N/A N=56 Randomized Double-blind Basic Science

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

Urethral Sphincter Activity

Bottom Line

View on ClinicalTrials.gov: NCT01028014 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2011

Primary outcome: Primary: Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG — -18; 10; 11; -15 microvolts — p=>0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pseudoephedrine (Drug); Tamsulosin (Drug); Imipramine (Drug); Cyclobenzaprine (Drug); Lactose capsule (Drug); Solifenacin (Drug)
Age: Adult · 19+ yrs
Sex: Female
Sponsor: University of Alabama at Birmingham
Primary completion: Apr 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference (Pre - Post) in Amplitude (Microvolts) of Urethral Sphincter Activity as Measured by Quantitative Concentric Needle EMG	-18; 10; 11; -15; 12; 36	>0.05

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.

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

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Data sourced from ClinicalTrials.gov (NCT01028014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.