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Trial record 37 of 47 for:    CYCLOBENZAPRINE

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

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ClinicalTrials.gov Identifier: NCT01028014
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : September 5, 2011
Last Update Posted : June 8, 2012
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Holly Richter, MD, University of Alabama at Birmingham

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Urethral Sphincter Activity
Interventions Drug: Pseudoephedrine
Drug: Tamsulosin
Drug: Imipramine
Drug: Cyclobenzaprine
Drug: Lactose capsule
Drug: Solifenacin
Enrollment 56
Recruitment Details 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  
Arm/Group Title Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Hide Arm/Group Description 120 mg extended release tablet one daily for 14 days 5 mg capsule, one daily for 14 days 0.4 mg capsule, one daily for 14 days 25 mg tablet, one daily for 14 days 10 mg tablet, one daily for 14 days sham lactose capsules, one daily for 14 days
Period Title: Overall Study
Started 10 10 10 10 10 6
Completed 9 8 10 9 9 4
Not Completed 1 2 0 1 1 2
Reason Not Completed
Lost to Follow-up             1             2             0             1             1             2
Arm/Group Title Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily Total
Hide Arm/Group Description 120 mg extended release, 1 daily for 14 days 5 mg capsule, 1 daily for 14 days 0.4 mg capsule, 1 daily for 14 days 25 mg tablet, 1 daily for 14 days 10 mg tablet, 1 daily for 14 days sham lactose capsules, 1 daily for 14 days Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 10 6 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 6 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
6
 100.0%
56
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 6 participants 56 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 6 participants 56 participants
Female
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
6
 100.0%
56
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 6 participants 56 participants
10 10 10 10 10 6 56
1.Primary Outcome
Title Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
Hide Description Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in MUP recruitment from weak effort to maximal contraction.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.
Arm/Group Title Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Hide Arm/Group Description:
120 mg extended release, 1 tablet daily for 14 days
5 mg capsule, 1 capsule daily for 14 days
0.4 mg capsule, 1 daily for 14 days
25 mg tablet, 1 daily for 14 days
10 mg tablet, 1 daily for 14 days
sham lactose capsules, 1 daily for 14 days
Overall Number of Participants Analyzed 8 8 10 9 9 4
Median (Inter-Quartile Range)
Unit of Measure: microvolts
-18
(-108 to 89)
10
(-56 to 60)
11
(-102 to 52)
-15
(-157 to 75)
12
(-71 to 104)
36
(23 to 45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pseudoephedrine 120mg ER Daily, Solifenacin 5mg Daily, Tamsulosin 0.4mg Daily, Imipramine 25mg Daily, Cyclobenzaprine 10mg Daily, Lactose Capsules, One Daily
Comments Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments P values comparing differences across groups, as well as within group changes, were all >0.05.P-values were not adjusted for multiple testing; p<0.05 was considered statistically significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Other Pre-specified Outcome
Title Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
Hide Description Current Perception Threshold testing was used to measure urethral sensation before and after 2 weeks of therapy with one of 6 randomly assigned medications. We performed CPT testing in the urethra using a Neurometer®, which is a constant current stimulator capable of delivering sine wave electrical stimuli at 3 frequencies (2000 Hz, 250 Hz and 5 Hz). At all 3 frequencies, the stimulus intensity was gradually increased until first perceived, and then decreased until no longer perceptible. CPT values were obtained using a semi-automated forced choice paradigm.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.
Arm/Group Title Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Hide Arm/Group Description:
120 mg extended release, 1 tablet daily for 14 days
5 mg capsule, 1 capsule daily for 14 days
0.4 mg capsule, 1 daily for 14 days
25 mg tablet, 1 daily for 14 days
10 mg tablet, 1 daily for 14 days
sham lactose capsules, 1 daily for 14 days
Overall Number of Participants Analyzed 8 8 10 9 9 4
Median (Inter-Quartile Range)
Unit of Measure: Milliamps
0.06
(0.0 to 0.68)
0.06
(-0.01 to 0.34)
-0.8
(-0.8 to 0.04)
-0.12
(-0.4 to 0.12)
0.0
(-0.16 to 0.28)
0.03
(-0.03 to 0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Pseudoephedrine 120mg ER Daily, Solifenacin 5mg Daily, Tamsulosin 0.4mg Daily, Imipramine 25mg Daily, Cyclobenzaprine 10mg Daily, Lactose Capsules, One Daily
Comments Using difference in EMG amplitude as primary outcome, assuming standard deviation of 6, we had greater than 80% power to detect a 10-microvolt change in urethral muscle activity with sample size of 9 participants per group. Due to non-normality and small sample sizes, non-parametric tests were used and data presented as median (IQR). Kruskal-Wallis p-values are reported to compare median scores across groups. Wilcoxon sign-test p-values are reported to evaluate 2-week change within groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments P values comparing differences across groups, as well as within group changes, were all >0.05.P-values were not adjusted for multiple testing; p<0.05 was considered statistically significant.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Other Pre-specified Outcome
Title Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
Hide Description Pressure Flowmetry was used to measure maximum urine flow rate (Qmax)before and after 2 weeks of therapy with one of 6 randomly assigned medications. A 300 cc bladder fill was performed through the catheter, the catheter was removed, and transurethral and transrectal pressure transducers were placed for the pressure flow study. Voiding was performed in the seated position. Information obtained for the database included Qmax, average flow rate, time to Qmax, detrusor pressure at maximum flow rate, voided volume, and a calculated post-void residual.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The planned number of participants was per protocol based on power calculation. Actual number may differ based on withdrawal from the study or loss to follow-up.Participants randomized to Pseudoephedrine 120 mg ER,Solifenacin 5 mg, Tamsulosin 0.4mg, Imipramine 25mg, Cyclobenzaprine 10 mg, or a sham Lactose capsule, 1 a day for 14 days.
Arm/Group Title Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Hide Arm/Group Description:
120 mg extended release, 1 tablet daily for 14 days
5 mg capsule, 1 capsule daily for 14 days
0.4 mg capsule, 1 daily for 14 days
25 mg tablet, 1 daily for 14 days
10 mg tablet, 1 daily for 14 days
sham lactose capsules, 1 daily for 14 days
Overall Number of Participants Analyzed 8 8 10 9 9 4
Median (Inter-Quartile Range)
Unit of Measure: milliliters per second
-7.3
(-23.8 to 7.2)
5.0
(-24.5 to 21.4)
-5.6
(-45.3 to 16.5)
-6.6
(-55.1 to 8.7)
10.3
(-30.1 to 31.9)
10.4
(-27.6 to 22.8)
Time Frame Adverse Event data were collected from 5/27/10, the date of first participant enrolled, until 9/20/10 when the last participant completed the study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Hide Arm/Group Description 120mg extended release, one daily for 14 days 5 mg capsule, one daily for 14 days 0.4 mg capsule, one daily for 14 days 25 mg tablet, one daily for 14 days 10mg tablet, one daily for 14 days sham lactose capsules, one daily for 14 days
All-Cause Mortality
Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pseudoephedrine 120mg ER Daily Solifenacin 5mg Daily Tamsulosin 0.4mg Daily Imipramine 25mg Daily Cyclobenzaprine 10mg Daily Lactose Capsules, One Daily
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/10 (20.00%)      1/10 (10.00%)      1/10 (10.00%)      2/10 (20.00%)      0/10 (0.00%)      1/6 (16.67%)    
Gastrointestinal disorders             
Dry Mouth * [1]  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
Nausea * [2]  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
General disorders             
Headaches * [3]  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/6 (0.00%)  0
Renal and urinary disorders             
Voiding discomfort * [4]  1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/6 (16.67%)  1
Reproductive system and breast disorders             
Vaginal Yeast Infection * [5]  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Dry mouth resolved after the first two days of study medication.
[2]
Subject had mild nausea at bedtime after taking study medication. Instructed to take medication iwth food at dinner time and the problem was resolved.
[3]
Reported migraine like headaches over the weekend. Headaches stopped two days later. No further problems with headaches.
[4]
Discomfort with voiding; improved with Azo-Standard.
[5]
Problem resolved after she took Diflucan that she had at home.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. William Jerod Greer
Organization: University of Alabama at Birmingham
Phone: 205-934-7874
EMail: wjgreer@uab.edu
Publications of Results:
Greer WJ; Gleason J; Szychowski JM; Goode P; Kenton K; Richter HE. Medication Effects on Urethral Current Perception Thresholds and Pressure Flow Parameters. Fem Pelv Med Recons Surg 2011;17:S33.
Layout table for additonal information
Responsible Party: Holly Richter, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01028014     History of Changes
Other Study ID Numbers: VESI-9E03-UAB
First Submitted: December 7, 2009
First Posted: December 9, 2009
Results First Submitted: June 29, 2011
Results First Posted: September 5, 2011
Last Update Posted: June 8, 2012