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Completed

NCT Number: NCT03388086

Efficacy of Two Onabotulinum Toxin Doses

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.

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Key information

Conditions

Neurogenic Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Overactive Detrusor Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Injection of Onabotulinum toxin

Drug

multiple injections of Onabotulinum toxin into the detrusor muscle

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2018
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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