Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence

NCT ID: NCT00770406

Last Updated: 2009-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-06-30

Brief Summary

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A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.

Detailed Description

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Conditions

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Urge Urinary Incontinence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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botulinum toxin type A

100 or 200 units intravesically

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* refractory urge urinary incontinence

Exclusion Criteria

* neurological disease
* pregnant or lactating
* bladder neoplasias
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Glostrup University Hospital,Copenhagen

Locations

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Glostrup Hospital

Glostrup Municipality, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Soren Brostrom, MD, PhD

Role: CONTACT

+45-43232243

Other Identifiers

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BTXA2008

Identifier Type: -

Identifier Source: org_study_id

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