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NCT00583219 · ClinicalTrials.gov registry record · Phase 1

Botulin-A Toxin Instillations and Overactive Bladder

A Phase 1 study of Overactive Bladder and Detrusor Hyperreflexia, sponsored by Mayo Clinic.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target
1
Study location

NCT00583219 is a Phase 1 study of Overactive Bladder and Detrusor Hyperreflexia that has completed, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 211-participant average among 45 other Overactive Bladder trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00583219, a Phase 1 study of Overactive Bladder and Detrusor Hyperreflexia, has completed, sponsored by Mayo Clinic.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.

Conditions Studied

Overactive Bladder Detrusor Hyperreflexia Detrusor Instability

Interventions

  • DRUG Botulinum-A toxin
  • DRUG Dimethyl sulfoxide (DMSO)

Study Locations (1)

Florida

  • Mayo Clinic Jacksonville - Jacksonville

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2006-03
Est. Completion 2008-05
Phase Phase 1

Sponsor

Mayo Clinic

2,844 total trials

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What the Registry Record Tells You About NCT00583219

The ClinicalTrials.gov registry entry for NCT00583219 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 211-participant average among 45 other Overactive Bladder trials with a reported enrollment target (88% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Overactive Bladder appearing as the primary indexed condition, and to 2 interventions - of which Botulinum-A toxin is the first listed.

NCT00583219 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT00583219 about?

NCT00583219 is a clinical study titled "Botulin-A Toxin Instillations and Overactive Bladder". The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on...

What is the current status of trial NCT00583219?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2006-03. Estimated completion is 2008-05.

What conditions does trial NCT00583219 study?

This clinical trial studies the following conditions: Overactive Bladder, Detrusor Hyperreflexia, Detrusor Instability.

What interventions are being tested in trial NCT00583219?

The interventions under investigation include: Botulinum-A toxin (DRUG), Dimethyl sulfoxide (DMSO) (DRUG).

Who is sponsoring clinical trial NCT00583219?

This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00583219 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.