Trial Outcomes & Findings for Anticholinergic vs. Botox Comparison Study (NCT NCT01166438)
NCT ID: NCT01166438
Last Updated: 2018-05-02
Results Overview
Change from baseline in mean number of UUI episodes over 6 month double-blind period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
249 participants
Primary outcome timeframe
Baseline through 6 months
Results posted on
2018-05-02
Participant Flow
Participant milestones
| Measure |
Botox A
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
|---|---|---|
|
Double-blind Phase: 1st 6 Months
STARTED
|
122
|
127
|
|
Double-blind Phase: 1st 6 Months
Treated
|
121
|
126
|
|
Double-blind Phase: 1st 6 Months
COMPLETED
|
113
|
118
|
|
Double-blind Phase: 1st 6 Months
NOT COMPLETED
|
9
|
9
|
|
Off Treatment Follow-up Phase
STARTED
|
85
|
89
|
|
Off Treatment Follow-up Phase
COMPLETED
|
51
|
33
|
|
Off Treatment Follow-up Phase
NOT COMPLETED
|
34
|
56
|
Reasons for withdrawal
| Measure |
Botox A
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
|---|---|---|
|
Double-blind Phase: 1st 6 Months
Withdrawal by Subject
|
8
|
4
|
|
Double-blind Phase: 1st 6 Months
Lost to Follow-up
|
0
|
4
|
|
Double-blind Phase: 1st 6 Months
Not treated
|
1
|
1
|
|
Off Treatment Follow-up Phase
Withdrawal by Subject
|
1
|
2
|
|
Off Treatment Follow-up Phase
Lost to Follow-up
|
4
|
2
|
|
Off Treatment Follow-up Phase
Lack of Efficacy
|
29
|
52
|
Baseline Characteristics
Anticholinergic vs. Botox Comparison Study
Baseline characteristics by cohort
| Measure |
Botox A
n=121 Participants
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=126 Participants
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.3 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
56.7 Years
STANDARD_DEVIATION 11.6 • n=7 Participants
|
57.9 Years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
99 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
96 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital Status
Married or living as married
|
58 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Marital Status
Divorced, separated, or widowed
|
44 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Marital Status
Single, never married
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Marital Status
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital Status
Not reported
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Educational level at least some college
|
86 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Type of health insurance
Private only
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Type of health insurance
Medicare or Medicaid only
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Type of health insurance
Other only
|
28 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Type of health insurance
Combination of several types
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Type of health insurance
Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Smoking status
Never smoked
|
66 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Smoking status
Previous smoker
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Smoking status
Current smoker
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Smoking status
Not reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Menopausal status
Premenopausal
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Menopausal status
Postmenopausal
|
102 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
194 Participants
n=5 Participants
|
|
Menopausal status
Not sure
|
4 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
No prior anticholinergic therapy
|
48 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline through 6 monthsChange from baseline in mean number of UUI episodes over 6 month double-blind period.
Outcome measures
| Measure |
Botox A
n=119 Participants
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=122 Participants
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
|---|---|---|
|
Change in Urge Urinary Incontinence (UUI) Episodes
1 Month
|
-3.13 Mean change in UUI episodes from baselin
Standard Error 0.2851
|
-3.15 Mean change in UUI episodes from baselin
Standard Error 0.2761
|
|
Change in Urge Urinary Incontinence (UUI) Episodes
2 Months
|
-3.32 Mean change in UUI episodes from baselin
Standard Error 0.2854
|
-3.25 Mean change in UUI episodes from baselin
Standard Error 0.2762
|
|
Change in Urge Urinary Incontinence (UUI) Episodes
3 Months
|
-3.22 Mean change in UUI episodes from baselin
Standard Error 0.2854
|
-3.55 Mean change in UUI episodes from baselin
Standard Error 0.278
|
|
Change in Urge Urinary Incontinence (UUI) Episodes
4 Months
|
-3.36 Mean change in UUI episodes from baselin
Standard Error 0.2857
|
-3.40 Mean change in UUI episodes from baselin
Standard Error 0.2766
|
|
Change in Urge Urinary Incontinence (UUI) Episodes
5 Months
|
-3.42 Mean change in UUI episodes from baselin
Standard Error 0.2881
|
-3.49 Mean change in UUI episodes from baselin
Standard Error 0.2777
|
|
Change in Urge Urinary Incontinence (UUI) Episodes
6 Months
|
-3.27 Mean change in UUI episodes from baselin
Standard Error 0.2864
|
-3.33 Mean change in UUI episodes from baselin
Standard Error 0.2775
|
SECONDARY outcome
Timeframe: Baseline through 6 monthsValues for the Overactive Bladder Questionnaire Short Form (OABq-SF) are changes from baseline in the adjusted mean scores for months 1 to 6. Scores on the OABq-SF range from 0 to 100, with higher scores on the symptom-severity scale indicating greater severity of symptoms and higher scores on the quality-of-life scale indicating better quality of life. Data were available for 123 participants in the Standardized Anticholinergic Regimen group and 119 in the Botox A A group.
Outcome measures
| Measure |
Botox A
n=119 Participants
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=123 Participants
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
|---|---|---|
|
Change From Baseline in Score on OABq-SF
OABq-SF Symptom Severity Score
|
-44.08 Change from baseline in score on OABq-SF
Standard Error 2.54
|
-44.55 Change from baseline in score on OABq-SF
Standard Error 2.44
|
|
Change From Baseline in Score on OABq-SF
OABq-SF Quality of Life Score
|
37.13 Change from baseline in score on OABq-SF
Standard Error 2.578
|
37.05 Change from baseline in score on OABq-SF
Standard Error 2.479
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Efficacy outcomes were assessed in the modified intention-to-treat population, which included all participants who underwent randomization and received a study medication and who had a baseline measure and at least one follow-up measure for the outcome. Proportions were based on data from participants who returned at least four follow-up diaries.
Efficacy outcomes assessed reduction and resolution of incontinence, including urgency urinary incontinence (UUI).
Outcome measures
| Measure |
Botox A
n=112 Participants
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=119 Participants
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
|---|---|---|
|
Efficacy
Complete resolution of UUI
|
30 Participants
|
16 Participants
|
|
Efficacy
Complete resolution of all incontinence
|
26 Participants
|
13 Participants
|
|
Efficacy
>75% reduction in UUI episodes
|
61 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline through 6 monthsPopulation: Data were available for 111 participants in the Standardized Anticholinergic Regimen group and 102 in the Botox A group.
Values for Pelvic Floor Distress Inventory Short Form (PFDI-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFDI-SF range from 0 to 300, with higher scores indicating more symptoms and more bothersome symptoms. Values for the Pelvic Floor Impact Questionnaire Short Form (PFIQ-SF) are changes from baseline in the adjusted mean scores for months 3 to 6. Scores on the PFIQ-SF range from 0 to 300, with higher scores indicating a more negative effect on activities, relationships, and feelings.
Outcome measures
| Measure |
Botox A
n=102 Participants
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=111 Participants
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
|---|---|---|
|
Change in PFDI-SF and PFIQ-SF Total Scores
Change from baseline in PFDI-SF total score
|
-48.20 Changes in adjusted mean scores
Standard Error 5.56
|
-43.69 Changes in adjusted mean scores
Standard Error 5.34
|
|
Change in PFDI-SF and PFIQ-SF Total Scores
Change from baseline in PFIQ-SF total score
|
-33.85 Changes in adjusted mean scores
Standard Error 6.313
|
-32.82 Changes in adjusted mean scores
Standard Error 6.065
|
SECONDARY outcome
Timeframe: 3 and 6 monthsThe Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse). Included here are participants who had adequate improvement, defined as a rating of 1 or 2 (much better).
Outcome measures
| Measure |
Botox A
n=111 Participants
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=116 Participants
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
Solifenacin 5mg: Oral Solifenacin 5mg once a day for up to 6 months
Solifenacin 10mg: Oral Solifenacin 10mg once a day for up to 4 mon
|
|---|---|---|
|
Patient Global Impression of Improvement
Month 3
|
61 Participants
|
59 Participants
|
|
Patient Global Impression of Improvement
Month 6
|
60 Participants
|
67 Participants
|
Adverse Events
Botox A
Serious events: 5 serious events
Other events: 96 other events
Deaths: 0 deaths
Standardized Anticholinergic Regimen
Serious events: 7 serious events
Other events: 97 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Botox A
n=121 participants at risk
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=126 participants at risk
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. Dose escalation or drug change will be based exclusively on the result of the Patient Global Symptom Control Rating. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
|
|---|---|---|
|
Cardiac disorders
Cardiac septal hypertrophy
|
0.00%
0/121
|
0.79%
1/126
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/121
|
0.79%
1/126
|
|
Infections and infestations
Appendicitis
|
0.00%
0/121
|
0.79%
1/126
|
|
Infections and infestations
Upper respiratory tract infection
|
0.83%
1/121
|
0.00%
0/126
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/121
|
0.79%
1/126
|
|
General disorders
Chest Pain
|
0.00%
0/121
|
0.79%
1/126
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/121
|
0.79%
1/126
|
|
Injury, poisoning and procedural complications
Head injury
|
0.83%
1/121
|
0.00%
0/126
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/121
|
0.00%
0/126
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/121
|
0.79%
1/126
|
|
Nervous system disorders
Convulsion
|
0.83%
1/121
|
0.00%
0/126
|
|
Renal and urinary disorders
Haematuria
|
0.83%
1/121
|
0.00%
0/126
|
Other adverse events
| Measure |
Botox A
n=121 participants at risk
A single intradetrusor injection of 100U botulinum toxin A (Botox A®) plus daily oral placebo tablets
Botulinum toxin A (Botox A®): A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
|
Standardized Anticholinergic Regimen
n=126 participants at risk
A standardized 3-step anticholinergic regimen of daily oral solifenacin 5mg, solifenacin 10mg, and/or trospium XR 60mg, as well as a single intradetrusor injection of saline (placebo). All subjects will begin on solifenacin 5 mg for 2 mo. Dose escalation or drug change will be based exclusively on the result of the Patient Global Symptom Control Rating. If a subject's symptoms are not adequately controlled at 2 mo, she will be escalated to solifenacin 10mg, and similarly at 4 mo to trospium XR 60mg. If a subject's symptoms are adequately controlled on solifenacin 5 mg, she may continue that study medication for the entirety of the study (6 mo). Additionally, if a subject is dose-escalated to solifenacin 10mg at study mo 2 or 4, and her symptoms are adequately controlled, she may continue the solifenacin 10mg dose for the remainder of the study.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
25.6%
31/121
|
29.4%
37/126
|
|
Gastrointestinal disorders
Diarrhea
|
17.4%
21/121
|
11.9%
15/126
|
|
Gastrointestinal disorders
Dry mouth
|
36.4%
44/121
|
50.8%
64/126
|
|
Gastrointestinal disorders
Nausea
|
5.0%
6/121
|
4.0%
5/126
|
|
Gastrointestinal disorders
Any Gastrointestinal Disorders
|
52.1%
63/121
|
58.7%
74/126
|
|
General disorders
Chills
|
9.9%
12/121
|
9.5%
12/126
|
|
General disorders
Influenza-like illness
|
7.4%
9/121
|
5.6%
7/126
|
|
General disorders
Injection site pain
|
28.1%
34/121
|
28.6%
36/126
|
|
General disorders
Pyrexia
|
6.6%
8/121
|
4.8%
6/126
|
|
General disorders
Any General Disorders and Administration Site Conditions
|
40.5%
49/121
|
32.5%
41/126
|
|
Renal and urinary disorders
Haematuria
|
23.1%
28/121
|
18.3%
23/126
|
|
Renal and urinary disorders
Urine abnormality
|
14.0%
17/121
|
11.1%
14/126
|
|
Renal and urinary disorders
Urine odour abnormal
|
13.2%
16/121
|
7.9%
10/126
|
|
Renal and urinary disorders
Any Renal and Urinary Disorders
|
40.5%
49/121
|
30.2%
38/126
|
|
Eye disorders
Dry eye
|
26.4%
32/121
|
24.6%
31/126
|
|
Eye disorders
Any Eye Disorders
|
28.1%
34/121
|
24.6%
31/126
|
|
Infections and infestations
Urinary tract infection
|
30.6%
37/121
|
15.1%
19/126
|
|
Infections and infestations
Any Infections and Infestations
|
30.6%
37/121
|
15.9%
20/126
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
6.6%
8/121
|
2.4%
3/126
|
|
Musculoskeletal and connective tissue disorders
Any Musculoskeletal and Connective Tissue Disorders
|
9.1%
11/121
|
4.0%
5/126
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.6%
8/121
|
4.8%
6/126
|
|
Skin and subcutaneous tissue disorders
Any Skin and Subcutaneous Tissue Disorders
|
6.6%
8/121
|
4.8%
6/126
|
|
Immune system disorders
Hypersensitivity
|
5.8%
7/121
|
0.79%
1/126
|
|
Immune system disorders
Any Immune System Disorders
|
5.8%
7/121
|
0.79%
1/126
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place