University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, 35233, United States
Completed
NCT Number: NCT01028014
Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
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.
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Notify MeKey information
Conditions
Age range
19 year–51 year
Sex eligibility
Female
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy Females only
- Ages 19-51 and up including pre-menopausal older women who have had a normal menstrual cycle for the prior 3 months
- Able to take oral medication for 2 weeks
- For women of child bearing potential,willing to use an approved method of birth control during the study
Exclusion criteria
- Urinary Incontinence or other bladder symptoms
- Known neurologic disease that may impair urethral tone or sensation
- Currently taking a class of medication that is being tested (alpha-antagonists, anticholinergics, sympathomimetics, tricyclic antidepressants, or skeletal muscle relaxants)
- History of QTc prolongation or cardiac arrhythmia
- Pregnant, breastfeeding, or are less than 6 months postpartum
- Known hypersensitivity to or other contraindications to taking any of the study medications
Treatment and study plan
pseudoephedrine
DrugPseudoephedrine ER 120 mg by mouth once daily for 2 weeks
Tamsulosin
DrugTamsulosin 0.4mg by mouth daily for 2 weeks
Other names: Flomax
Imipramine
DrugImipramine 25mg daily by mouth for 2 weeks
Other names: Tofranil
Cyclobenzaprine
DrugCyclobenzaprine 10mg daily by mouth for 2 weeks
Other names: Flexeril
Lactose capsule
DrugLactose capsule 1 by mouth daily for 2 weeks
solifenacin
DrugSolifenacin 5mg by mouth daily for 2 weeks
Other names: VESIcare
Primary outcomes
-
Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
Time frame: 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 outcomes
-
Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
Time frame: 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.
-
Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
Time frame: 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.
Sponsors and collaborators
Lead sponsor
University of Alabama at Birmingham
Other
Collaborators
- Astellas Pharma Inc
Registry information
Official study title
Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Dec 9, 2009
- Registry last updated
- Jun 8, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.