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Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence

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ClinicalTrials.gov Identifier: NCT01226706
Recruitment Status : Completed
First Posted : October 22, 2010
Results First Posted : July 3, 2017
Last Update Posted : July 3, 2017
Sponsor:
Information provided by (Responsible Party):
Corrine Jabs, Saskatchewan Health Authority - Regina Area

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Urinary Urge Incontinence
Interventions Drug: Botulinum Toxins, Type A
Drug: Placebos
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Period Title: Overall Study
Started 10 11
Completed 10 11
Not Completed 0 0
Arm/Group Title Placebo Botulinum Toxin Type A Total
Hide Arm/Group Description

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Total of all reporting groups
Overall Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 11 participants 21 participants
63.8  (11.2) 63  (9.4) 63.38  (10.04)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
10
 100.0%
11
 100.0%
21
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 10 participants 11 participants 21 participants
10 11 21
1.Primary Outcome
Title Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up
Hide Description

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.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: mL
-97.5  (176.92) 64.1  (105.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments

A sample of 16 subjects per group was required to detect a mean difference of 50 mL in maximum capacity at cystoscopy between botulinum toxin and placebo at 90% power with a two-sided type I error of 5%.

Difference scores were computed for the primary outcome, which were then compared using the Wilcoxon- Mann-Whitney U test. This type of analysis was used to identify both between group differences and within group differences (over time) while using non-parametric statistics.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .016
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
2.Secondary Outcome
Title Change in Incontinence Episodes Between Baseline and 6 Week Follow-up
Hide Description Incontinence- involuntary leakage of urine
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of episodes
.50  (1.75) 3.00  (4.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.152
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
3.Secondary Outcome
Title Change in Incontinence Episodes Between Baseline and 3 Month Follow-up
Hide Description Incontinence- involuntary leakage of urine
Time Frame Baseline to 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of occurences
1.28  (2.43) 5.05  (5.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
4.Secondary Outcome
Title Change in Incontinence Episodes Between Baseline and 6 Month Follow-up
Hide Description Incontinence- involuntary leakage of urine
Time Frame Baseline to 6 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of episodes
-.39  (3.58) 4.09  (5.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
5.Secondary Outcome
Title Change in Incontinence Episodes Between Baseline and 9 Month Follow-up
Hide Description Incontinence- involuntary leakage of urine
Time Frame Baseline to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of occurences
-3.38  (2.43) NA [1]   (NA)
[1]
Data was not collected from this time period for the experimental group.
6.Secondary Outcome
Title Change in Incontinence Episodes Between Baseline and 12 Month Follow-up
Hide Description Incontinence- involuntary leakage of urine
Time Frame Baseline and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of occurences
-3.83  (2.06) -2.17  (5.02)
7.Secondary Outcome
Title Change in Incontinence Episodes Between Baseline and 24 Months Follow-up
Hide Description Incontinence- involuntary leakage of urine
Time Frame Baseline and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of occurences
-3.75  (1.81) -2.78  (7.55)
8.Secondary Outcome
Title Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up
Hide Description Frequency of daily urination
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
-0.50  (2.15) 2.14  (2.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
9.Secondary Outcome
Title Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up
Hide Description Frequency of daily urination
Time Frame Baseline to 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
0.89  (2.55) 3.32  (3.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
10.Secondary Outcome
Title Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up
Hide Description Frequency of daily urination
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
-0.22  (2.39) 2.73  (2.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
11.Secondary Outcome
Title Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up
Hide Description Frequency of daily urination
Time Frame Baseline to 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
-1.13  (1.69) NA [1]   (NA)
[1]
Data was not collected from this time period for the experimental group.
12.Secondary Outcome
Title Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up
Hide Description Frequency of daily urination
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
-1.61  (1.85) -1.67  (2.36)
13.Secondary Outcome
Title Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up
Hide Description Frequency of daily urination
Time Frame Baseline to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
-0.33  (3.92) -2.61  (2.85)
14.Secondary Outcome
Title Change in Number of Night Voids Between Baseline and 6 Week Follow-up
Hide Description Frequency of night voiding
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
0.31  (1.31) 0.77  (1.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.904
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
15.Secondary Outcome
Title Change in Number of Night Voids Between Baseline and 3 Month Follow-up
Hide Description Frequency of night voiding
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: Number of voids
0.06  (1.29) 1.36  (1.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.080
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
16.Secondary Outcome
Title Change in Number of Night Voids Between Baseline and 6 Month Follow-up
Hide Description Frequency of night voiding
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
0.33  (0.79) 1.32  (1.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.230
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
17.Secondary Outcome
Title Change in Number of Night Voids Between Baseline and 9 Month Follow-up
Hide Description Frequency of night voiding
Time Frame Baseline and 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: Number of voids
-1.13  (1.03) NA [1]   (NA)
[1]
Data was not collected from this time period for the experimental group.
18.Secondary Outcome
Title Change in Number of Night Voids Between Baseline and 12 Month Follow-up
Hide Description Frequency of night voiding
Time Frame Baseline to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
-0.94  (1.16) -1.28  (1.33)
19.Secondary Outcome
Title Change in Number of Night Voids Between Baseline and 24 Months Follow-up
Hide Description Frequency of night voiding
Time Frame Baseline and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: number of voids
-0.72  (1.25) -1.00  (1.35)
20.Secondary Outcome
Title Subjective Benefit Assessment at 6 Weeks
Hide Description

Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:

  1. dry (complete response),
  2. improvement (> 50% reduction in incontinence),
  3. partial response (≤ 50% reduction in incontinence),
  4. no response to treatment.
Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: score on a 4-point rating scale
3.4  (0.9) 2.4  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-2.1 to -0.2
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Subjective Benefit Assessment at 3 Months
Hide Description

Self assessed description of how well they believed the Botulinum Toxin type A was working. The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:

  1. dry (complete response),
  2. improvement (> 50% reduction in incontinence),
  3. partial response (≤ 50% reduction in incontinence),
  4. no response to treatment.
Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: score on a 4-point rating scale
3.2  (0.9) 1.9  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-2.1 to -0.5
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Subjective Benefit Assessment at 6 Months
Hide Description

Self assessed description of how well they believed the Botulinum Toxin type A was working.The patients’ subjective assessment of the treatment’s efficacy was obtained verbally using a four-point rating scale. Rating options were:

  1. dry (complete response),
  2. improvement (> 50% reduction in incontinence),
  3. partial response (≤ 50% reduction in incontinence),
  4. no response to treatment.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: score on a 4-point rating scale
2.8  (0.9) 1.6  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.2
Confidence Interval (2-Sided) 95%
-2.0 to -0.4
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up
Hide Description

Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.

Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.

Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
.00  (14.02) 27.27  (41.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.173
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
24.Secondary Outcome
Title Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up
Hide Description

Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.

Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.

Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
4.29  (15.30) 35.35  (41.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
25.Secondary Outcome
Title Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up
Hide Description

Disease specific validated quality of life measure. Health-related quality of life measures for women with urinary incontinence.

Incontinences Impact Questionnaire – 7 (IIQ-7) The IIQ-7 is 7-point scale used to rate a patients’ life and the affect of accidental urine loss on activities, relationships, and feelings. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
3.81  (33.95) 34.63  (36.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.051
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
26.Secondary Outcome
Title Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up
Hide Description

Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.

Urogenital Distress Inventory – 6 (UDI-6) The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.

Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
6.11  (15.37) 17.68  (30.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
27.Secondary Outcome
Title Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up
Hide Description

Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.

The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.

Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
15.33  (14.44) 32.32  (19.69)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
28.Secondary Outcome
Title Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up
Hide Description

Disease specific quality of life measure. Health-related quality of life measures for women with urinary incontinence.

The UDI-6 is a 6-point scale that asks patients to respond to questions rating whether they experience and how much they are bothered by UUI. Item responses are assigned values of 0 for “not at all,” 1 for “slightly,” 2 for “moderately,” and 3 for “greatly.” The average score of items responded to is calculated. Higher scores reflect greater distress associated with symptoms. The average, which ranges from 0 to 3, is multiplied by 33 1/3 to put scores on a scale of 0 to 100.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
11.11  (23.57) 28.48  (17.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.132
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
29.Secondary Outcome
Title Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks
Hide Description

Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.

Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems.

Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
.20  (.79) 1.45  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.085
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
30.Secondary Outcome
Title Change in Patient Perception of Bladder Condition From Baseline to 3 Months
Hide Description

Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.

Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems.

Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
.50  (1.27) 1.82  (1.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.099
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
31.Secondary Outcome
Title Change in Patient Perception of Bladder Condition From Baseline to 6 Months
Hide Description

Disease specific validated quality of life measures. A single-item global measure for patients with overactive bladder.

Patient Perception of Bladder Condition (PPBC) The PPBC is a single-item, 6-point scale that asks patients to rate their subjective impression of their current bladder problems. It has been shown to have concurrent and discriminant validity as well as responsiveness to treatment. Patients are asked to rate their perceived bladder condition on a 6-point scale ranging from 1 “no problems at all”, 2 "some very minor problems". 3 "some minor problems", 4"(some) moderate problems", 5 "severe problems", and 6 “many severe problems”. A higher score indicates a more negative impression of current bladder problems.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
.50  (1.43) 1.55  (1.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.132
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
32.Secondary Outcome
Title Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks
Hide Description

A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.

Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges.

Time Frame Baseline to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
1.00  (0.88) 1.09  (1.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
33.Secondary Outcome
Title Change in Indevus Urgency Severity Scale From Baseline to 3 Months
Hide Description

A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.

Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges.

Time Frame Baseline to 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
0.67  (1.0) 1.36  (1.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.230
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
34.Secondary Outcome
Title Change in Indevus Urgency Severity Scale From Baseline to 6 Months
Hide Description

A disease specific quality of life measure. A self reported measure that assesses urinary urgency severity associated with overactive bladder.

Indevus Urgency Severity Scale (IIUS) The IIUS is a single item scale designed to describe urinary urges. The scale is rated through the patient’s urge: none (0 points), mild (1), moderate (2) and severe (3). A higher score represents more urinary urges.

Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:
normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: summary score
0.60  (0.97) 1.09  (.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.314
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
35.Secondary Outcome
Title 24 Hour Pad Weight (gm) at 3 Months
Hide Description weight of pad (in gm) worn for 24 hours to detect urine loss
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: gm
413.30  (558.82) 141.18  (301.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
36.Secondary Outcome
Title 24 Hour Pad Weight (gm) at 9 Months
Hide Description weight of pad (in gm) worn for 24 hours to detect urine loss
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Mean (Standard Deviation)
Unit of Measure: gm
64.11  (145.36) 110.63  (277.01)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Botulinum Toxin Type A
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.888
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments A Bonferroni correction (0.05/n) was used for multiple comparisons
37.Secondary Outcome
Title Frequency of Urinary Tract Infections From Baseline to 6 Months
Hide Description Frequency of urinary tract infections from baseline to 6 month-follow-up
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Measure Type: Number
Unit of Measure: number of occurences
4 6
38.Secondary Outcome
Title Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up
Hide Description Frequency of participants needing self-catheterization from baseline to 6 month follow-up.
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Measure Type: Number
Unit of Measure: Participants
0 1
39.Secondary Outcome
Title Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months
Hide Description Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up
Time Frame Baseline to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description:

Placebo injected into the detrusor at Day 1,

Placebo: Placebo injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.

Botulinum toxin Type A 100U injected into the detrusor at Day 1

botulinum toxin Type A: Botulinum toxin Type A 100U injected into the detrusor at Day 1

Overall Number of Participants Analyzed 10 11
Measure Type: Count of Participants
Unit of Measure: Participants
4
  40.0%
6
  54.5%
Time Frame Adverse events were monitored from baseline up to 12 months after intervention (at 4-6 weeks, 3 months, 6 months, 9 months and 12 months).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Botulinum Toxin Type A
Hide Arm/Group Description normal saline injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy Botulinum toxin Type A 100U injected into the detrusor in 5 sites on each side of the bladder (1 mL at each site) during cystoscopy
All-Cause Mortality
Placebo Botulinum Toxin Type A
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Botulinum Toxin Type A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/11 (9.09%)    
Cardiac disorders     
Perioperative Cardiac Event (Takotsubo syndrome) *  0/10 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Botulinum Toxin Type A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/10 (30.00%)      5/11 (45.45%)    
Gastrointestinal disorders     
Constipation *  0/10 (0.00%)  1/11 (9.09%) 
General disorders     
Pain/Discomfort *  2/10 (20.00%)  3/11 (27.27%) 
Infections and infestations     
Hematuria *  1/10 (10.00%)  1/11 (9.09%) 
*
Indicates events were collected by non-systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Corrine Jabs
Organization: Gynecology, Regina Qu'Appelle Health Region
Phone: (306) 586-3120
EMail: corrinejabs@hotmail.com
Publications:
Layout table for additonal information
Responsible Party: Corrine Jabs, Saskatchewan Health Authority - Regina Area
ClinicalTrials.gov Identifier: NCT01226706     History of Changes
Other Study ID Numbers: REB-08-04
120486 ( Registry Identifier: Health Canada )
First Submitted: October 18, 2010
First Posted: October 22, 2010
Results First Submitted: August 4, 2015
Results First Posted: July 3, 2017
Last Update Posted: July 3, 2017