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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: Astellas Pharma Inc
• Treatments: Amitriptyline; Cyclobenzaprine; Ephedrine; Imipramine; Pseudoephedrine; Solifenacin Succinate; Tamsulosin

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