Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters | RxWiki

Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Urethral Sphincter Activity
Intervention	Drug: Pseudoephedrine Drug: Tamsulosin Drug: Imipramine Drug: Cyclobenzaprine Drug: Lactose capsule Drug: Solifenacin
Phase	N/A
Sponsor	University of Alabama at Birmingham
Responsible Party	University of Alabama at Birmingham
ClinicalTrials.gov Identifier	NCT01028014
First Received	December 7, 2009
Last Updated	June 1, 2012
Last verified	June 2012

Tracking Information[ + expand ][ + ]

First Received Date	December 7, 2009
Last Updated Date	June 1, 2012
Start Date	April 2010
Estimated Primary Completion Date	April 2011
Current Primary Outcome Measures	Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG [Time Frame: 2 weeks] [Designated as safety issue: No]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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
Official Title	Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters
Brief Summary	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.
Detailed Description	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.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Condition	Urethral Sphincter Activity
Intervention	Drug: Pseudoephedrine Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks Drug: Tamsulosin Tamsulosin 0.4mg by mouth daily for 2 weeks Other Names: FlomaxDrug: Imipramine Imipramine 25mg daily by mouth for 2 weeks Other Names: TofranilDrug: Cyclobenzaprine Cyclobenzaprine 10mg daily by mouth for 2 weeks Other Names: FlexerilDrug: Lactose capsule Lactose capsule 1 by mouth daily for 2 weeks Drug: Solifenacin Solifenacin 5mg by mouth daily for 2 weeks Other Names: VESIcare
Study Arm (s)	Active Comparator: Pseudoephedrine Pseudoephedrine 120mg extended release tablets Active Comparator: Solifenacin Solifenacin 5mg capsule Active Comparator: Tamsulosin Tamsulosin 0.4mg capsule Active Comparator: Imipramine Imipramine 25mg tablet Active Comparator: Cyclobenzaprine Cyclobenzaprine 10mg tablet Placebo Comparator: Lactose capsules Sham

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	56
Estimated Completion Date	April 2011
Estimated Primary Completion Date	April 2011
Eligibility Criteria	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
Gender	Female
Ages	19 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01028014
Other Study ID Numbers	VESI-9E03-UAB
Has Data Monitoring Committee	Yes
Information Provided By	University of Alabama at Birmingham
Study Sponsor	University of Alabama at Birmingham
Collaborators	Astellas Pharma Inc
Investigators	Principal Investigator: Holly E Richter, PhD, MD University of Alabama at Birmingham
Verification Date	June 2012

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