Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters - Full Text View

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:

Drug Information available for: Imipramine Pseudoephedrine Imipramine hydrochloride Cyclobenzaprine Cyclobenzaprine hydrochloride Imipramine pamoate Tamsulosin Tamsulosin hydrochloride Solifenacin succinate

U.S. FDA Resources

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

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:

Pseudoephedrine
Ephedrine
Cyclobenzaprine
Amitriptyline
Imipramine
Tamsulosin
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Central Nervous System Agents
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Muscle Relaxants, Central

ClinicalTrials.gov processed this record on May 16, 2013