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NCT00667095 · ClinicalTrials.gov registry record · Phase 3

Over Active Bladder Instillation Study - Botox

A Phase 3 study, sponsored by Mayo Clinic.

Terminated
Registry status
Phase 3
Development phase
25
Enrollment target

NCT00667095: Clinical Trial Phase 3 study, sponsored by Mayo Clinic.

NCT00667095 is a Phase 3 study that was terminated before completion, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00667095, a Phase 3 study, was terminated before completion, sponsored by Mayo Clinic.

TERMINATED
Registry status
Phase 3
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar group of women with OAB who receive instillation of DMSO only.

Primary Outcome

The I-QoL measures the effect of urinary incontinence on quality of life. It is divided into 3 subscales: 1) avoidance and limiting behavior, 2) psychosocial impact, and 3) social embarrassment. The I-QOL is comprised of 22 items, each with the response scale from '1= Extremely' to '5= Not at all'. A mean score for each subscale is calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores are then transfor

Interventions

  • DRUG Botox Instillation
  • DRUG DMSO Instillation

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2008-04
Est. Completion 2012-01
Phase Phase 3
Mayo Clinic

2,844 total trials

Why NCT00667095 stopped before completion

NCT00667095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 2 interventions - of which Botox Instillation is the first listed.

NCT00667095 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00667095 about?

NCT00667095 is a clinical study titled "Over Active Bladder Instillation Study - Botox". The purpose of this study is to determine whether women with overactive bladder (OAB) who receive direct instillation via a catheter of a Botulinum-A Toxin (Botox) with Dimethyl Sulfoxide (DMSO) solution experience significantly better improvement of their OAB symptoms when compared to a similar gro...

What is the current status of trial NCT00667095?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 25 participants. The study started on 2008-04. Estimated completion is 2012-01.

What interventions are being tested in trial NCT00667095?

The interventions under investigation include: Botox Instillation (DRUG), DMSO Instillation (DRUG).

Who is sponsoring clinical trial NCT00667095?

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

How this trial's enrollment target compares

Where NCT00667095's enrollment target sits among peer trials

25 1941st of 2000 higher than 58 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00667095, the US trial registry maintained by the National Library of Medicine. NCT00667095 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.