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

The University of Alabama at Birmingham

Status: Completed

Conditions: Urethral Sphincter Activity

Treatments: Drug: Solifenacin; Drug: Pseudoephedrine; Drug: Cyclobenzaprine; Drug: Lactose capsule; Drug: Imipramine; Drug: Tamsulosin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01028014

VESI-9E03-UAB

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 19 to 51 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 6 patient groups, including a placebo group

Pseudoephedrine

Active Comparator group

Description:

Pseudoephedrine 120mg extended release tablets

Treatment:

Drug: Pseudoephedrine

Solifenacin

Active Comparator group

Description:

Solifenacin 5mg capsule

Treatment:

Drug: Solifenacin

Tamsulosin

Active Comparator group

Description:

Tamsulosin 0.4mg capsule

Treatment:

Drug: Tamsulosin

Imipramine

Active Comparator group

Description:

Imipramine 25mg tablet

Treatment:

Drug: Imipramine

Cyclobenzaprine

Active Comparator group

Description:

Cyclobenzaprine 10mg tablet

Treatment:

Drug: Cyclobenzaprine

Lactose capsules

Placebo Comparator group

Description:

Sham

Treatment:

Drug: Lactose capsule