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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
  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 Intervention
Urethral Sphincter Activity
Drug: Pseudoephedrine
Drug: Tamsulosin
Drug: Imipramine
Drug: Cyclobenzaprine
Drug: Lactose capsule
Drug: Solifenacin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

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.


Enrollment: 56
Study Start Date: April 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 51 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: December 7, 2009
Results First Received: June 29, 2011
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Amitriptyline
Cyclobenzaprine
Ephedrine
Imipramine
Pseudoephedrine
Solifenacin
Tamsulosin
Adrenergic Agents
Adrenergic Antagonists
Adrenergic Uptake Inhibitors
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Analgesics
Analgesics, Non-Narcotic
Anti-Asthmatic Agents
Antidepressive Agents
Antidepressive Agents, Tricyclic
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Muscle Relaxants, Central
Nasal Decongestants
Neuromuscular Agents

ClinicalTrials.gov processed this record on November 19, 2014