A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01767519
• Collaborator: (none)
• Enrollment: 356
• Locations: 8
• Arms: 3
• Actual Duration (Months): 24.5
• Patients Per Site: 44.5
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

A study to evaluate the efficacy and safety of BOTOX® or Solifenacin in patients with overactive bladder (OAB) and urinary incontinence.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder; Urinary Incontinence	Biological: BOTOX®; Drug: solifenacin; Drug: Botox placebo (normal saline); Drug: solifenacin placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 356 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Sep 30, 2014
• Actual Study Completion Date: Mar 18, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BOTOX® Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Biological: BOTOX®; BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.; Other Names: onabotulinumtoxinA botulinum toxin Type A ; Drug: solifenacin placebo; Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.
Active Comparator: solifenacin Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Biological: BOTOX®; BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.; Other Names: onabotulinumtoxinA botulinum toxin Type A ; Drug: solifenacin; Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks.; Other Names: Vesicare ; Drug: Botox placebo (normal saline); Botox placebo (normal saline) intradetrusor injection at Day 1.
Placebo Comparator: placebo Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Biological: BOTOX®; BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.; Other Names: onabotulinumtoxinA botulinum toxin Type A ; Drug: Botox placebo (normal saline); Botox placebo (normal saline) intradetrusor injection at Day 1.; Drug: solifenacin placebo; Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.

Outcome Measures

Primary Outcome Measures

1. Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 [Study Baseline, Week 12]

   Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

2. Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 [Study Baseline, Week 12]

   Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.

Secondary Outcome Measures

1. Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1 [Week 12]

   A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'

2. Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 [Study Baseline, Week 12]

   The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

3. Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 [Study Baseline, Week 12]

   Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

4. Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 [Study Baseline, Week 12]

   The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

5. Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 [Study Baseline, Week 12]

   The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Symptoms of Overactive Bladder (OAB) (frequency/urgency) with urinary incontinence for at least 6 months

• Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria:

• Overactive Bladder caused by neurological condition

• Patient has predominance of stress incontinence

• Use of anticholinergics or other medications to treat OAB symptoms in the 7 days prior to screening

• Previous use of solifenacin

• History or evidence of pelvic or urological abnormality

• Previous use of any botulinum toxin of any serotype for any urological condition

• Previous use of any botulinum toxin of any serotype for any non-urological condition within 12 weeks of randomization

• Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Newport Beach	California	United States
2		Leuven		Belgium
3		Vancouver	British Columbia	Canada
4		Toronto	Ontario	Canada
5		Prague 6		Czechia
6		Berlin		Germany
7		Warsaw		Poland
8		London		United Kingdom

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Herschorn S, Kohan A, Aliotta P, McCammon K, Sriram R, Abrams S, Lam W, Everaert K. The Efficacy and Safety of OnabotulinumtoxinA or Solifenacin Compared with Placebo in Solifenacin Naïve Patients with Refractory Overactive Bladder: Results from a Multicenter, Randomized, Double-Blind Phase 3b Trial. J Urol. 2017 Jul;198(1):167-175. doi: 10.1016/j.juro.2017.01.069. Epub 2017 Feb 1.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01767519
• Other Study ID Numbers: 191622-125
• First Posted: Jan 14, 2013
• Last Update Posted: Apr 23, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Solifenacin Succinate; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA

Study Results

Participant Flow

Recruitment Details	Participant Flow is for Treatment cycle 1, which is the double-blind portion of the study and includes the primary timepoint.

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Period Title: Overall Study
STARTED	145	151	60
COMPLETED	131	138	55
NOT COMPLETED	14	13	5

Baseline Characteristics

Arm/Group Title	BOTOX®	Solifenacin	Placebo	Total
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Total of all reporting groups
Overall Participants	145	151	60	356
Age, Customized (Number) [Number]
<65 years	77 53.1%	79 52.3%	34 56.7%	190 53.4%
≥65 years	68 46.9%	72 47.7%	26 43.3%	166 46.6%
Sex: Female, Male (Count of Participants)
Female	123 84.8%	134 88.7%	51 85%	308 86.5%
Male	22 15.2%	17 11.3%	9 15%	48 13.5%

Outcome Measures

1. Primary Outcome

Title	Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1
Description	Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame	Study Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: includes all patients according to the group to which they are randomized

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Measure Participants	145	151	60
Study Baseline	4.86 (3.206)	5.23 (3.333)	4.38 (2.485)
Change from Study Baseline at Week 12	-3.10 (2.799)	-2.66 (3.059)	-0.98 (2.417)

2. Primary Outcome

Title	Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1
Description	Urinary incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary in the 3 consecutive days prior to the study visit in Treatment Cycle 1. The number of incontinence episodes are averaged daily during this period and compared to baseline to determine 100% reduction in episodes.
Time Frame	Study Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: includes all patients according to the group to which they are randomized

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Measure Participants	145	151	60
Number [Percentage of Patients]	33.8	24.5	11.7

3. Secondary Outcome

Title	Percentage of Patients With a Positive Response on the Single-Item Treatment Benefit Scale During Treatment Cycle 1
Description	A positive treatment response on the Treatment Benefit Scale is a score of either 1 or 2, representing 'greatly improved' or 'improved.'
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: includes all patients according to the group to which they are randomized

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Measure Participants	145	151	60
Number (95% Confidence Interval) [Percentage of Patients]	71.3	74.0	44.8

4. Secondary Outcome

Title	Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1
Description	The number of micturition episodes (the number of times a patient urinates into the toilet) in Treatment Cycle 1 was recorded by the patient in a bladder diary during 3 consecutive days in the week prior to the visit. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame	Study Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: includes all patients according to the group to which they are randomized

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Measure Participants	145	151	60
Study Baseline	10.74 (2.520)	10.40 (2.665)	10.18 (2.491)
Change from Study Baseline at Wk 12 (N=135,144,57)	-2.40 (2.827)	-2.03 (2.833)	-0.87 (2.413)

5. Secondary Outcome

Title	Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1
Description	Nocturia episodes are measured over a 3 day diary prior to each visit in Treatment Cycle 1. A nocturia episode is a void (urinating into the toilet) that interrupts one's sleep. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame	Study Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: includes all patients according to the group to which they are randomized

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Measure Participants	145	151	60
Study Baseline	2.03 (1.159)	2.04 (1.083)	1.98 (0.937)
Change from Study Baseline at Wk 12 (N=135,144,57)	-0.54 (1.195)	-0.49 (1.133)	-0.23 (1.091)

6. Secondary Outcome

Title	Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Description	The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the role limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame	Study Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: includes all patients according to the group to which they are randomized

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Measure Participants	145	150	59
Study Baseline	76.09 (24.281)	72.11 (26.581)	81.36 (20.781)
Change from Study Baseline at Wk 12 (N=135,145,57)	-30.0 (33.259)	-23.79 (31.899)	-17.25 (29.033)

7. Secondary Outcome

Title	Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1
Description	The King's Health Questionnaire is a disease-specific questionnaire that measures the quality of life of patients with urinary incontinence. The questionnaire consists of 7 domains, including the social limitations domain. Domain scores range from 0 to 100, with a lower score indicating a preferable health status. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame	Study Baseline, Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat: includes all patients according to the group to which they are randomized

Arm/Group Title	BOTOX®	Solifenacin	Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.	Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.	Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
Measure Participants	145	150	59
Study Baseline	59.66 (21.442)	56.22 (22.708)	62.57 (22.551)
Change from Study Baseline at Wk 12 (N=135,145,57)	-13.46 (21.906)	-12.70 (21.361)	-7.60 (21.667)

Adverse Events

Adverse Event Reporting Description	The safety population includes all patients who received at least 1 dose of study medication. The safety population is used to assess adverse events and serious adverse events. Adverse events and serious adverse events are displayed for the placebo-controlled treatment Cycle 1.
Arm/Group Title	BOTOX®		Solifenacin		Placebo
Arm/Group Description	Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.		Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.		Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
All Cause Mortality
	BOTOX®		Solifenacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	BOTOX®		Solifenacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/145 (4.1%)		6/147 (4.1%)		2/60 (3.3%)
Cardiac disorders
Angina pectoris	1/145 (0.7%)		0/147 (0%)		0/60 (0%)
Bradycardia	1/145 (0.7%)		0/147 (0%)		0/60 (0%)
Myocardial ischaemia	1/145 (0.7%)		0/147 (0%)		0/60 (0%)
Hepatobiliary disorders
Cholelithiasis	0/145 (0%)		1/147 (0.7%)		0/60 (0%)
Injury, poisoning and procedural complications
Limb traumatic amputation	1/145 (0.7%)		0/147 (0%)		0/60 (0%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/145 (0%)		2/147 (1.4%)		0/60 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer	1/145 (0.7%)		1/147 (0.7%)		0/60 (0%)
Nervous system disorders
Migraine	1/145 (0.7%)		0/147 (0%)		0/60 (0%)
Dizziness	0/145 (0%)		0/147 (0%)		1/60 (1.7%)
Psychiatric disorders
Anxiety	1/145 (0.7%)		0/147 (0%)		0/60 (0%)
Polysubstance dependence	0/145 (0%)		1/147 (0.7%)		0/60 (0%)
Renal and urinary disorders
Haematuria	0/145 (0%)		0/147 (0%)		1/60 (1.7%)
Reproductive system and breast disorders
Endometrial hyperplasia	0/123 (0%)		1/131 (0.8%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	BOTOX®		Solifenacin		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	57/145 (39.3%)		40/147 (27.2%)		13/60 (21.7%)
Gastrointestinal disorders
Dry mouth	4/145 (2.8%)		12/147 (8.2%)		0/60 (0%)
Infections and infestations
Urinary tract infection	37/145 (25.5%)		15/147 (10.2%)		6/60 (10%)
Bacteriuria	11/145 (7.6%)		14/147 (9.5%)		3/60 (5%)
Nasopharyngitis	2/145 (1.4%)		2/147 (1.4%)		3/60 (5%)
Investigations
Residual urine volume	10/145 (6.9%)		0/147 (0%)		1/60 (1.7%)
Renal and urinary disorders
Urinary retention	10/145 (6.9%)		1/147 (0.7%)		0/60 (0%)
Dysuria	6/145 (4.1%)		8/147 (5.4%)		2/60 (3.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.