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Trial record 37 of 47 for:    CYCLOBENZAPRINE

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

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ClinicalTrials.gov Identifier: NCT01028014
Recruitment Status : Completed
First Posted : December 9, 2009
Results First Posted : September 5, 2011
Last Update Posted : June 8, 2012
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Holly Richter, MD, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE December 7, 2009
First Posted Date  ICMJE December 9, 2009
Results First Submitted Date  ICMJE June 29, 2011
Results First Posted Date  ICMJE September 5, 2011
Last Update Posted Date June 8, 2012
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2009)
Difference in urethral sphincter activity as measured by quantitative EMG, Current Perception Thresholds, and Uroflowmetry parameters between baseline and post-treatment testing [ Time Frame: 2 weeks ]
Change History Complete list of historical versions of study NCT01028014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Urethral Sphincter Activity
Intervention  ICMJE
  • 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 Name: Flomax
  • Drug: Imipramine
    Imipramine 25mg daily by mouth for 2 weeks
    Other Name: Tofranil
  • Drug: Cyclobenzaprine
    Cyclobenzaprine 10mg daily by mouth for 2 weeks
    Other Name: Flexeril
  • Drug: Lactose capsule
    Lactose capsule 1 by mouth daily for 2 weeks
  • Drug: Solifenacin
    Solifenacin 5mg by mouth daily for 2 weeks
    Other Name: VESIcare
Study Arms  ICMJE
  • Active Comparator: Pseudoephedrine
    Pseudoephedrine 120mg extended release tablets
    Intervention: Drug: Pseudoephedrine
  • Active Comparator: Solifenacin
    Solifenacin 5mg capsule
    Intervention: Drug: Solifenacin
  • Active Comparator: Tamsulosin
    Tamsulosin 0.4mg capsule
    Intervention: Drug: Tamsulosin
  • Active Comparator: Imipramine
    Imipramine 25mg tablet
    Intervention: Drug: Imipramine
  • Active Comparator: Cyclobenzaprine
    Cyclobenzaprine 10mg tablet
    Intervention: Drug: Cyclobenzaprine
  • Placebo Comparator: Lactose capsules
    Sham
    Intervention: Drug: Lactose capsule
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2011)
56
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2009)
50
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 51 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01028014
Other Study ID Numbers  ICMJE VESI-9E03-UAB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Holly Richter, MD, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Astellas Pharma Inc
Investigators  ICMJE
Principal Investigator: Holly E Richter, PhD, MD University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP