{"protocolSection":{"identificationModule":{"nctId":"NCT01028014","orgStudyIdInfo":{"id":"VESI-9E03-UAB"},"organization":{"fullName":"University of Alabama at Birmingham","class":"OTHER"},"briefTitle":"Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters","officialTitle":"Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters"},"statusModule":{"statusVerifiedDate":"2012-06","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2010-04"},"primaryCompletionDateStruct":{"date":"2011-04","type":"ACTUAL"},"completionDateStruct":{"date":"2011-04","type":"ACTUAL"},"studyFirstSubmitDate":"2009-12-07","studyFirstSubmitQcDate":"2009-12-08","studyFirstPostDateStruct":{"date":"2009-12-09","type":"ESTIMATED"},"resultsFirstSubmitDate":"2011-06-29","resultsFirstSubmitQcDate":"2011-08-03","resultsFirstPostDateStruct":{"date":"2011-09-05","type":"ESTIMATED"},"lastUpdateSubmitDate":"2012-06-01","lastUpdatePostDateStruct":{"date":"2012-06-08","type":"ESTIMATED"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Holly Richter, MD","investigatorTitle":"Principal Investigator","investigatorAffiliation":"University of Alabama at Birmingham"},"leadSponsor":{"name":"University of Alabama at Birmingham","class":"OTHER"},"collaborators":[{"name":"Astellas Pharma Inc","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"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.\n\nWomen 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.","detailedDescription":"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."},"conditionsModule":{"conditions":["Urethral Sphincter Activity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"BASIC_SCIENCE","maskingInfo":{"masking":"DOUBLE","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":56,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Pseudoephedrine","type":"ACTIVE_COMPARATOR","description":"Pseudoephedrine 120mg extended release tablets","interventionNames":["Drug: Pseudoephedrine"]},{"label":"Solifenacin","type":"ACTIVE_COMPARATOR","description":"Solifenacin 5mg capsule","interventionNames":["Drug: Solifenacin"]},{"label":"Tamsulosin","type":"ACTIVE_COMPARATOR","description":"Tamsulosin 0.4mg capsule","interventionNames":["Drug: Tamsulosin"]},{"label":"Imipramine","type":"ACTIVE_COMPARATOR","description":"Imipramine 25mg tablet","interventionNames":["Drug: Imipramine"]},{"label":"Cyclobenzaprine","type":"ACTIVE_COMPARATOR","description":"Cyclobenzaprine 10mg tablet","interventionNames":["Drug: Cyclobenzaprine"]},{"label":"Lactose capsules","type":"PLACEBO_COMPARATOR","description":"Sham","interventionNames":["Drug: Lactose capsule"]}],"interventions":[{"type":"DRUG","name":"Pseudoephedrine","description":"Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks","armGroupLabels":["Pseudoephedrine"]},{"type":"DRUG","name":"Tamsulosin","description":"Tamsulosin 0.4mg by mouth daily for 2 weeks","armGroupLabels":["Tamsulosin"],"otherNames":["Flomax"]},{"type":"DRUG","name":"Imipramine","description":"Imipramine 25mg daily by mouth for 2 weeks","armGroupLabels":["Imipramine"],"otherNames":["Tofranil"]},{"type":"DRUG","name":"Cyclobenzaprine","description":"Cyclobenzaprine 10mg daily by mouth for 2 weeks","armGroupLabels":["Cyclobenzaprine"],"otherNames":["Flexeril"]},{"type":"DRUG","name":"Lactose capsule","description":"Lactose capsule 1 by mouth daily for 2 weeks","armGroupLabels":["Lactose capsules"]},{"type":"DRUG","name":"Solifenacin","description":"Solifenacin 5mg by mouth daily for 2 weeks","armGroupLabels":["Solifenacin"],"otherNames":["VESIcare"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG","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.","timeFrame":"2 weeks"}],"otherOutcomes":[{"measure":"Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.","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.","timeFrame":"2 weeks"},{"measure":"Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry","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.","timeFrame":"2 weeks"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy Females only\n* Ages 19-51 and up including pre-menopausal older women who have had a normal menstrual cycle for the prior 3 months\n* Able to take oral medication for 2 weeks\n* For women of child bearing potential,willing to use an approved method of birth control during the study\n\nExclusion Criteria:\n\n* Urinary Incontinence or other bladder symptoms\n* Known neurologic disease that may impair urethral tone or sensation\n* Currently taking a class of medication that is being tested (alpha-antagonists, anticholinergics, sympathomimetics, tricyclic antidepressants, or skeletal muscle relaxants)\n* History of QTc prolongation or cardiac arrhythmia\n* Pregnant, breastfeeding, or are less than 6 months postpartum\n* Known hypersensitivity to or other contraindications to taking any of the study medications","healthyVolunteers":true,"sex":"FEMALE","minimumAge":"19 Years","maximumAge":"51 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Holly E Richter, PhD, MD","affiliation":"University of Alabama at Birmingham","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of Alabama at Birmingham, The Kirklin Clinic","city":"Birmingham","state":"Alabama","zip":"35233","country":"United States","geoPoint":{"lat":33.52066,"lon":-86.80249}}]},"referencesModule":{"references":[{"type":"RESULT","citation":"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."}]}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"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","groups":[{"id":"FG000","title":"Pseudoephedrine 120mg ER Daily","description":"120 mg extended release tablet one daily for 14 days"},{"id":"FG001","title":"Solifenacin 5mg Daily","description":"5 mg capsule, one daily for 14 days"},{"id":"FG002","title":"Tamsulosin 0.4mg Daily","description":"0.4 mg capsule, one daily for 14 days"},{"id":"FG003","title":"Imipramine 25mg Daily","description":"25 mg tablet, one daily for 14 days"},{"id":"FG004","title":"Cyclobenzaprine 10mg Daily","description":"10 mg tablet, one daily for 14 days"},{"id":"FG005","title":"Lactose Capsules, One Daily","description":"sham lactose capsules, one daily for 14 days"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"10"},{"groupId":"FG001","numSubjects":"10"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"10"},{"groupId":"FG004","numSubjects":"10"},{"groupId":"FG005","numSubjects":"6"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"9"},{"groupId":"FG001","numSubjects":"8"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"9"},{"groupId":"FG004","numSubjects":"9"},{"groupId":"FG005","numSubjects":"4"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"},{"groupId":"FG004","numSubjects":"1"},{"groupId":"FG005","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Pseudoephedrine 120mg ER Daily","description":"120 mg extended release, 1 daily for 14 days"},{"id":"BG001","title":"Solifenacin 5mg Daily","description":"5 mg capsule, 1 daily for 14 days"},{"id":"BG002","title":"Tamsulosin 0.4mg Daily","description":"0.4 mg capsule, 1 daily for 14 days"},{"id":"BG003","title":"Imipramine 25mg Daily","description":"25 mg tablet, 1 daily for 14 days"},{"id":"BG004","title":"Cyclobenzaprine 10mg Daily","description":"10 mg tablet, 1 daily for 14 days"},{"id":"BG005","title":"Lactose Capsules, One Daily","description":"sham lactose capsules, 1 daily for 14 days"},{"id":"BG006","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"10"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"56"}]}],"measures":[{"title":"Age, Categorical","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"<=18 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]},{"title":"Between 18 and 65 years","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"10"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"56"}]},{"title":">=65 years","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]}]}]},{"title":"Age Continuous","paramType":"MEAN","dispersionType":"FULL_RANGE","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36.6","lowerLimit":"24","upperLimit":"49"},{"groupId":"BG001","value":"31.6","lowerLimit":"21","upperLimit":"35"},{"groupId":"BG002","value":"35.5","lowerLimit":"21","upperLimit":"49"},{"groupId":"BG003","value":"33.1","lowerLimit":"21","upperLimit":"50"},{"groupId":"BG004","value":"38","lowerLimit":"24","upperLimit":"53"},{"groupId":"BG005","value":"28.7","lowerLimit":"21","upperLimit":"35"},{"groupId":"BG006","value":"34.3","lowerLimit":"19","upperLimit":"57"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"10"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"56"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"0"},{"groupId":"BG004","value":"0"},{"groupId":"BG005","value":"0"},{"groupId":"BG006","value":"0"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","categories":[{"measurements":[{"groupId":"BG000","value":"10"},{"groupId":"BG001","value":"10"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"10"},{"groupId":"BG004","value":"10"},{"groupId":"BG005","value":"6"},{"groupId":"BG006","value":"56"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG","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.","populationDescription":"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.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"microvolts","timeFrame":"2 weeks","groups":[{"id":"OG000","title":"Pseudoephedrine 120mg ER Daily","description":"120 mg extended release, 1 tablet daily for 14 days"},{"id":"OG001","title":"Solifenacin 5mg Daily","description":"5 mg capsule, 1 capsule daily for 14 days"},{"id":"OG002","title":"Tamsulosin 0.4mg Daily","description":"0.4 mg capsule, 1 daily for 14 days"},{"id":"OG003","title":"Imipramine 25mg Daily","description":"25 mg tablet, 1 daily for 14 days"},{"id":"OG004","title":"Cyclobenzaprine 10mg Daily","description":"10 mg tablet, 1 daily for 14 days"},{"id":"OG005","title":"Lactose Capsules, One Daily","description":"sham lactose capsules, 1 daily for 14 days"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-18","lowerLimit":"-108","upperLimit":"89"},{"groupId":"OG001","value":"10","lowerLimit":"-56","upperLimit":"60"},{"groupId":"OG002","value":"11","lowerLimit":"-102","upperLimit":"52"},{"groupId":"OG003","value":"-15","lowerLimit":"-157","upperLimit":"75"},{"groupId":"OG004","value":"12","lowerLimit":"-71","upperLimit":"104"},{"groupId":"OG005","value":"36","lowerLimit":"23","upperLimit":"45"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004","OG005"],"groupDescription":"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.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","pValueComment":"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.","statisticalMethod":"Wilcoxon (Mann-Whitney)"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.","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.","populationDescription":"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.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"Milliamps","timeFrame":"2 weeks","groups":[{"id":"OG000","title":"Pseudoephedrine 120mg ER Daily","description":"120 mg extended release, 1 tablet daily for 14 days"},{"id":"OG001","title":"Solifenacin 5mg Daily","description":"5 mg capsule, 1 capsule daily for 14 days"},{"id":"OG002","title":"Tamsulosin 0.4mg Daily","description":"0.4 mg capsule, 1 daily for 14 days"},{"id":"OG003","title":"Imipramine 25mg Daily","description":"25 mg tablet, 1 daily for 14 days"},{"id":"OG004","title":"Cyclobenzaprine 10mg Daily","description":"10 mg tablet, 1 daily for 14 days"},{"id":"OG005","title":"Lactose Capsules, One Daily","description":"sham lactose capsules, 1 daily for 14 days"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.06","lowerLimit":"0.0","upperLimit":"0.68"},{"groupId":"OG001","value":"0.06","lowerLimit":"-0.01","upperLimit":"0.34"},{"groupId":"OG002","value":"-0.8","lowerLimit":"-0.8","upperLimit":"0.04"},{"groupId":"OG003","value":"-0.12","lowerLimit":"-0.4","upperLimit":"0.12"},{"groupId":"OG004","value":"0.0","lowerLimit":"-0.16","upperLimit":"0.28"},{"groupId":"OG005","value":"0.03","lowerLimit":"-0.03","upperLimit":"0.05"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002","OG003","OG004","OG005"],"groupDescription":"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.","testedNonInferiority":false,"nonInferiorityType":"SUPERIORITY_OR_OTHER","pValue":">0.05","pValueComment":"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.","statisticalMethod":"Wilcoxon (Mann-Whitney)"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry","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.","populationDescription":"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.","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"milliliters per second","timeFrame":"2 weeks","groups":[{"id":"OG000","title":"Pseudoephedrine 120mg ER Daily","description":"120 mg extended release, 1 tablet daily for 14 days"},{"id":"OG001","title":"Solifenacin 5mg Daily","description":"5 mg capsule, 1 capsule daily for 14 days"},{"id":"OG002","title":"Tamsulosin 0.4mg Daily","description":"0.4 mg capsule, 1 daily for 14 days"},{"id":"OG003","title":"Imipramine 25mg Daily","description":"25 mg tablet, 1 daily for 14 days"},{"id":"OG004","title":"Cyclobenzaprine 10mg Daily","description":"10 mg tablet, 1 daily for 14 days"},{"id":"OG005","title":"Lactose Capsules, One Daily","description":"sham lactose capsules, 1 daily for 14 days"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"10"},{"groupId":"OG003","value":"9"},{"groupId":"OG004","value":"9"},{"groupId":"OG005","value":"4"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-7.3","lowerLimit":"-23.8","upperLimit":"7.2"},{"groupId":"OG001","value":"5.0","lowerLimit":"-24.5","upperLimit":"21.4"},{"groupId":"OG002","value":"-5.6","lowerLimit":"-45.3","upperLimit":"16.5"},{"groupId":"OG003","value":"-6.6","lowerLimit":"-55.1","upperLimit":"8.7"},{"groupId":"OG004","value":"10.3","lowerLimit":"-30.1","upperLimit":"31.9"},{"groupId":"OG005","value":"10.4","lowerLimit":"-27.6","upperLimit":"22.8"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"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.","eventGroups":[{"id":"EG000","title":"Pseudoephedrine 120mg ER Daily","description":"120mg extended release, one daily for 14 days","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":2,"otherNumAtRisk":10},{"id":"EG001","title":"Solifenacin 5mg Daily","description":"5 mg capsule, one daily for 14 days","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":1,"otherNumAtRisk":10},{"id":"EG002","title":"Tamsulosin 0.4mg Daily","description":"0.4 mg capsule, one daily for 14 days","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":1,"otherNumAtRisk":10},{"id":"EG003","title":"Imipramine 25mg Daily","description":"25 mg tablet, one daily for 14 days","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":2,"otherNumAtRisk":10},{"id":"EG004","title":"Cyclobenzaprine 10mg Daily","description":"10mg tablet, one daily for 14 days","seriousNumAffected":0,"seriousNumAtRisk":10,"otherNumAffected":0,"otherNumAtRisk":10},{"id":"EG005","title":"Lactose Capsules, One Daily","description":"sham lactose capsules, one daily for 14 days","seriousNumAffected":0,"seriousNumAtRisk":6,"otherNumAffected":1,"otherNumAtRisk":6}],"otherEvents":[{"term":"Dry Mouth","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Dry mouth resolved after the first two days of study medication.","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":6}]},{"term":"Headaches","organSystem":"General disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Reported migraine like headaches over the weekend. Headaches stopped two days later. No further problems with headaches.","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":6}]},{"term":"Nausea","organSystem":"Gastrointestinal disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Subject had mild nausea at bedtime after taking study medication. Instructed to take medication iwth food at dinner time and the problem was resolved.","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG003","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":6}]},{"term":"Vaginal Yeast Infection","organSystem":"Reproductive system and breast disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Problem resolved after she took Diflucan that she had at home.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG002","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG005","numEvents":0,"numAffected":0,"numAtRisk":6}]},{"term":"Voiding discomfort","organSystem":"Renal and urinary disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"Discomfort with voiding; improved with Azo-Standard.","stats":[{"groupId":"EG000","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG001","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG002","numEvents":1,"numAffected":1,"numAtRisk":10},{"groupId":"EG003","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG004","numEvents":0,"numAffected":0,"numAtRisk":10},{"groupId":"EG005","numEvents":1,"numAffected":1,"numAtRisk":6}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":true,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. William Jerod Greer","organization":"University of Alabama at Birmingham","email":"wjgreer@uab.edu","phone":"205-934-7874"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"},"interventionBrowseModule":{"meshes":[{"id":"D054199","term":"Pseudoephedrine"},{"id":"D000077409","term":"Tamsulosin"},{"id":"D007099","term":"Imipramine"},{"id":"C004704","term":"cyclobenzaprine"},{"id":"D007785","term":"Lactose"},{"id":"D000069464","term":"Solifenacin Succinate"}],"ancestors":[{"id":"D011412","term":"Propanolamines"},{"id":"D000605","term":"Amino Alcohols"},{"id":"D000438","term":"Alcohols"},{"id":"D009930","term":"Organic Chemicals"},{"id":"D020005","term":"Propanols"},{"id":"D000588","term":"Amines"},{"id":"D010627","term":"Phenethylamines"},{"id":"D005021","term":"Ethylamines"},{"id":"D000096926","term":"Benzenesulfonamides"},{"id":"D013449","term":"Sulfonamides"},{"id":"D000577","term":"Amides"},{"id":"D001555","term":"Benzene Derivatives"},{"id":"D006841","term":"Hydrocarbons, Aromatic"},{"id":"D006844","term":"Hydrocarbons, Cyclic"},{"id":"D006838","term":"Hydrocarbons"},{"id":"D013450","term":"Sulfones"},{"id":"D013457","term":"Sulfur Compounds"},{"id":"D003984","term":"Dibenzazepines"},{"id":"D006575","term":"Heterocyclic Compounds, 3-Ring"},{"id":"D000072471","term":"Heterocyclic Compounds, Fused-Ring"},{"id":"D006571","term":"Heterocyclic Compounds"},{"id":"D004187","term":"Disaccharides"},{"id":"D009844","term":"Oligosaccharides"},{"id":"D011134","term":"Polysaccharides"},{"id":"D002241","term":"Carbohydrates"},{"id":"D000073893","term":"Sugars"},{"id":"D011812","term":"Quinuclidines"},{"id":"D006572","term":"Heterocyclic Compounds, Bridged-Ring"},{"id":"D044005","term":"Tetrahydroisoquinolines"},{"id":"D007546","term":"Isoquinolines"},{"id":"D006574","term":"Heterocyclic Compounds, 2-Ring"}]}},"hasResults":true}