years]
Mean ( Full Range )
  36.6  
  ( 24 to 49 )  
  31.6  
  ( 21 to 35 )  
  35.5  
  ( 21 to 49 )  
  33.1  
  ( 21 to 50 )  
  38  
  ( 24 to 53 )  
  28.7  
  ( 21 to 35 )  
  34.3  
  ( 19 to 57 )  
Gender  
[units: participants]
             
Female     10     10     10     10     10     6     56  
Male     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
             
United States     10     10     10     10     10     6     56  



  Outcome Measures
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1.  Primary:   Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG   [ Time Frame: 2 weeks ]

2.  Other Pre-specified:   Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.   [ Time Frame: 2 weeks ]

3.  Other Pre-specified:   Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry   [ Time Frame: 2 weeks ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. William Jerod Greer
Organization: University of Alabama at Birmingham
phone: 205-934-7874
e-mail: wjgreer@uab.edu


No publications provided


Responsible Party: Holly Richter, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01028014     History of Changes
Other Study ID Numbers: VESI-9E03-UAB
Study First Received: December 7, 2009
Results First Received: June 29, 2011
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration