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NCT01028014 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
NA
Development phase
56
Enrollment target

NCT01028014: Completed NA study, sponsored by University of Alabama at Birmingham.

NCT01028014 is a NA study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 56 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01028014, a NA study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
NA
Development phase
56 participants
Enrollment target

Study 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.

Primary Outcome

Concentric needle EMG was used to measure urethral sphincter activity at 2-3 sites around the urethral meatus before and after 2 weeks of therapy with one of 6 randomly assigned medications. Two methods of quantitative electromyography were performed on all subjects. (1) Multi-Motor Unit Action Potential (MUP) analysis, which has been shown to be the most sensitive technique in distinguishing neuropathic from control muscles; and (2) interference pattern analysis (IPA) which reflects changes in

Interventions

  • DRUG Cyclobenzaprine
  • DRUG Tamsulosin
  • DRUG Imipramine
  • DRUG Pseudoephedrine
  • DRUG Lactose capsule

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2010-04
Est. Completion 2011-04
Phase NA
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01028014 record still lists

NCT01028014 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclobenzaprine is the first listed.

NCT01028014 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01028014 about?

NCT01028014 is a clinical study titled "Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters". 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 ...

What is the current status of trial NCT01028014?

This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2010-04. Estimated completion is 2011-04.

What interventions are being tested in trial NCT01028014?

The interventions under investigation include: Cyclobenzaprine (DRUG), Tamsulosin (DRUG), Imipramine (DRUG), Pseudoephedrine (DRUG), Lactose capsule (DRUG).

Who is sponsoring clinical trial NCT01028014?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01028014's enrollment target sits among peer trials

56 1262nd of 2000 higher than 737 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01028014, the US trial registry maintained by the National Library of Medicine. NCT01028014 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.