Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
Information source: University of Alabama at Birmingham
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urethral Sphincter Activity
Intervention: Pseudoephedrine (Drug); Tamsulosin (Drug); Imipramine (Drug); Cyclobenzaprine (Drug); Lactose capsule (Drug); Solifenacin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Alabama at Birmingham Official(s) and/or principal investigator(s):
Holly E Richter, PhD, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham
Overall contact:
Leslie Abdo, RN, CCRC, Phone: 205-934-1777, Email: labdo@uab.edu
Summary
Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions
of American women. Women may develop these problems because the nerves that control 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 nerve 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 benefit women
with these symptoms, the investigators wish to study how these medications affect the nerves
and muscle function in healthy women who don't leak urine.
Clinical Details
Official title: Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Uroflowmetry Parameters
Study design: Allocation: Randomized, Control: Placebo Control, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Difference in urethral sphincter activity as measured by quantitative EMG, Current Perception Thresholds, and Uroflowmetry parameters between baseline and post-treatment testing
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
Minimum age: 19 Years.
Maximum age: 50 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Healthy Females only
- Ages 19-50
- 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
Locations and Contacts
Leslie Abdo, RN, CCRC, Phone: 205-934-1777, Email: labdo@uab.edu
University of Alabama at Birmingham, The Kirklin Clinic, Birmingham, Alabama 35233, United States; Recruiting
Kathy Carter, RN, Phone: 205-934-1776, Email: kcarter@uabmc.edu
Leslie Abdo, RN, Phone: 205-934-1777, Email: labdo@uabmc.edu
W. Jerod Greer, MD, Sub-Investigator
Additional Information
Starting date: April 2010
Last updated: August 3, 2010
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