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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Holly Richter, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01028014
First received: December 7, 2009
Last updated: June 1, 2012
Last verified: June 2012

December 7, 2009
June 1, 2012
April 2010
April 2011   (final data collection date for primary outcome measure)
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.
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01028014 on ClinicalTrials.gov Archive Site
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Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Urethral Sphincter Activity
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Female
19 Years to 51 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01028014
VESI-9E03-UAB
Yes
Holly Richter, MD, University of Alabama at Birmingham
University of Alabama at Birmingham
Astellas Pharma Inc
Principal Investigator: Holly E Richter, PhD, MD University of Alabama at Birmingham
University of Alabama at Birmingham
June 2012

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