Trial Outcomes & Findings for Efficacy of Botulinum Toxin Type A for the Treatment of Non-neurogenic Urinary Urge Incontinence (NCT NCT01226706)

NCT ID: NCT01226706

Last Updated: 2017-07-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2017-07-03

Participant Flow

Participant milestones

Measure	Placebo 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 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 Study STARTED	10	11
Overall Study COMPLETED	10	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Placebo n=10 Participants 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 n=11 Participants 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 n=21 Participants Total of all reporting groups
Age, Continuous	63.8 years STANDARD_DEVIATION 11.2 • n=5 Participants	63 years STANDARD_DEVIATION 9.4 • n=7 Participants	63.38 years STANDARD_DEVIATION 10.04 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Maximum Capacity at Cystoscopy Between Baseline and 6 Month Follow-up	-97.5 mL Standard Deviation 176.92	64.1 mL Standard Deviation 105.16

SECONDARY outcome

Timeframe: Baseline to 6 weeks

Incontinence- involuntary leakage of urine

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Episodes Between Baseline and 6 Week Follow-up	.50 number of episodes Standard Deviation 1.75	3.00 number of episodes Standard Deviation 4.90

SECONDARY outcome

Timeframe: Baseline to 3 month

Incontinence- involuntary leakage of urine

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Episodes Between Baseline and 3 Month Follow-up	1.28 number of occurences Standard Deviation 2.43	5.05 number of occurences Standard Deviation 5.06

SECONDARY outcome

Timeframe: Baseline to 6 month

Incontinence- involuntary leakage of urine

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Episodes Between Baseline and 6 Month Follow-up	-.39 number of episodes Standard Deviation 3.58	4.09 number of episodes Standard Deviation 5.29

SECONDARY outcome

Timeframe: Baseline to 9 months

Incontinence- involuntary leakage of urine

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Episodes Between Baseline and 9 Month Follow-up	-3.38 number of occurences Standard Deviation 2.43	NA number of occurences Standard Deviation NA Data was not collected from this time period for the experimental group.

SECONDARY outcome

Timeframe: Baseline and 12 months

Incontinence- involuntary leakage of urine

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Episodes Between Baseline and 12 Month Follow-up	-3.83 number of occurences Standard Deviation 2.06	-2.17 number of occurences Standard Deviation 5.02

SECONDARY outcome

Timeframe: Baseline and 24 months

Incontinence- involuntary leakage of urine

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Episodes Between Baseline and 24 Months Follow-up	-3.75 number of occurences Standard Deviation 1.81	-2.78 number of occurences Standard Deviation 7.55

SECONDARY outcome

Timeframe: Baseline to 6 weeks

Frequency of daily urination

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Daytime Voids Between Baseline and 6 Week Follow-up	-0.50 number of voids Standard Deviation 2.15	2.14 number of voids Standard Deviation 2.55

SECONDARY outcome

Timeframe: Baseline to 3 month

Frequency of daily urination

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Daytime Voids Between Baseline and 3 Month Follow-up	0.89 number of voids Standard Deviation 2.55	3.32 number of voids Standard Deviation 3.09

SECONDARY outcome

Timeframe: Baseline to 6 months

Frequency of daily urination

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Daytime Voids Between Baseline and 6 Month Follow-up	-0.22 number of voids Standard Deviation 2.39	2.73 number of voids Standard Deviation 2.93

SECONDARY outcome

Timeframe: Baseline to 9 months

Frequency of daily urination

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Daytime Voids Between Baseline and 9 Month Follow-up	-1.13 number of voids Standard Deviation 1.69	NA number of voids Standard Deviation NA Data was not collected from this time period for the experimental group.

SECONDARY outcome

Timeframe: Baseline to 12 months

Frequency of daily urination

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Daytime Voids Between Baseline and 12 Month Follow-up	-1.61 number of voids Standard Deviation 1.85	-1.67 number of voids Standard Deviation 2.36

SECONDARY outcome

Timeframe: Baseline to 24 months

Frequency of daily urination

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Daytime Voids Between Baseline and 24 Month Follow-up	-0.33 number of voids Standard Deviation 3.92	-2.61 number of voids Standard Deviation 2.85

SECONDARY outcome

Timeframe: Baseline to 6 weeks

Frequency of night voiding

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Night Voids Between Baseline and 6 Week Follow-up	0.31 number of voids Standard Deviation 1.31	0.77 number of voids Standard Deviation 1.88

SECONDARY outcome

Timeframe: Baseline to 3 months

Frequency of night voiding

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Night Voids Between Baseline and 3 Month Follow-up	0.06 Number of voids Standard Deviation 1.29	1.36 Number of voids Standard Deviation 1.55

SECONDARY outcome

Timeframe: Baseline to 6 months

Frequency of night voiding

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Night Voids Between Baseline and 6 Month Follow-up	0.33 number of voids Standard Deviation 0.79	1.32 number of voids Standard Deviation 1.94

SECONDARY outcome

Timeframe: Baseline and 9 months

Frequency of night voiding

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Night Voids Between Baseline and 9 Month Follow-up	-1.13 Number of voids Standard Deviation 1.03	NA Number of voids Standard Deviation NA Data was not collected from this time period for the experimental group.

SECONDARY outcome

Timeframe: Baseline to 12 months

Frequency of night voiding

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Night Voids Between Baseline and 12 Month Follow-up	-0.94 number of voids Standard Deviation 1.16	-1.28 number of voids Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline and 24 months

Frequency of night voiding

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Number of Night Voids Between Baseline and 24 Months Follow-up	-0.72 number of voids Standard Deviation 1.25	-1.00 number of voids Standard Deviation 1.35

SECONDARY outcome

Timeframe: Baseline to 6 weeks

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Subjective Benefit Assessment at 6 Weeks	3.4 score on a 4-point rating scale Standard Deviation 0.9	2.4 score on a 4-point rating scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Subjective Benefit Assessment at 3 Months	3.2 score on a 4-point rating scale Standard Deviation 0.9	1.9 score on a 4-point rating scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Subjective Benefit Assessment at 6 Months	2.8 score on a 4-point rating scale Standard Deviation 0.9	1.6 score on a 4-point rating scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline to 6 weeks

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Impact Questionnaire From Baseline to 6 Weeks Follow-up	.00 scores on a scale Standard Deviation 14.02	27.27 scores on a scale Standard Deviation 41.51

SECONDARY outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Impact Questionnaire From Baseline to 3 Months Follow-up	4.29 summary score Standard Deviation 15.30	35.35 summary score Standard Deviation 41.19

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Incontinence Impact Questionnaire From Baseline to 6 Months Follow-up	3.81 summary score Standard Deviation 33.95	34.63 summary score Standard Deviation 36.76

SECONDARY outcome

Timeframe: Baseline to 6 weeks

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Urogenital Distress Inventory From Baseline to 6 Week Follow-up	6.11 summary score Standard Deviation 15.37	17.68 summary score Standard Deviation 30.20

SECONDARY outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Urogenital Distress Inventory From Baseline to 3 Months Follow-up	15.33 summary score Standard Deviation 14.44	32.32 summary score Standard Deviation 19.69

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Urogenital Distress Inventory From Baseline to 6 Months Follow-up	11.11 summary score Standard Deviation 23.57	28.48 summary score Standard Deviation 17.41

SECONDARY outcome

Timeframe: Baseline to 6 weeks

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Patient Perception of Bladder Condition From Baseline to 6 Weeks	.20 summary score Standard Deviation .79	1.45 summary score Standard Deviation 1.75

SECONDARY outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Patient Perception of Bladder Condition From Baseline to 3 Months	.50 summary score Standard Deviation 1.27	1.82 summary score Standard Deviation 1.94

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Patient Perception of Bladder Condition From Baseline to 6 Months	.50 summary score Standard Deviation 1.43	1.55 summary score Standard Deviation 1.75

SECONDARY outcome

Timeframe: Baseline to 6 weeks

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Indevus Urgency Severity Scale From Baseline to 6 Weeks	1.00 summary score Standard Deviation 0.88	1.09 summary score Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Indevus Urgency Severity Scale From Baseline to 3 Months	0.67 summary score Standard Deviation 1.0	1.36 summary score Standard Deviation 1.12

SECONDARY outcome

Timeframe: Baseline to 6 months

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.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Change in Indevus Urgency Severity Scale From Baseline to 6 Months	0.60 summary score Standard Deviation 0.97	1.09 summary score Standard Deviation .94

SECONDARY outcome

Timeframe: 3 months

weight of pad (in gm) worn for 24 hours to detect urine loss

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
24 Hour Pad Weight (gm) at 3 Months	413.30 gm Standard Deviation 558.82	141.18 gm Standard Deviation 301.93

SECONDARY outcome

Timeframe: 9 months

weight of pad (in gm) worn for 24 hours to detect urine loss

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
24 Hour Pad Weight (gm) at 9 Months	64.11 gm Standard Deviation 145.36	110.63 gm Standard Deviation 277.01

SECONDARY outcome

Timeframe: Baseline to 6 months

Frequency of urinary tract infections from baseline to 6 month-follow-up

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Frequency of Urinary Tract Infections From Baseline to 6 Months	4 number of occurences	6 number of occurences

SECONDARY outcome

Timeframe: Baseline to 6 months

Frequency of participants needing self-catheterization from baseline to 6 month follow-up.

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Frequency of Participants Needing Self-catheterization From Baseline to 6 Month Follow-up	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to 6 months

Frequency of particiapnts with urinary tract infections from baseline to 6 month-follow-up

Outcome measures

Measure	Placebo n=10 Participants 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 n=11 Participants 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
Frequency of Participants With Urinary Tract Infections From Baseline to 6 Months	4 Participants	6 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Botulinum Toxin Type A

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=10 participants at risk 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 n=11 participants at risk 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
Cardiac disorders Perioperative Cardiac Event (Takotsubo syndrome)	0.00% 0/10 • 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).	9.1% 1/11 • Number of events 1 • 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).

Other adverse events

Measure	Placebo n=10 participants at risk 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 n=11 participants at risk 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
Infections and infestations Hematuria	10.0% 1/10 • 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).	9.1% 1/11 • 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).
General disorders Pain/Discomfort	20.0% 2/10 • 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).	27.3% 3/11 • 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).
Gastrointestinal disorders Constipation	0.00% 0/10 • 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).	9.1% 1/11 • 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).

Additional Information

Dr. Corrine Jabs

Gynecology, Regina Qu'Appelle Health Region

Phone: (306) 586-3120

Email: corrinejabs@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place