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

NCT01028014 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2012-06-08

Study results available
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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.

Conditions

  • Urethral Sphincter Activity

Interventions

DRUG

Pseudoephedrine

Pseudoephedrine ER 120 mg by mouth once daily for 2 weeks

DRUG

Tamsulosin

Tamsulosin 0.4mg by mouth daily for 2 weeks

DRUG

Imipramine

Imipramine 25mg daily by mouth for 2 weeks

DRUG

Cyclobenzaprine

Cyclobenzaprine 10mg daily by mouth for 2 weeks

DRUG

Lactose capsule

Lactose capsule 1 by mouth daily for 2 weeks

DRUG

Solifenacin

Solifenacin 5mg by mouth daily for 2 weeks

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Holly E Richter, PhD, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
51 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-04-30
Completion
2011-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028014 on ClinicalTrials.gov