Clinical trial NCT01028014: Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters
Official title: Medication Effects on Periurethral Sensation, Urethral Sphincter Activity and Pressure Flow Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethral Sphincter Activity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Astellas Pharma Inc
First posted: 2009-12-09
Enrollment: 56
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
measure: Difference (Pre - Post) in Urethral Sensation (Milliamps) as Measured by Current Perception Threshold Testing.
timeFrame: 2 weeks
measure: Difference (Pre - Post) in Maximum Urine Flow Rate (Qmax) (Milliliters Per Second) as Measured by Pressure Flowmetry
timeFrame: 2 weeks
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham, The Kirklin Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Holly E Richter, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Greer WJ; Gleason J; Szychowski JM; Goode P; Kenton K; Richter HE. Medication Effects on Urethral Current Perception Thresholds and Pressure Flow Parameters. Fem Pelv Med Recons Surg 2011;17:S33.