Overactive Bladder
Conditions
Brief summary
The purpose of this study is to explore the effectiveness and safety of several doses of botulinum toxin type A in treating overactive bladder in patients with spinal cord injury.
Interventions
Placebo injection on Day 1 and botulinum toxin Type A injection 200 U \> Week 12; injection into the detrusor
BIOLOGICALbotulinum toxin Type A (50U); botulinum toxin Type A (200U)
botulinum toxin Type A 50 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor
BIOLOGICALbotulinum toxin Type A (100U); botulinum toxin Type A (200U)
botulinum toxin Type A 100 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor
BIOLOGICALbotulinum toxin Type A (200U)
botulinum toxin Type A 200 U on Day 1 followed by botulinum toxin Type A 200 U \> 12 weeks; injections into the detrusor
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury * Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion criteria
* History or evidence of pelvic or urologic abnormality * Previous or current diagnosis of bladder or prostate cancer * Urinary tract infection at time of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Baseline, Week 6 | Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline, Week 6 | Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds. |
| Change From Baseline in Maximum Detrusor Pressure (MDP) | Baseline, Week 6 | Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement. |
Countries
Egypt, Greece, India, Lebanon, Serbia, Turkey (Türkiye)
Participant flow
Pre-assignment details
Of the 74 patients enrolled into the study, 73 patients received study medication and are included in the analyses. One patient was enrolled but did not receive study medication.
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A (200U) botulinum toxin Type A (200U) | 17 |
| Botulinum Toxin Type A (100U) botulinum toxin Type A (100U) | 21 |
| Botulinum Toxin Type A (50U) botulinum toxin Type A (50U) | 19 |
| Placebo Normal saline (placebo) | 17 |
| Total | 74 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A (200U) | Botulinum Toxin Type A (100U) | Botulinum Toxin Type A (50U) | Placebo | Total |
|---|---|---|---|---|---|
| Age, Customized < 40 years | 13 participants | 13 participants | 16 participants | 11 participants | 53 participants |
| Age, Customized >= 75 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Age, Customized Between 40 and 64 years | 4 participants | 8 participants | 3 participants | 6 participants | 21 participants |
| Age, Customized Between 65 and 74 years | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 2 Participants | 1 Participants | 10 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 17 Participants | 16 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 11 / 17 | 17 / 21 | 11 / 19 | 13 / 16 |
| serious Total, serious adverse events | 2 / 17 | 2 / 21 | 2 / 19 | 6 / 16 |
Outcome results
Primary
Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).
Time frame: Baseline, Week 6
Population: Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A (200U) | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Baseline | 28.8 Number of Weekly Episodes | Standard Deviation 20.26 |
| Botulinum Toxin Type A (200U) | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Week 6 | -15.8 Number of Weekly Episodes | Standard Deviation 18.01 |
| Botulinum Toxin Type A (100U) | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Week 6 | -14.1 Number of Weekly Episodes | Standard Deviation 23.9 |
| Botulinum Toxin Type A (100U) | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Baseline | 37.8 Number of Weekly Episodes | Standard Deviation 27.63 |
| Botulinum Toxin Type A (50U) | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Baseline | 26.3 Number of Weekly Episodes | Standard Deviation 19.29 |
| Botulinum Toxin Type A (50U) | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Week 6 | -7.7 Number of Weekly Episodes | Standard Deviation 11.52 |
| Placebo | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Baseline | 24.6 Number of Weekly Episodes | Standard Deviation 9.08 |
| Placebo | Change From Baseline in Number of Weekly Episodes of Urinary Incontinence | Week 6 | -8.6 Number of Weekly Episodes | Standard Deviation 8.12 |
Secondary
Change From Baseline in Maximum Cystometric Capacity (MCC)
Change from baseline in MCC at week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.
Time frame: Baseline, Week 6
Population: Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A (200U) | Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline | 214.2 Milliliters (mL) of urine | Standard Deviation 96.56 |
| Botulinum Toxin Type A (200U) | Change From Baseline in Maximum Cystometric Capacity (MCC) | Week 6 | 183.7 Milliliters (mL) of urine | Standard Deviation 197.63 |
| Botulinum Toxin Type A (100U) | Change From Baseline in Maximum Cystometric Capacity (MCC) | Week 6 | 220.1 Milliliters (mL) of urine | Standard Deviation 183.05 |
| Botulinum Toxin Type A (100U) | Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline | 161.6 Milliliters (mL) of urine | Standard Deviation 66.13 |
| Botulinum Toxin Type A (50U) | Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline | 213.9 Milliliters (mL) of urine | Standard Deviation 135.41 |
| Botulinum Toxin Type A (50U) | Change From Baseline in Maximum Cystometric Capacity (MCC) | Week 6 | 136.8 Milliliters (mL) of urine | Standard Deviation 189.37 |
| Placebo | Change From Baseline in Maximum Cystometric Capacity (MCC) | Baseline | 189.8 Milliliters (mL) of urine | Standard Deviation 103.56 |
| Placebo | Change From Baseline in Maximum Cystometric Capacity (MCC) | Week 6 | 117.4 Milliliters (mL) of urine | Standard Deviation 173.51 |
Secondary
Change From Baseline in Maximum Detrusor Pressure (MDP)
Change from baseline in MDP during first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.
Time frame: Baseline, Week 6
Population: Modified Intent-To-Treat: defined as all patients who were randomized (started study) and received treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botulinum Toxin Type A (200U) | Change From Baseline in Maximum Detrusor Pressure (MDP) | Baseline | 62.9 Centimeters of water (cm H2O) | Standard Deviation 72.05 |
| Botulinum Toxin Type A (200U) | Change From Baseline in Maximum Detrusor Pressure (MDP) | Week 6 | -33.0 Centimeters of water (cm H2O) | Standard Deviation 58.06 |
| Botulinum Toxin Type A (100U) | Change From Baseline in Maximum Detrusor Pressure (MDP) | Week 6 | -29.4 Centimeters of water (cm H2O) | Standard Deviation 39.67 |
| Botulinum Toxin Type A (100U) | Change From Baseline in Maximum Detrusor Pressure (MDP) | Baseline | 54.2 Centimeters of water (cm H2O) | Standard Deviation 41.47 |
| Botulinum Toxin Type A (50U) | Change From Baseline in Maximum Detrusor Pressure (MDP) | Baseline | 52.7 Centimeters of water (cm H2O) | Standard Deviation 39.51 |
| Botulinum Toxin Type A (50U) | Change From Baseline in Maximum Detrusor Pressure (MDP) | Week 6 | -20.1 Centimeters of water (cm H2O) | Standard Deviation 22.07 |
| Placebo | Change From Baseline in Maximum Detrusor Pressure (MDP) | Baseline | 45.9 Centimeters of water (cm H2O) | Standard Deviation 36.82 |
| Placebo | Change From Baseline in Maximum Detrusor Pressure (MDP) | Week 6 | -2.1 Centimeters of water (cm H2O) | Standard Deviation 27.65 |