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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urethral Sphincter Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DRUG

Lactose capsule 1 by mouth daily for 2 weeks

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes