Efficacy of Two Onabotulinum Toxin Doses

August 5, 2019 updated by: Swiss Paraplegic Centre Nottwil

Comparing the Efficacy of Two Doses of Onabotulinum Toxin for the Treatment of Neurogenic Detrusor Overactivity - a Retrospective Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • LU
      • Nottwil, LU, Switzerland, 6207
        • Swiss Paraplegic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients treated with Onabotulinum toxin for neurogenic detrusor overactivity as a result of spinal cord injury

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Onabotulinum 300 units
Drug: Injection of Onabotulinum toxin
multiple injections of Onabotulinum toxin into the detrusor muscle
Onabotulinum 200 units
Drug: Injection of Onabotulinum toxin
multiple injections of Onabotulinum toxin into the detrusor muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in detrusor pressure post-injection
Time Frame: within 3 months before injection; within 2 months after injection
bladder detrusor pressure during storage phase
within 3 months before injection; within 2 months after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximum bladder volume
Time Frame: within 3 months before injection; within 2 months after injection
within 3 months before injection; within 2 months after injection
bladder compliance
Time Frame: within 3 months before injection; within 2 months after injection
The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).
within 3 months before injection; within 2 months after injection
reflexive bladder volume
Time Frame: within 3 months before injection; within 2 months after injection
within 3 months before injection; within 2 months after injection
complications
Time Frame: within 2 months after injection
within 2 months after injection
presence of urinary incontinence
Time Frame: within 3 months before injection; within 2 months after injection
within 3 months before injection; within 2 months after injection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
lesion level
Time Frame: at the time of spinal cord injury
at the time of spinal cord injury
lesion severity
Time Frame: at the time of spinal cord injury
at the time of spinal cord injury
method of bladder evacuation
Time Frame: within 2 months after injection
evacuation by intermittent catheterization, reflex voiding, suprapubic catheter , electric stimulation
within 2 months after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Centre Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

July 31, 2019

Study Registration Dates

First Submitted

December 13, 2017

First Submitted That Met QC Criteria

December 22, 2017

First Posted (Actual)

January 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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