ClinicalTrials.gg
CompletedNCT03388086Updated Aug 6, 2019

Efficacy of Two Onabotulinum Toxin Doses

An observational study in Neurogenic Bladder and Overactive Detrusor, sponsored by Swiss Paraplegic Research, Nottwil. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-08-06.

Sponsored by Swiss Paraplegic Research, Nottwil · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
56
Ages
18 Years to 99 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies in Urinary Bladder, Neurogenic with a site in Switzerland — 2 open to participants now, 2 under way, 1 of them phase 3. Urinary Bladder, Neurogenic · Switzerland.

Started
2018
the only one that year
Observational
7 of 15
1 open now
Registered
11th of 15
by date
Lead sponsor
4 of 15
Swiss Paraplegic Research, Nottwil

Among the 15 studies in Urinary Bladder, Neurogenic with a site in Switzerland, this one is the only one that started in 2018, is one of 7 observational ones, and was the 11th registered.

Urinary Bladder, Neurogenic

189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.

Browse Urinary Bladder, Neurogenic studies →

Open to participants now

2 of the 15 studies in Urinary Bladder, Neurogenic with a site in Switzerland are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 26 Urinary Bladder, Neurogenic studies recruiting now, 12 (46%) set no upper age limit and 9 (35%) stop at 75 or younger; 7 take children under 18; 1 take healthy volunteers.

This study: 18 Years to 99 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Neurogenic Bladder
  • Overactive Detrusor
04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • missing urodynamic values before or after Onabotulinum toxin injections
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
56 participants (actual)
Patient registry
No

Groups and cohorts

  • Onabotulinum 300 units

    Drug: Injection of Onabotulinum toxin

  • Onabotulinum 200 units

    Drug: Injection of Onabotulinum toxin

Interventions

  • DrugInjection of Onabotulinum toxin

    multiple injections of Onabotulinum toxin into the detrusor muscle

06

What researchers measure

Primary outcomes

  1. change in detrusor pressure post-injection

    bladder detrusor pressure during storage phase

    Time frame: within 3 months before injection; within 2 months after injection

Secondary outcomes

  1. maximum bladder volume

    Time frame: within 3 months before injection; within 2 months after injection

  2. bladder compliance

    The relationship between a change in bladder volume and the change in detrusor pressure (ΔDV/ΔDP).

    Time frame: within 3 months before injection; within 2 months after injection

  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

    evacuation by intermittent catheterization, reflex voiding, suprapubic catheter , electric stimulation

    Time frame: within 2 months after injection

07

Study locations

1 site
  • Swiss Paraplegic Centre
    Nottwil, LU 6207, Switzerland
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Apr 2019, 14 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 13, 2017
First posted
Jan 2, 2018
StartActual
Feb 1, 2018
Primary completionActual
Apr 30, 2019
CompletionActual
Jul 31, 2019
Last update
Aug 6, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03388086
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Jan 2, 2018
Start date
Feb 1, 2018
Primary completion
Apr 30, 2019
Completion
Jul 31, 2019
Last update
Aug 6, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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