Efficacy of Two Onabotulinum Toxin Doses

NCT ID: NCT03388086

Last Updated: 2019-08-06

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

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-07-31

Brief Summary

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The changes in bladder function after the injection of Onabotulinum toxin into the detrusor in individuals with neurogenic bladder overactivity will be investigated retrospectively. The records of all patients treated with Onabotulinum toxin injections into the detrusor since 2000 will be evaluated. The changes in the urodynamic values after the injection of 300 units of Onabotulinum toxin will be compared with the changes after the injection of 200 units. Furthermore, the differences in urinary continence, duration between injections, side effects and complications between the two groups will be investigated.

Detailed Description

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Conditions

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Neurogenic Bladder Overactive Detrusor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Onabotulinum 300 units

Injection of Onabotulinum toxin

Intervention Type DRUG

multiple injections of Onabotulinum toxin into the detrusor muscle

Onabotulinum 200 units

Injection of Onabotulinum toxin

Intervention Type DRUG

multiple injections of Onabotulinum toxin into the detrusor muscle

Interventions

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Injection of Onabotulinum toxin

multiple injections of Onabotulinum toxin into the detrusor muscle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* neurogenic detrusor overactivity
* spinal cord injury
* Onabotulinum toxin injections into the detrusor from 2000-2017

Exclusion Criteria

* missing urodynamic values before or after Onabotulinum toxin injections
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2017-17

Identifier Type: -

Identifier Source: org_study_id

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