NCT03388086

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

December 13, 2017

Last Update Submit

August 5, 2019

Conditions

Neurogenic BladderOveractive Detrusor

Outcome Measures

Primary Outcomes (1)

  • change in detrusor pressure post-injection

    bladder detrusor pressure during storage phase

    within 3 months before injection; within 2 months after injection

Secondary Outcomes (5)

  • maximum bladder volume

    within 3 months before injection; within 2 months after injection

  • bladder compliance

    within 3 months before injection; within 2 months after injection

  • reflexive bladder volume

    within 3 months before injection; within 2 months after injection

  • complications

    within 2 months after injection

  • presence of urinary incontinence

    within 3 months before injection; within 2 months after injection

Other Outcomes (3)

  • lesion level

    at the time of spinal cord injury

  • lesion severity

    at the time of spinal cord injury

  • method of bladder evacuation

    within 2 months after injection

Study Arms (2)

Onabotulinum 300 units

Drug: Injection of Onabotulinum toxin

Onabotulinum 200 units

Drug: Injection of Onabotulinum toxin

Interventions

Injection of Onabotulinum toxinDRUG

multiple injections of Onabotulinum toxin into the detrusor muscle

Onabotulinum 200 unitsOnabotulinum 300 units

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • missing urodynamic values before or after Onabotulinum toxin injections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicUrinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLower Urinary Tract SymptomsUrological Manifestations

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2017

First Posted

January 2, 2018

Study Start

February 1, 2018

Primary Completion

April 30, 2019

Study Completion

July 31, 2019

Last Updated

August 6, 2019

Record last verified: 2019-08

Locations

CH(1)