Comparison · NCT01166438-sae
Botox A vs Standardized Anticholinergic Regimen: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Botox A vs Standardized Anticholinergic Regimen: serious adverse events. Trial comparisons, record NCT01166438-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01166438-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0413 | 0.0178 | 0.0931 | wilson | |
| Risk in group 2 | 0.0556 | 0.0272 | 0.11 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0142 | -0.0738 | 0.0448 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.744 | 0.243 | 2.28 | log | |
| Odds ratio, group 1 over group 2 | 0.733 | 0.226 | 2.37 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Botox A than on Standardized Anticholinergic Regimen | 70.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Botox A | A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets~Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices. | 5 | 121 | EG000 |
| Group 2 | Standardized Anticholinergic Regimen | A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. Dose escalation or drug change will be based exclusively on the result of the Patient Global Symptom Control Rating. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study. | 7 | 126 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Anticholinergic vs. Botox Comparison Study
- NCT number
- NCT01166438
- Phases
- PHASE3
- Conditions
- Urge Urinary Incontinence, Overactive Bladder
- Interventions
- Botulinum toxin A (Botox A®), Solifenacin 5mg, Solifenacin 10mg, Trospium chloride
- Lead sponsor
- NICHD Pelvic Floor Disorders Network
- Results first posted
- 2017-12-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01166438?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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