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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
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Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the innervation and muscle function of the urethra.
Women with these symptoms may benefit from treatment with medications to improve their urethral function. However, to truly understand what types of medications will help women with these symptoms, the investigators wish to study how these medications affect innervation and muscle function in healthy women who do not have lower urinary tract symptoms.
Women without urinary incontinence or bladder symptoms (healthy controls)will undergo urethral testing prior to randomization to one of 5 medications or placebo. Participants will take an oral medication for 2 weeks and then return for repeat testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pseudoephedrine | Active Comparator | Pseudoephedrine 120mg extended release tablets |
|
| Solifenacin | Active Comparator | Solifenacin 5mg capsule |
|
| Tamsulosin | Active Comparator | Tamsulosin 0.4mg capsule |
|
| Imipramine | Active Comparator | Imipramine 25mg tablet |
|
| Cyclobenzaprine | Active Comparator | Cyclobenzaprine 10mg tablet |
|
| Lactose capsules | Placebo Comparator | Sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pseudoephedrine | Drug | Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | 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. | 2 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Holly E Richter, PhD, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham, The Kirklin Clinic | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Pseudoephedrine 120mg ER Daily | 120 mg extended release tablet one daily for 14 days |
| FG001 | Solifenacin 5mg Daily | 5 mg capsule, one daily for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tamsulosin |
| Drug |
Tamsulosin 0.4mg by mouth daily for 2 weeks |
|
|
| Imipramine | Drug | Imipramine 25mg daily by mouth for 2 weeks |
|
|
| Cyclobenzaprine | Drug | Cyclobenzaprine 10mg daily by mouth for 2 weeks |
|
|
| Lactose capsule | Drug | Lactose capsule 1 by mouth daily for 2 weeks |
|
| Solifenacin | Drug | Solifenacin 5mg by mouth daily for 2 weeks |
|
|
| 2 weeks |
| Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry | 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. | 2 weeks |
| FG002 | Tamsulosin 0.4mg Daily | 0.4 mg capsule, one daily for 14 days |
| FG003 | Imipramine 25mg Daily | 25 mg tablet, one daily for 14 days |
| FG004 | Cyclobenzaprine 10mg Daily | 10 mg tablet, one daily for 14 days |
| FG005 | Lactose Capsules, One Daily | sham lactose capsules, one daily for 14 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pseudoephedrine 120mg ER Daily | 120 mg extended release, 1 daily for 14 days |
| BG001 | Solifenacin 5mg Daily | 5 mg capsule, 1 daily for 14 days |
| BG002 | Tamsulosin 0.4mg Daily | 0.4 mg capsule, 1 daily for 14 days |
| BG003 | Imipramine 25mg Daily | 25 mg tablet, 1 daily for 14 days |
| BG004 | Cyclobenzaprine 10mg Daily | 10 mg tablet, 1 daily for 14 days |
| BG005 | Lactose Capsules, One Daily | sham lactose capsules, 1 daily for 14 days |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | 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. | 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. | Posted | Median | Inter-Quartile Range | microvolts | 2 weeks |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | 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. | 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. | Posted | Median | Inter-Quartile Range | Milliamps | 2 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry | 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. | 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. | Posted | Median | Inter-Quartile Range | milliliters per second | 2 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pseudoephedrine 120mg ER Daily | 120mg extended release, one daily for 14 days | 0 | 10 | 2 | 10 | ||
| EG001 | Solifenacin 5mg Daily | 5 mg capsule, one daily for 14 days | 0 | 10 | 1 | 10 | ||
| EG002 | Tamsulosin 0.4mg Daily | 0.4 mg capsule, one daily for 14 days | 0 | 10 | 1 | 10 | ||
| EG003 | Imipramine 25mg Daily | 25 mg tablet, one daily for 14 days | 0 | 10 | 2 | 10 | ||
| EG004 | Cyclobenzaprine 10mg Daily | 10mg tablet, one daily for 14 days | 0 | 10 | 0 | 10 | ||
| EG005 | Lactose Capsules, One Daily | sham lactose capsules, one daily for 14 days | 0 | 6 | 1 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment | Dry mouth resolved after the first two days of study medication. |
| |
| Headaches | General disorders | Non-systematic Assessment | Reported migraine like headaches over the weekend. Headaches stopped two days later. No further problems with headaches. |
| |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | Subject had mild nausea at bedtime after taking study medication. Instructed to take medication iwth food at dinner time and the problem was resolved. |
| |
| Vaginal Yeast Infection | Reproductive system and breast disorders | Non-systematic Assessment | Problem resolved after she took Diflucan that she had at home. |
| |
| Voiding discomfort | Renal and urinary disorders | Non-systematic Assessment | Discomfort with voiding; improved with Azo-Standard. |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William Jerod Greer | University of Alabama at Birmingham | 205-934-7874 | wjgreer@uab.edu |
| ID | Term |
|---|---|
| D054199 | Pseudoephedrine |
| D000077409 | Tamsulosin |
| D007099 | Imipramine |
| C004704 | cyclobenzaprine |
| D007785 | Lactose |
| D000069464 | Solifenacin Succinate |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| No |
| Superiority or Other |
0.4 mg capsule, 1 daily for 14 days |
| OG003 | Imipramine 25mg Daily | 25 mg tablet, 1 daily for 14 days |
| OG004 | Cyclobenzaprine 10mg Daily | 10 mg tablet, 1 daily for 14 days |
| OG005 | Lactose Capsules, One Daily | sham lactose capsules, 1 daily for 14 days |
|
|
|
0.4 mg capsule, 1 daily for 14 days |
| OG003 | Imipramine 25mg Daily | 25 mg tablet, 1 daily for 14 days |
| OG004 | Cyclobenzaprine 10mg Daily | 10 mg tablet, 1 daily for 14 days |
| OG005 | Lactose Capsules, One Daily | sham lactose capsules, 1 daily for 14 days |
|
|