Trial · NCT01226706
Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence
NCT01226706, Not applicable, Completed, Saskatchewan Health Authority - Regina Area; results first posted 2017-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence. Trials, record NCT01226706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01226706
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence
- NCT number
- NCT01226706
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 21 participants, actual
- Lead sponsor
- Saskatchewan Health Authority - Regina Area
- Conditions
- Urinary Urge Incontinence
- Interventions
- Botulinum Toxins, Type A, Placebos
- First posted
- 2010-10-22
- Last updated
- 2017-07-03
- Results first posted
- 2017-07-03
- Limitations and caveats
Poor recruitment. Recruitment slowed significantly when newer anticholinergic medications became available. Those who were previously eligible for the study had darifenacin and solifenacin to try before considering botulinum toxin treatment.
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up | Baseline to 6 months | Cystoscopy is a test performed with a cystoscope, a narrow tube with a tiny camera at its tip, inserted into the urethra and bladder to see the inside of the bladder and urethra. Maximum bladder capacity--the amount of liquid or gas the bladder can hold under anesthesia. Without anesthesia, capacity is limited by either pain or a severe urge to urinate. |
| Secondary | Change in Incontinence Episodes Between Baseline and 6 Week Follow-up | Baseline to 6 weeks | Incontinence- involuntary leakage of urine |
| Secondary | Change in Incontinence Episodes Between Baseline and 3 Month Follow-up | Baseline to 3 month | Incontinence- involuntary leakage of urine |
| Secondary | Change in Incontinence Episodes Between Baseline and 6 Month Follow-up | Baseline to 6 month | Incontinence- involuntary leakage of urine |
| Secondary | Change in Incontinence Episodes Between Baseline and 9 Month Follow-up | Baseline to 9 months | Incontinence- involuntary leakage of urine |
| Secondary | Change in Incontinence Episodes Between Baseline and 12 Month Follow-up | Baseline and 12 months | Incontinence- involuntary leakage of urine |
| Secondary | Change in Incontinence Episodes Between Baseline and 24 Months Follow-up | Baseline and 24 months | Incontinence- involuntary leakage of urine |
| Secondary | Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up | Baseline to 6 weeks | Frequency of daily urination |
| Secondary | Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up | Baseline to 3 month | Frequency of daily urination |
| Secondary | Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up | Baseline to 6 months | Frequency of daily urination |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up | Baseline to 6 months | mL | MEAN | |
| SECONDARY | Change in Incontinence Episodes Between Baseline and 6 Week Follow-up | Baseline to 6 weeks | number of episodes | MEAN | |
| SECONDARY | Change in Incontinence Episodes Between Baseline and 3 Month Follow-up | Baseline to 3 month | number of occurences | MEAN | |
| SECONDARY | Change in Incontinence Episodes Between Baseline and 6 Month Follow-up | Baseline to 6 month | number of episodes | MEAN | |
| SECONDARY | Change in Incontinence Episodes Between Baseline and 9 Month Follow-up | Baseline to 9 months | number of occurences | MEAN | |
| SECONDARY | Change in Incontinence Episodes Between Baseline and 12 Month Follow-up | Baseline and 12 months | number of occurences | MEAN | |
| SECONDARY | Change in Incontinence Episodes Between Baseline and 24 Months Follow-up | Baseline and 24 months | number of occurences | MEAN | |
| SECONDARY | Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up | Baseline to 6 weeks | number of voids | MEAN | |
| SECONDARY | Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up | Baseline to 3 month | number of voids | MEAN | |
| SECONDARY | Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up | Baseline to 6 months | number of voids | MEAN |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up | Placebo | -97.5 | Standard Deviation 176.92 | mL | |
| Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up | Botulinum Toxin Type A | 64.1 | Standard Deviation 105.16 | mL | |
| Change in Incontinence Episodes Between Baseline and 6 Week Follow-up | Placebo | .50 | Standard Deviation 1.75 | number of episodes | |
| Change in Incontinence Episodes Between Baseline and 6 Week Follow-up | Botulinum Toxin Type A | 3.00 | Standard Deviation 4.90 | number of episodes | |
| Change in Incontinence Episodes Between Baseline and 3 Month Follow-up | Placebo | 1.28 | Standard Deviation 2.43 | number of occurences | |
| Change in Incontinence Episodes Between Baseline and 3 Month Follow-up | Botulinum Toxin Type A | 5.05 | Standard Deviation 5.06 | number of occurences | |
| Change in Incontinence Episodes Between Baseline and 6 Month Follow-up | Placebo | -.39 | Standard Deviation 3.58 | number of episodes | |
| Change in Incontinence Episodes Between Baseline and 6 Month Follow-up | Botulinum Toxin Type A | 4.09 | Standard Deviation 5.29 | number of episodes | |
| Change in Incontinence Episodes Between Baseline and 9 Month Follow-up | Placebo | -3.38 | Standard Deviation 2.43 | number of occurences | |
| Change in Incontinence Episodes Between Baseline and 9 Month Follow-up | Botulinum Toxin Type A | NA | Standard Deviation NA | number of occurences |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | STARTED | Botulinum Toxin Type A | 11 | |
| Overall Study | COMPLETED | Placebo | 10 | |
| Overall Study | COMPLETED | Botulinum Toxin Type A | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | Botulinum Toxin Type A | 0 |
Source ClinicalTrials.gov
Adverse events8
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 | Hematuria | Infections and infestations | Placebo | 1 | 10 | |
| other | Hematuria | Infections and infestations | Botulinum Toxin Type A | 1 | 11 | |
| other | Pain/Discomfort | General disorders | Placebo | 2 | 10 | |
| other | Pain/Discomfort | General disorders | Botulinum Toxin Type A | 3 | 11 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 0 | 10 | |
| other | Constipation | Gastrointestinal disorders | Botulinum Toxin Type A | 1 | 11 | |
| serious | Perioperative Cardiac Event (Takotsubo syndrome) | Cardiac disorders | Placebo | 0 | 10 | 0 |
| serious | Perioperative Cardiac Event (Takotsubo syndrome) | Cardiac disorders | Botulinum Toxin Type A | 1 | 11 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Botulinum Toxin Type A | ||
| Total, other adverse events | Placebo | 3 | 10 |
| Total, other adverse events | Botulinum Toxin Type A | 5 | 11 |
| Total, serious adverse events | Placebo | 0 | 10 |
| Total, serious adverse events | Botulinum Toxin Type A | 1 | 11 |
Source ClinicalTrials.gov
Papers12
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Botulinum Toxin Type A vs Placebo: Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months | Trial comparisons |
| Botulinum Toxin Type A vs Placebo: Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up | Trial comparisons |
| Botulinum Toxin Type A vs Placebo: serious adverse events | 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/NCT01226706
GET https://conductscience.org/api/trials/v1/NCT01226706/registered?page=2