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

Not Applicable

Completed

Interventions: Drug: Lactose capsule
Drug: Pseudoephedrine
Drug: Solifenacin
Drug: Tamsulosin
Drug: Imipramine
Drug: Cyclobenzaprine

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.

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Lactose capsules	Lactose capsule	Sham
Pseudoephedrine	Pseudoephedrine	Pseudoephedrine 120mg extended release tablets
Solifenacin	Solifenacin	Solifenacin 5mg capsule
Tamsulosin	Tamsulosin	Tamsulosin 0.4mg capsule
Imipramine	Imipramine	Imipramine 25mg tablet
Cyclobenzaprine	Cyclobenzaprine	Cyclobenzaprine 10mg tablet

Primary Outcome Measures

Name	Time	Method
Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG	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.

Secondary Outcome Measures