Trial · NCT01089751
Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
NCT01089751, Phase 4, Completed, Allergan; results first posted 2013-09-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily. Trials, record NCT01089751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01089751
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Sanctura XR (Trospium Chloride) for Reducing Overactive Bladder Symptoms in Female Subjects Refractory to Detrol LA (Tolterodine Tartrate Extended Release) Daily
- NCT number
- NCT01089751
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 322 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Overactive Bladder
- Interventions
- trospium chloride, placebo
- First posted
- 2010-03-19
- Last updated
- 2013-09-26
- Results first posted
- 2013-09-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Continent (PPC) | Week 14 | PPC is the percentage of patients with complete continence (without any urgency urinary incontinence episodes) during the 3-day bladder diary period associated with the Week 14 visit. |
| Secondary | Change From Baseline in Continent Days Per Week (CDW) | Baseline, Week 14 | Continent Days per Week is the average of the number of times an individual has no incontinence episodes in a day within the 3-day collection period calculated as 7 x (number of dry days within the 3-day diary period) divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A positive change from Baseline (more continent/fewer incontinent days per week ) indicated improvement. |
| Secondary | Change From Baseline in Nocturic Toilet Voids | Baseline, Week 14 | A nocturic (nighttime) toilet void is identified if the patient marks "Yes" for both Toilet Voiding and Sleep Interruption in the 3-day bladder diary. The daily average number of nocturic toilet voids is obtained as the sum of all nighttime toilet voids over the 3-day bladder diary period divided by number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer nocturic toilet voids) indicated improvement. |
| Secondary | Change From Baseline in Urgency-Related Toilet Voids | Baseline, Week 14 | Urgency-related toilet void (or urinary urgency) is identified if the patient marks "Yes" for both Urgency Association Void and Toilet Voiding in the 3-day bladder diary. The daily average number of urgency-related voids is calculated as the sum of all urgency episodes over the 3-day bladder diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline (fewer urgency related toilet voids) indicated improvement. |
| Secondary | Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS) | Baseline, Week 14 | The OAB-SCS is derived from the 3-day bladder diary which includes: 1) 24-hour voiding frequency; 2) the Indevus Urgency Severity Scale (IUSS) Score (0=no urgency, 1=aware of urgency but is tolerable, 2=urgency discomfort interferes with activities/tasks, 3=extreme urgency discomfort that abruptly stops activities/tasks associated with each toilet void); and 3) the frequency of Urgency Urinary Incontinence episodes. Each toilet void is then assigned a point value from 1 (IUSS Score=0) to 5 (UUI episode not associated with a toilet void). The daily average OAB-SCS is then calculated based on the diary entries and assigned point values. The lowest possible daily average OAB-SCS is 0 (corresponding to no urgency in every void). There is no upper limit since the score is based on the number of voids per day. Scores \<= 30 indicate mild OAB, scores \> 30 to 39 indicate moderate OAB, and scores \>= 40 indicate severe OAB. A negative change from Baseline indicated improvement. |
| Secondary | Change From Baseline in Voided Volume | Baseline, Week 14 | Average volume of urine voided per toilet void is calculated by total volume collected in a 24-hour diary period divided by the number of individual entries of volume voided in that period. A positive change from Baseline (greater volume voided) indicated improvement. A negative change from Baseline (less volume voided) indicated a worsening. |
| Secondary | Change From Baseline in Urgency Severity | Baseline, Week 14 | The urgency severity per toilet void is based on the Indevus Urgency Severity Scale (IUSS). The patient recorded urinary urgency severity in a 3-day bladder diary using a 4-point scale: 0=None-no urgency (best), 1=Slight-aware of urgency but is tolerable, 2=Moderate-urgency discomfort interferes with activities/tasks, 3=Severe-extreme urgency discomfort that abruptly stops activities/tasks (worst). Urgency Severity is calculated as the sum of all IUSS scores during the 3-day diary period divided by the number of toilet voids recorded during that period. A negative change from Baseline indicated improvement. |
| Secondary | Change From Baseline in Urgency Urinary Incontinence (UUI) | Baseline, Week 14 | Urgency urinary incontinence is identified if the patient marks "Yes" for both Accidental Leakage and Urgency Associated Void in the 3-day bladder diary, and the Urgency Severity score is ≥ 1. Average daily episodes of UUI is calculated as the sum of all UUI episodes over 3-day diary period divided by the number of valid diary days with at least one valid bladder diary entry during the 3-day period. A negative change from Baseline indicated improvement. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Continent (PPC) | Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Continent Days Per Week (CDW) | Baseline, Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | Continent days per week | MEAN |
| SECONDARY | Change From Baseline in Nocturic Toilet Voids | Baseline, Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | Nocturic toilet void | MEAN |
| SECONDARY | Change From Baseline in Urgency-Related Toilet Voids | Baseline, Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | Toilet void | MEAN |
| SECONDARY | Change From Baseline in Daily Average Overactive Bladder-Symptom Composite Score (OAB-SCS) | Baseline, Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Voided Volume | Baseline, Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | cubic centimeters (cc) | MEAN |
| SECONDARY | Change From Baseline in Urgency Severity | Baseline, Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Urgency Urinary Incontinence (UUI) | Baseline, Week 14 | Modified intent-to-treat population included all randomized participants who were incontinent at Baseline with at least one urinary episode marked Yes for both Accidental leakage and Urgency associated void, and an Urgency severity rating ≥ 1 in the bladder diary. | UUI episodes | MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Continent (PPC) | Sanctura XR® | 34.6 | Percentage of participants | ||
| Percentage of Patients Continent (PPC) | Placebo | 17.1 | Percentage of participants | ||
| Change From Baseline in Continent Days Per Week (CDW) | Sanctura XR® | Baseline | 0.8 | Standard Deviation 1.46 | Continent days per week |
| Change From Baseline in Continent Days Per Week (CDW) | Placebo | Baseline | 1.0 | Standard Deviation 1.52 | Continent days per week |
| Change From Baseline in Continent Days Per Week (CDW) | Sanctura XR® | Change from Baseline at Week 14 | 2.6 | Standard Deviation 2.96 | Continent days per week |
| Change From Baseline in Continent Days Per Week (CDW) | Placebo | Change from Baseline at Week 14 | 1.3 | Standard Deviation 2.73 | Continent days per week |
| Change From Baseline in Nocturic Toilet Voids | Sanctura XR® | Baseline | 2.2 | Standard Deviation 1.40 | Nocturic toilet void |
| Change From Baseline in Nocturic Toilet Voids | Placebo | Baseline | 2.3 | Standard Deviation 1.41 | Nocturic toilet void |
| Change From Baseline in Nocturic Toilet Voids | Sanctura XR® | Change from Baseline at Week 14 | -0.6 | Standard Deviation 1.51 | Nocturic toilet void |
| Change From Baseline in Nocturic Toilet Voids | Placebo | Change from Baseline at Week 14 | -0.3 | Standard Deviation 1.42 | Nocturic toilet void |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sanctura XR® | 163 | |
| Overall Study | STARTED | Placebo | 159 | |
| Overall Study | COMPLETED | Sanctura XR® | 129 | |
| Overall Study | COMPLETED | Placebo | 132 | |
| Overall Study | NOT COMPLETED | Sanctura XR® | 34 | |
| Overall Study | NOT COMPLETED | Placebo | 27 |
Source ClinicalTrials.gov
Adverse events18
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 | Dry mouth | Gastrointestinal disorders | Sanctura XR® | 11 | 162 | |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 6 | 158 | |
| other | Constipation | Gastrointestinal disorders | Sanctura XR® | 9 | 162 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 2 | 158 | |
| serious | Anaemia | Blood and lymphatic system disorders | Sanctura XR® | 1 | 162 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 158 | |
| serious | Pericardial effusion | Cardiac disorders | Sanctura XR® | 0 | 162 | |
| serious | Pericardial effusion | Cardiac disorders | Placebo | 1 | 158 | |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | Sanctura XR® | 1 | 162 | |
| serious | Gastrooesophageal reflux disease | Gastrointestinal disorders | Placebo | 0 | 158 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sanctura XR® | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Sanctura XR® | 20 | 162 |
| Total, other adverse events | Placebo | 8 | 158 |
| Total, serious adverse events | Sanctura XR® | 2 | 162 |
| Total, serious adverse events | Placebo | 3 | 158 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Sanctura XR® vs Placebo: serious adverse events |
Source 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/NCT01089751
GET https://conductscience.org/api/trials/v1/NCT01089751/results?page=2