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Efficacy of Two Onabotulinum Toxin Doses

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ClinicalTrials.gov Identifier: NCT03388086
Recruitment Status : Enrolling by invitation
First Posted : January 2, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

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.

Condition or disease Intervention/treatment
Neurogenic Bladder Overactive Detrusor Drug: Injection of Onabotulinum toxin

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparing the Efficacy of Two Doses of Onabotulinum Toxin for the Treatment of Neurogenic Detrusor Overactivity - a Retrospective Cohort Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : June 30, 2019

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




Primary Outcome Measures :
  1. change in detrusor pressure post-injection [ Time Frame: within 3 months before injection; within 2 months after injection ]
    bladder detrusor pressure during storage phase


Secondary Outcome Measures :
  1. maximum bladder volume [ Time Frame: within 3 months before injection; within 2 months after injection ]
  2. 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).

  3. reflexive bladder volume [ Time Frame: within 3 months before injection; within 2 months after injection ]
  4. complications [ Time Frame: within 2 months after injection ]
  5. presence of urinary incontinence [ Time Frame: within 3 months before injection; within 2 months after injection ]

Other Outcome Measures:
  1. lesion level [ Time Frame: at the time of spinal cord injury ]
  2. lesion severity [ Time Frame: at the time of spinal cord injury ]
  3. method of bladder evacuation [ Time Frame: within 2 months after injection ]
    evacuation by intermittent catheterization, reflex voiding, suprapubic catheter , electric stimulation



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients treated with Onabotulinum toxin for neurogenic detrusor overactivity as a result of spinal cord injury
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03388086


Locations
Switzerland
Swiss Paraplegic Centre
Nottwil, LU, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT03388086     History of Changes
Other Study ID Numbers: 2017-17
First Posted: January 2, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms
Lower Urinary Tract Symptoms
Urological Manifestations