NCT01767519

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

Completed Phase 3 Results posted Last updated 23 April 2019

What this trial tests

Phase 3 trial testing BOTOX® in Overactive Bladder in 356 participants. Completed in 18 March 2015.

Timeline

1 March 2013

Primary endpoint
30 September 2014

18 March 2015

Quick facts

Lead sponsor	Allergan
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	356
Start date	1 March 2013
Primary completion	30 September 2014
Estimated completion	18 March 2015
Sites	8 locations across Belgium, United Kingdom, Germany, Poland, Canada, United States, Czechia

Drugs / interventions tested

• BOTOX®
• solifenacin (SOLIFENACIN) — full drug profile →
• Botox placebo (normal saline) — full drug profile →
• solifenacin placebo

Conditions studied

• Overactive Bladder — all drugs for Overactive Bladder →
• Urinary Incontinence — all drugs for Urinary Incontinence →

Sponsor

Allergan — full company profile →

Who can join

18 and older, any sex, with Overactive Bladder or Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Study Baseline in Number of Episodes of Urinary Incontinence in Treatment Cycle 1 Primary · 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.

Study Baseline

Group	Value	95% CI
BOTOX®	4.86	± 3.206
Solifenacin	5.23	± 3.333
Placebo	4.38	± 2.485

Change from Study Baseline at Week 12

Group	Value	95% CI
BOTOX®	-3.10	± 2.799
Solifenacin	-2.66	± 3.059
Placebo	-0.98	± 2.417

Percentage of Patients With 100% Reduction in Incontinence Episodes in Treatment Cycle 1 Primary · 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.

Group	Value	95% CI
BOTOX®	33.8
Solifenacin	24.5
Placebo	11.7

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

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

Group	Value	95% CI
BOTOX®	71.3	62.9 – 78.7
Solifenacin	74.0	66.1 – 80.9
Placebo	44.8	31.7 – 58.5

Change From Study Baseline in the Number of Micturition Episodes in Treatment Cycle 1 Secondary · 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.

Study Baseline

Group	Value	95% CI
BOTOX®	10.74	± 2.520
Solifenacin	10.40	± 2.665
Placebo	10.18	± 2.491

Change from Study Baseline at Wk 12 (N=135,144,57)

Group	Value	95% CI
BOTOX®	-2.40	± 2.827
Solifenacin	-2.03	± 2.833
Placebo	-0.87	± 2.413

Change From Study Baseline in the Number of Nocturia Episodes in Treatment Cycle 1 Secondary · 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.

Study Baseline

Group	Value	95% CI
BOTOX®	2.03	± 1.159
Solifenacin	2.04	± 1.083
Placebo	1.98	± 0.937

Change from Study Baseline at Wk 12 (N=135,144,57)

Group	Value	95% CI
BOTOX®	-0.54	± 1.195
Solifenacin	-0.49	± 1.133
Placebo	-0.23	± 1.091

Change From Study Baseline in the Role Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 Secondary · 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.

Study Baseline

Group	Value	95% CI
BOTOX®	76.09	61.1 – 77.2
Solifenacin	72.11	51.5 – 68.0
Placebo	81.36	39.0 – 66.0

Change from Study Baseline at Wk 12 (N=135,145,57)

Group	Value	95% CI
BOTOX®	-30.0	52.0 – 69.0
Solifenacin	-23.79	49.5 – 66.1
Placebo	-17.25	29.1 – 55.9

Change From Study Baseline in the Social Limitations Domain on the King's Health Questionnaire in Treatment Cycle 1 Secondary · 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.

Study Baseline

Group	Value	95% CI
BOTOX®	59.66	61.1 – 77.2
Solifenacin	56.22	51.5 – 68.0
Placebo	62.57	39.0 – 66.0

Change from Study Baseline at Wk 12 (N=135,145,57)

Group	Value	95% CI
BOTOX®	-13.46	52.0 – 69.0
Solifenacin	-12.70	49.5 – 66.1
Placebo	-7.60	29.1 – 55.9

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

BOTOX®

Serious: 6/145 (4%)

Deaths: —

Solifenacin

Serious: 6/147 (4%)

Deaths: —

Placebo

Serious: 2/60 (3%)

Deaths: —

Serious adverse events (13 terms)

Reaction	System	BOTOX®	Solifenacin	Placebo
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—
Angina pectoris	Cardiac disorders	—	—	—
Bradycardia	Cardiac disorders	—	—	—
Myocardial ischaemia	Cardiac disorders	—	—	—
Cholelithiasis	Hepatobiliary disorders	—	—	—
Limb traumatic amputation	Injury, poisoning and procedural complications	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—
Migraine	Nervous system disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Anxiety	Psychiatric disorders	—	—	—
Polysubstance dependence	Psychiatric disorders	—	—	—
Haematuria	Renal and urinary disorders	—	—	—
Endometrial hyperplasia	Reproductive system and breast disorders	—	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	BOTOX®	Solifenacin	Placebo
Urinary tract infection	Infections and infestations	—	—	—
Bacteriuria	Infections and infestations	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—
Residual urine volume	Investigations	—	—	—
Urinary retention	Renal and urinary disorders	—	—	—
Dysuria	Renal and urinary disorders	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—

Most-reported serious reactions: Osteoarthritis, Angina pectoris, Bradycardia, Myocardial ischaemia, Cholelithiasis, Limb traumatic amputation, Breast cancer, Migraine.

Data from ClinicalTrials.gov NCT01767519 adverse events section.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis.
   He W, Huang G, Cui W, Tian Y, et al · · 2023 · cited 10× · PMID 37506033 · DOI 10.1590/s1677-5538.ibju.2023.0158
2. The Effects of Age, Gender, and Postvoid Residual Volume on Catheterization Rates After Treatment with OnabotulinumtoxinA for Overactive Bladder.
   Dmochowski R, Chapple C, Gruenenfelder J, Yu J, et al · · 2023 · cited 4× · PMID 38020522 · DOI 10.1016/j.euros.2023.09.013