Comparison · NCT01893138-5aadeaa5
Iltamiocel vs Placebo: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
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. Iltamiocel vs Placebo: Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary. Trial comparisons, record NCT01893138-5aadeaa5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01893138-5aadeaa5
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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 | 0.52 | 0.451 | 0.589 | wilson | |
| Risk in group 2 | 0.536 | 0.437 | 0.632 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0159 | -0.134 | 0.104 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.97 | 0.772 | 1.22 | log | |
| Odds ratio, group 1 over group 2 | 0.938 | 0.577 | 1.53 | log | |
| Number needed to treat, for one fewer participant with the outcome on Iltamiocel than on Placebo | 63 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Iltamiocel | AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intraurethral injection of 150 x 10\^6 cells. | 103 | 198 | OG000 |
| Group 2 | Placebo | Placebo control is the vehicle solution used for the study product. Single intraurethral injection of vehicle control. | 52 | 97 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary
- Description
- Time frame
- Baseline and 12 months
- Population
- All participants with baseline and 12 month 3 day diary data
Source ClinicalTrials.gov
Trial
- Title
- Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
- NCT number
- NCT01893138
- Phases
- PHASE3
- Conditions
- Stress Urinary Incontinence
- Interventions
- Placebo, Iltamiocel
- Lead sponsor
- Cook MyoSite
- Results first posted
- 2023-01-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01893138?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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