Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
1 other identifier
interventional
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
September 5, 2011
CompletedJune 8, 2012
June 1, 2012
1 year
December 7, 2009
June 29, 2011
June 1, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
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
Other Outcomes (2)
Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
2 weeks
Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
2 weeks
Study Arms (6)
Pseudoephedrine
ACTIVE COMPARATORPseudoephedrine 120mg extended release tablets
Solifenacin
ACTIVE COMPARATORSolifenacin 5mg capsule
Tamsulosin
ACTIVE COMPARATORTamsulosin 0.4mg capsule
Imipramine
ACTIVE COMPARATORImipramine 25mg tablet
Cyclobenzaprine
ACTIVE COMPARATORCyclobenzaprine 10mg tablet
Lactose capsules
PLACEBO COMPARATORSham
Interventions
Cyclobenzaprine 10mg daily by mouth for 2 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Astellas Pharma Inccollaborator
Study Sites (1)
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, 35233, United States
Related Publications (1)
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.
RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. William Jerod Greer
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Holly E Richter, PhD, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 7, 2009
First Posted
December 9, 2009
Study Start
April 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
June 8, 2012
Results First Posted
September 5, 2011
Record last verified: 2012-06