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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

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.


Condition or disease Intervention/treatment Phase
Urethral Sphincter Activity Drug: Pseudoephedrine Drug: Tamsulosin Drug: Imipramine Drug: Cyclobenzaprine Drug: Lactose capsule Drug: Solifenacin Not Applicable

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  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters
Study Start Date : April 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Arm Intervention/treatment
Active Comparator: Pseudoephedrine
Pseudoephedrine 120mg extended release tablets
Drug: Pseudoephedrine
Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks
Active Comparator: Solifenacin
Solifenacin 5mg capsule
Drug: Solifenacin
Solifenacin 5mg by mouth daily for 2 weeks
Other Name: VESIcare
Active Comparator: Tamsulosin
Tamsulosin 0.4mg capsule
Drug: Tamsulosin
Tamsulosin 0.4mg by mouth daily for 2 weeks
Other Name: Flomax
Active Comparator: Imipramine
Imipramine 25mg tablet
Drug: Imipramine
Imipramine 25mg daily by mouth for 2 weeks
Other Name: Tofranil
Active Comparator: Cyclobenzaprine
Cyclobenzaprine 10mg tablet
Drug: Cyclobenzaprine
Cyclobenzaprine 10mg daily by mouth for 2 weeks
Other Name: Flexeril
Placebo Comparator: Lactose capsules
Sham
Drug: Lactose capsule
Lactose capsule 1 by mouth daily for 2 weeks



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years to 51 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01028014


Locations
United States, Alabama
University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama, United States, 35233
Sponsors and Collaborators
University of Alabama at Birmingham
Astellas Pharma Inc
Investigators
Principal Investigator: Holly E Richter, PhD, MD University of Alabama at Birmingham

Publications of Results:
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.

Responsible Party: Holly Richter, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01028014     History of Changes
Other Study ID Numbers: VESI-9E03-UAB
First Posted: December 9, 2009    Key Record Dates
Results First Posted: September 5, 2011
Last Update Posted: June 8, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Tamsulosin
Solifenacin Succinate
Ephedrine
Amitriptyline
Imipramine
Pseudoephedrine
Cyclobenzaprine
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs