Overactive Bladder
Conditions
Keywords
Solifenacin succinate, Oxybutynin immediate release, Xerostomia, Overactive bladder
Brief summary
The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
Detailed description
This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
Interventions
DRUGsolifenacin
Oral
DRUGoxybutynin immediate release
Oral
Sponsors
Astellas Pharma Canada, Inc.
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults 18 years and older. * Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: \> 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)
Exclusion criteria
* Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones * Clinically significant outflow obstruction * Uncontrolled narrow angle glaucoma, urinary, or gastric retention * Severe renal or hepatic impairment * Chronic severe constipation or history of diagnosed GI obstructive disease * Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor * Diagnosis or history of neurogenic bladder * History of bladder or pelvic cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event | 8 weeks | The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit |
| The Severity of Dry Mouth Reported as an Adverse Event | 8 weeks | The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE). Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Baseline and 8 Weeks | Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline. |
| Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Baseline and 8 weeks | Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Solifenacin Solifenacin succinate: 5 mg tablets, taken orally, once daily | 68 |
| Oxybutynin IR Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day | 64 |
| Total | 132 |
Baseline characteristics
| Characteristic | Solifenacin | Oxybutynin IR | Total |
|---|---|---|---|
| Age, Customized <=65 years | 41 participants | 34 participants | 75 participants |
| Age, Customized >65 years | 27 participants | 30 participants | 57 participants |
| Race/Ethnicity, Customized Aboriginal | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Black | 2 participants | 5 participants | 7 participants |
| Race/Ethnicity, Customized Caucasian | 62 participants | 57 participants | 119 participants |
| Race/Ethnicity, Customized Hispanic | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 2 participants |
| Sex: Female, Male Female | 51 Participants | 52 Participants | 103 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 36 / 68 | 56 / 64 |
| serious Total, serious adverse events | 3 / 68 | 0 / 64 |
Outcome results
Primary
The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
Time frame: 8 weeks
Population: Data represents ITT Population: all randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Solifenacin | The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event | 24 participants |
| Oxybutynin IR | The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event | 53 participants |
p-value: <0.0001Chi-squared
Primary
The Severity of Dry Mouth Reported as an Adverse Event
The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE). Dry mouth severity was categorized as mild (relieved with fluid/hard candy), moderate (dry mouth and throat with no difficulty swallowing solid food/water) & severe (very dry mouth & throat, difficulty swallowing solid food without water)
Time frame: 8 weeks
Population: Data represents ITT Population: all randomized subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Solifenacin | The Severity of Dry Mouth Reported as an Adverse Event | Mild | 18 participants |
| Solifenacin | The Severity of Dry Mouth Reported as an Adverse Event | Moderate | 3 participants |
| Solifenacin | The Severity of Dry Mouth Reported as an Adverse Event | Severe | 3 participants |
| Oxybutynin IR | The Severity of Dry Mouth Reported as an Adverse Event | Mild | 16 participants |
| Oxybutynin IR | The Severity of Dry Mouth Reported as an Adverse Event | Moderate | 22 participants |
| Oxybutynin IR | The Severity of Dry Mouth Reported as an Adverse Event | Severe | 15 participants |
p-value: 0.001Chi-squared
Secondary
Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline.
Time frame: Baseline and 8 Weeks
Population: Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Change in micturition frequency at 8 wks(N=52; 40) | -2.3 Micturitions per day | Standard Deviation 3.3 |
| Solifenacin | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Micturition frequency at Baseline (N=68; 64) | 12.4 Micturitions per day | Standard Deviation 3.2 |
| Solifenacin | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Micturition frequency at 8 weeks (N=52; 40) | 9.9 Micturitions per day | Standard Deviation 3.7 |
| Oxybutynin IR | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Change in micturition frequency at 8 wks(N=52; 40) | -3.1 Micturitions per day | Standard Deviation 2.7 |
| Oxybutynin IR | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Micturition frequency at Baseline (N=68; 64) | 12.5 Micturitions per day | Standard Deviation 3.1 |
| Oxybutynin IR | Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary | Micturition frequency at 8 weeks (N=52; 40) | 9.0 Micturitions per day | Standard Deviation 2.9 |
Secondary
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline.
Time frame: Baseline and 8 weeks
Population: Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Solifenacin | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Change in urgency episodes at 8 weeks (N=52; 40) | -2.65 urgency episodes per day | Standard Deviation 4.54 |
| Solifenacin | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Urgency episodes at Baseline (N= 68; 64) | 6.3 urgency episodes per day | Standard Deviation 3.98 |
| Solifenacin | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Urgency episodes at 8 weeks (N=52; 40) | 3.8 urgency episodes per day | Standard Deviation 5.04 |
| Oxybutynin IR | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Change in urgency episodes at 8 weeks (N=52; 40) | -3.70 urgency episodes per day | Standard Deviation 3.26 |
| Oxybutynin IR | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Urgency episodes at Baseline (N= 68; 64) | 6.6 urgency episodes per day | Standard Deviation 4.43 |
| Oxybutynin IR | Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary | Urgency episodes at 8 weeks (N=52; 40) | 2.1 urgency episodes per day | Standard Deviation 2.88 |