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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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