Trial · NCT01028014
Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
NCT01028014, Not applicable, Completed, University of Alabama at Birmingham; results first posted 2011-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters. Trials, record NCT01028014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01028014
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
- NCT number
- NCT01028014
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 56 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Urethral Sphincter Activity
- Interventions
- Pseudoephedrine, Tamsulosin, Imipramine, Cyclobenzaprine, Lactose capsule, Solifenacin
- First posted
- 2009-12-09
- Last updated
- 2012-06-08
- Results first posted
- 2011-09-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | 2 weeks | 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. |
| Other | Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | 2 weeks | 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. |
| Other | Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry | 2 weeks | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | 2 weeks | 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. | microvolts | MEDIAN |
| OTHER_PRE_SPECIFIED | Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | 2 weeks | 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. | Milliamps | MEDIAN |
| OTHER_PRE_SPECIFIED | Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry | 2 weeks | 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. | milliliters per second | MEDIAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | Pseudoephedrine 120mg ER Daily | -18 | Inter-Quartile Range -108 to 89 | microvolts | |
| Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | Solifenacin 5mg Daily | 10 | Inter-Quartile Range -56 to 60 | microvolts | |
| Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | Tamsulosin 0.4mg Daily | 11 | Inter-Quartile Range -102 to 52 | microvolts | |
| Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | Imipramine 25mg Daily | -15 | Inter-Quartile Range -157 to 75 | microvolts | |
| Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | Cyclobenzaprine 10mg Daily | 12 | Inter-Quartile Range -71 to 104 | microvolts | |
| Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG | Lactose Capsules, One Daily | 36 | Inter-Quartile Range 23 to 45 | microvolts | |
| Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | Pseudoephedrine 120mg ER Daily | 0.06 | Inter-Quartile Range 0.0 to 0.68 | Milliamps | |
| Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | Solifenacin 5mg Daily | 0.06 | Inter-Quartile Range -0.01 to 0.34 | Milliamps | |
| Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | Tamsulosin 0.4mg Daily | -0.8 | Inter-Quartile Range -0.8 to 0.04 | Milliamps | |
| Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing. | Imipramine 25mg Daily | -0.12 | Inter-Quartile Range -0.4 to 0.12 | Milliamps |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pseudoephedrine 120mg ER Daily | 10 | |
| Overall Study | STARTED | Solifenacin 5mg Daily | 10 | |
| Overall Study | STARTED | Tamsulosin 0.4mg Daily | 10 | |
| Overall Study | STARTED | Imipramine 25mg Daily | 10 | |
| Overall Study | STARTED | Cyclobenzaprine 10mg Daily | 10 | |
| Overall Study | STARTED | Lactose Capsules, One Daily | 6 | |
| Overall Study | COMPLETED | Pseudoephedrine 120mg ER Daily | 9 | |
| Overall Study | COMPLETED | Solifenacin 5mg Daily | 8 | |
| Overall Study | COMPLETED | Tamsulosin 0.4mg Daily | 10 | |
| Overall Study | COMPLETED | Imipramine 25mg Daily | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events30
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Dry Mouth | Gastrointestinal disorders | Pseudoephedrine 120mg ER Daily | 0 | 10 | 0 |
| other | Dry Mouth | Gastrointestinal disorders | Solifenacin 5mg Daily | 1 | 10 | 1 |
| other | Dry Mouth | Gastrointestinal disorders | Tamsulosin 0.4mg Daily | 0 | 10 | 0 |
| other | Dry Mouth | Gastrointestinal disorders | Imipramine 25mg Daily | 0 | 10 | 0 |
| other | Dry Mouth | Gastrointestinal disorders | Cyclobenzaprine 10mg Daily | 0 | 10 | 0 |
| other | Dry Mouth | Gastrointestinal disorders | Lactose Capsules, One Daily | 0 | 6 | 0 |
| other | Headaches | General disorders | Pseudoephedrine 120mg ER Daily | 0 | 10 | 0 |
| other | Headaches | General disorders | Solifenacin 5mg Daily | 0 | 10 | 0 |
| other | Headaches | General disorders | Tamsulosin 0.4mg Daily | 0 | 10 | 0 |
| other | Headaches | General disorders | Imipramine 25mg Daily | 1 | 10 | 1 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pseudoephedrine 120mg ER Daily | ||
| Total, all-cause mortality | Solifenacin 5mg Daily | ||
| Total, all-cause mortality | Tamsulosin 0.4mg Daily | ||
| Total, all-cause mortality | Imipramine 25mg Daily | ||
| Total, all-cause mortality | Cyclobenzaprine 10mg Daily | ||
| Total, all-cause mortality | Lactose Capsules, One Daily | ||
| Total, other adverse events | Pseudoephedrine 120mg ER Daily | 2 | 10 |
| Total, other adverse events | Solifenacin 5mg Daily | 1 | 10 |
| Total, other adverse events | Tamsulosin 0.4mg Daily | 1 | 10 |
| Total, other adverse events | Imipramine 25mg Daily | 2 | 10 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01028014
GET https://conductscience.org/api/trials/v1/NCT01028014/events?page=2