Trial · NCT01893138
Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
NCT01893138, Phase 3, Completed, Cook MyoSite; results first posted 2023-01-05
3 sourcestrials-2026-11-12-0.5.0
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Cite this record
ConductScience Library. Autologous Muscle Derived Cells for Female Urinary Sphincter Repair. Trials, record NCT01893138. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01893138
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Autologous Muscle Derived Cells for Female Urinary Sphincter Repair
- NCT number
- NCT01893138
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 311 participants, actual
- Lead sponsor
- Cook MyoSite
- Conditions
- Stress Urinary Incontinence
- Interventions
- Placebo, Iltamiocel
- First posted
- 2013-07-08
- Last updated
- 2023-01-05
- Results first posted
- 2023-01-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary | Baseline and 12 months | |
| Secondary | Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months | |
| Secondary | Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | Baseline and 12 months | |
| Secondary | Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months | |
| Other | Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency | Baseline and 12 months | Spearman's correlation used for analysis |
| Other | Treatment Durability at 24 Months | Baseline, 12 months, and 24 months after injection with iltamiocel | Treatment durability defined as iltamiocel-treated participants with reduction in stress incontinence episode frequency (SIEF) at 12 months who maintained that response at 24 months |
Source ClinicalTrials.gov
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary | Baseline and 12 months | All participants with baseline and 12 month 3 day diary data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months | All participants with baseline and 12 month 3 day diary data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | Baseline and 12 months | All participants with baseline and 12 month diary data | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months | Baseline and 12 months | All participants with baseline and 12 month 3 day diary data | stress leaks | MEAN |
| OTHER_PRE_SPECIFIED | Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency | Baseline and 12 months | All participants with baseline and 12 month diary data | correlation coefficient | NUMBER |
| OTHER_PRE_SPECIFIED | Treatment Durability at 24 Months | Baseline, 12 months, and 24 months after injection with iltamiocel | All participants who received iltamiocel treatment during the double-blind period and with 12-month and 24-month stress incontinence episode frequency (SIEF) diary data. Participants who received placebo treatment in the double-blind period are not included due to receiving iltamiocel treatment in the open-label period after unblinding or were exited from the study. | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only) | Baseline and 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| POST_HOC | Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months (Prior Surgery Participants Only) | Baseline and 12 months | Participants | COUNT_OF_PARTICIPANTS | |
| POST_HOC | Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only) | Baseline and 12 months | stress leaks | MEAN | |
| POST_HOC | Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency (Prior Surgery Participants Only) | Baseline and 12 months | All participants with prior surgery and baseline and 12 month diary data | correlation coefficient | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary | Iltamiocel | 103 | Participants | ||
| Participants With ≥ 50% Reduction in Stress Incontinence Episode Frequency From Baseline to 12 Months Post-treatment; as Assessed by 3 Day Diary | Placebo | 52 | Participants | ||
| Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | Iltamiocel | 73 | Participants | ||
| Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | Placebo | 30 | Participants | ||
| Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | Iltamiocel | 53 | Participants | ||
| Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | Placebo | 22 | Participants | ||
| Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months | Iltamiocel | -5.8 | Standard Deviation 11 | stress leaks | |
| Change in the Frequency of Stress Incontinence Episodes From Baseline at 12 Months | Placebo | -4.9 | Standard Deviation 13.5 | stress leaks | |
| Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency | Iltamiocel | Association of IQOL improvement with stress incontinence episode reduction at 12 months | -0.556 | correlation coefficient | |
| Association of Change in Quality of Life Scores With Change in Stress Incontinence Episode Frequency | Placebo | Association of IQOL improvement with stress incontinence episode reduction at 12 months | -0.456 | correlation coefficient |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-Blind Period | STARTED | Iltamiocel | 199 | |
| Double-Blind Period | STARTED | Placebo | 98 | |
| Double-Blind Period | Injection | Iltamiocel | 199 | |
| Double-Blind Period | Injection | Placebo | 98 | |
| Double-Blind Period | 1 Month Follow-Up | Iltamiocel | 199 | |
| Double-Blind Period | 1 Month Follow-Up | Placebo | 97 | |
| Double-Blind Period | 3 Month Follow-Up | Iltamiocel | 199 | |
| Double-Blind Period | 3 Month Follow-Up | Placebo | 97 | |
| Double-Blind Period | 6 Month Follow-Up | Iltamiocel | 198 | |
| Double-Blind Period | 6 Month Follow-Up | Placebo | 97 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events228
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | Iltamiocel - Double-Blind Period | 10 | 199 | 11 |
| other | Injection site pain | General disorders | Placebo - Double-Blind Period | 1 | 98 | 1 |
| other | Injection site pain | General disorders | Iltamiocel - Unblinded Period | 0 | 198 | 0 |
| other | Injection site pain | General disorders | Placebo Receiving Open Label Iltamiocel in Unblinded Period | 1 | 92 | 1 |
| other | Urinary tract infection | Infections and infestations | Iltamiocel - Double-Blind Period | 36 | 199 | 53 |
| other | Urinary tract infection | Infections and infestations | Placebo - Double-Blind Period | 14 | 98 | 19 |
| other | Urinary tract infection | Infections and infestations | Iltamiocel - Unblinded Period | 14 | 198 | 16 |
| other | Urinary tract infection | Infections and infestations | Placebo Receiving Open Label Iltamiocel in Unblinded Period | 10 | 92 | 12 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Iltamiocel - Double-Blind Period | 7 | 199 | 8 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo - Double-Blind Period | 5 | 98 | 6 |
1 to 10 of 228Source ClinicalTrials.gov
See all 228 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Iltamiocel - Double-Blind Period | 0 | 199 |
| Total, all-cause mortality | Placebo - Double-Blind Period | 0 | 98 |
| Total, all-cause mortality | Iltamiocel - Unblinded Period | 0 | 198 |
| Total, all-cause mortality | Placebo Receiving Open Label Iltamiocel in Unblinded Period | 0 | 92 |
| Total, other adverse events | Iltamiocel - Double-Blind Period | 84 | 199 |
| Total, other adverse events | Placebo - Double-Blind Period | 28 | 98 |
| Total, other adverse events | Iltamiocel - Unblinded Period | 21 | 198 |
| Total, other adverse events | Placebo Receiving Open Label Iltamiocel in Unblinded Period | 22 | 92 |
| Total, serious adverse events | Iltamiocel - Double-Blind Period | 11 | 199 |
| Total, serious adverse events | Placebo - Double-Blind Period | 9 | 98 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Iltamiocel vs Placebo: Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months (Prior Surgery Participants Only) | Trial comparisons |
| Iltamiocel vs Placebo: Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months (Prior Surgery Participants Only) | Trial comparisons |
| 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 |
| Iltamiocel vs Placebo: Participants With 0 or 1 Stress Incontinence Episodes Based on 3 Day Diary Records at 12 Months | Trial comparisons |
| Iltamiocel vs Placebo: Participants With at ≥ 75% Reduction in Stress Incontinence Episodes From Baseline at 12 Months | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01893138
GET https://conductscience.org/api/trials/v1/NCT01893138/results?page=2