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

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
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: Completed

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

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Primary outcome: Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG

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: 51 Years. Gender(s): Female.

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

Locations and Contacts

University of Alabama at Birmingham, The Kirklin Clinic, Birmingham, Alabama 35233, United States
Additional Information

Starting date: April 2010
Last updated: June 1, 2012

Page last updated: August 23, 2015

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