Trial Outcomes & Findings for Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters (NCT NCT01028014)
NCT ID: NCT01028014
Last Updated: 2012-06-08
Results Overview
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.
COMPLETED
NA
56 participants
2 weeks
2012-06-08
Participant Flow
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
Participant milestones
| Measure |
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
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
10
|
10
|
6
|
|
Overall Study
COMPLETED
|
9
|
8
|
10
|
9
|
9
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
0
|
1
|
1
|
2
|
Baseline Characteristics
Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
Baseline characteristics by cohort
| Measure |
Pseudoephedrine 120mg ER Daily
n=10 Participants
120 mg extended release, 1 daily for 14 days
|
Solifenacin 5mg Daily
n=10 Participants
5 mg capsule, 1 daily for 14 days
|
Tamsulosin 0.4mg Daily
n=10 Participants
0.4 mg capsule, 1 daily for 14 days
|
Imipramine 25mg Daily
n=10 Participants
25 mg tablet, 1 daily for 14 days
|
Cyclobenzaprine 10mg Daily
n=10 Participants
10 mg tablet, 1 daily for 14 days
|
Lactose Capsules, One Daily
n=6 Participants
sham lactose capsules, 1 daily for 14 days
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age Continuous
|
36.6 years
n=5 Participants
|
31.6 years
n=7 Participants
|
35.5 years
n=5 Participants
|
33.1 years
n=4 Participants
|
38 years
n=21 Participants
|
28.7 years
n=10 Participants
|
34.3 years
n=115 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
10 participants
n=21 Participants
|
6 participants
n=10 Participants
|
56 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Pseudoephedrine 120mg ER Daily
n=8 Participants
120 mg extended release, 1 tablet daily for 14 days
|
Solifenacin 5mg Daily
n=8 Participants
5 mg capsule, 1 capsule daily for 14 days
|
Tamsulosin 0.4mg Daily
n=10 Participants
0.4 mg capsule, 1 daily for 14 days
|
Imipramine 25mg Daily
n=9 Participants
25 mg tablet, 1 daily for 14 days
|
Cyclobenzaprine 10mg Daily
n=9 Participants
10 mg tablet, 1 daily for 14 days
|
Lactose Capsules, One Daily
n=4 Participants
sham lactose capsules, 1 daily for 14 days
|
|---|---|---|---|---|---|---|
|
Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
|
-18 microvolts
Interval -108.0 to 89.0
|
10 microvolts
Interval -56.0 to 60.0
|
11 microvolts
Interval -102.0 to 52.0
|
-15 microvolts
Interval -157.0 to 75.0
|
12 microvolts
Interval -71.0 to 104.0
|
36 microvolts
Interval 23.0 to 45.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Pseudoephedrine 120mg ER Daily
n=8 Participants
120 mg extended release, 1 tablet daily for 14 days
|
Solifenacin 5mg Daily
n=8 Participants
5 mg capsule, 1 capsule daily for 14 days
|
Tamsulosin 0.4mg Daily
n=10 Participants
0.4 mg capsule, 1 daily for 14 days
|
Imipramine 25mg Daily
n=9 Participants
25 mg tablet, 1 daily for 14 days
|
Cyclobenzaprine 10mg Daily
n=9 Participants
10 mg tablet, 1 daily for 14 days
|
Lactose Capsules, One Daily
n=4 Participants
sham lactose capsules, 1 daily for 14 days
|
|---|---|---|---|---|---|---|
|
Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
|
0.06 Milliamps
Interval 0.0 to 0.68
|
0.06 Milliamps
Interval -0.01 to 0.34
|
-0.8 Milliamps
Interval -0.8 to 0.04
|
-0.12 Milliamps
Interval -0.4 to 0.12
|
0.0 Milliamps
Interval -0.16 to 0.28
|
0.03 Milliamps
Interval -0.03 to 0.05
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Pseudoephedrine 120mg ER Daily
n=8 Participants
120 mg extended release, 1 tablet daily for 14 days
|
Solifenacin 5mg Daily
n=8 Participants
5 mg capsule, 1 capsule daily for 14 days
|
Tamsulosin 0.4mg Daily
n=10 Participants
0.4 mg capsule, 1 daily for 14 days
|
Imipramine 25mg Daily
n=9 Participants
25 mg tablet, 1 daily for 14 days
|
Cyclobenzaprine 10mg Daily
n=9 Participants
10 mg tablet, 1 daily for 14 days
|
Lactose Capsules, One Daily
n=4 Participants
sham lactose capsules, 1 daily for 14 days
|
|---|---|---|---|---|---|---|
|
Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
|
-7.3 milliliters per second
Interval -23.8 to 7.2
|
5.0 milliliters per second
Interval -24.5 to 21.4
|
-5.6 milliliters per second
Interval -45.3 to 16.5
|
-6.6 milliliters per second
Interval -55.1 to 8.7
|
10.3 milliliters per second
Interval -30.1 to 31.9
|
10.4 milliliters per second
Interval -27.6 to 22.8
|
Adverse Events
Pseudoephedrine 120mg ER Daily
Solifenacin 5mg Daily
Tamsulosin 0.4mg Daily
Imipramine 25mg Daily
Cyclobenzaprine 10mg Daily
Lactose Capsules, One Daily
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pseudoephedrine 120mg ER Daily
n=10 participants at risk
120mg extended release, one daily for 14 days
|
Solifenacin 5mg Daily
n=10 participants at risk
5 mg capsule, one daily for 14 days
|
Tamsulosin 0.4mg Daily
n=10 participants at risk
0.4 mg capsule, one daily for 14 days
|
Imipramine 25mg Daily
n=10 participants at risk
25 mg tablet, one daily for 14 days
|
Cyclobenzaprine 10mg Daily
n=10 participants at risk
10mg tablet, one daily for 14 days
|
Lactose Capsules, One Daily
n=6 participants at risk
sham lactose capsules, one daily for 14 days
|
|---|---|---|---|---|---|---|
|
General disorders
Headaches
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/6 • 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.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/10 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/6 • 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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/6 • 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.
|
|
Reproductive system and breast disorders
Vaginal Yeast Infection
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/6 • 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.
|
|
Renal and urinary disorders
Voiding discomfort
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
10.0%
1/10 • Number of events 1 • 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.
|
0.00%
0/10 • 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.
|
0.00%
0/10 • 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.
|
16.7%
1/6 • Number of events 1 • 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.
|
Additional Information
Dr. William Jerod Greer
University of Alabama at Birmingham
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place