Efficacy of Two Onabotulinum Toxin Doses | NCT03388086

Studies
Efficacy of Two Onabotulinum Toxin Doses

NCT03388086

Sponsor

Swiss Paraplegic Research, Nottwil

Status

Completed

Last Update Posted

Aug 6, 2019Actual

Enrollment

56Actual

Phase

Not provided

Conditions

Neurogenic Bladder
Overactive Detrusor

Interventions

Injection of Onabotulinum toxin

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

Jul 31, 2019Actual

First Submitted Date

Dec 13, 2017

First Submission Date that Met QC Criteria

Dec 22, 2017

First Posted Date

Jan 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2019

Last Update Posted Date

Aug 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Onabotulinum 300 units			Drug: Injection of Onabotulinum toxin
Onabotulinum 200 units			Drug: Injection of Onabotulinum toxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Injection of Onabotulinum toxin	Drug	multiple injections of Onabotulinum toxin into the detrusor muscle	Onabotulinum 200 units Onabotulinum 300 units

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
lesion level		at the time of spinal cord injury
lesion severity		at the time of spinal cord injury
method of bladder evacuation

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Swiss Paraplegic Centre		Nottwil	Canton of Lucerne	6207	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D001750	Urinary Bladder, Neurogenic
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases

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Browse Branches

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