overactive bladder
Conditions
Interventions
The study consists of 9 visits: visit 1 (screening), visit 2 (placebo run-in),
visit 3 (randomization), visit 4, 5, 6, 7 & 8 (double-blind treatment), visit 9
(follow-up ).
Screening Phase (Visit 1
Sponsors
Astellas Pharma
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Inclusion Criteria at Visit 1/Screening: 1. Subject is male or female and at least 18 years of age; 2. Subject has a Body Mass Index (BMI) of between 18 and 35 kg/m2 and a total body weight between 50 and 95 kg; 3. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent and privacy language as per national regulations has been obtained from the subject prior to any study-related procedures (including discontinuation of prohibited medication, if applicable); 4. Subject is willing and able to complete the micturition diary and questionnaires correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; 5. Subject has symptoms of OAB (urinary frequency, urgency and/or urgency incontinence) for at least 3 months.;* Inclusion Criteria at Visit 2/Placebo Run-In 6. Subject must still fulfill all inclusion criteria and none of the exclusion criteria for Visit 1; 7. Subject is willing and able to complete the micturition diary correctly and is willing and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings.;* Inclusion Criteria at Visit 3/Baseline 8. Subject continues to meet all inclusion criteria and none of the exclusion criteria for Visit 1; 9. Subject has experienced frequency of micturition on average * 8 times per 24-hour period during the 3-day micturition diary period (incontinence episode should not be counted as a micturition); 10. Subject must experience at least 1 episode of urgency (grade 3 or 4) per 24-hour period (with or without urgency incontinence) during the 3-day micturition diary period.
Exclusion criteria
Exclusion criteria: * Exclusion Criteria at Visit 1/Screening 1. Subject is breastfeeding, pregnant or intends to become pregnant during the study. The pregnancy test (*-HCG in serum) at Screening must be negative in women of childbearing potential; 2. Female subjects of childbearing potential and not using a highly effective method of birth control during the study and for 30 days after final study drug administration.Male subjects (unless surgically sterile) with female spouses/partners who are of childbearing potential, and not using a barrier method of contraception during the study and for 30 days after final study drug administration. In addition, female spouses/partners of male subjects and who are of childbearing potential should also use a highly effective method of birth control during the study and for 30 days after final study drug administration. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. 3. In the opinion of the Investigator, the subject has clinically significant bladder outflow obstruction at risk of urinary retention; 4. Subject has significant PVR volume (> 150 mL); 5. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the Investigator (for female subjects confirmed by the cough provocation test [Appendix 4]); 6. Subject has a neurological cause for detrusor overactivity; 7. Subject has an indwelling catheter or practices intermittent self-catheterization; 8. Subject has diabetic neuropathy; 9. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs; 10. Subject has had previous lower urinary tract or pelvic floor surgery (except cystoscopy); 11. Subject has had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin; 12. Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis or Crohn*s Disease, toxic megacolon, myasthenia gravis or any other condition which makes the use of anticholinergics contraindicated; 13. Subject has clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Screening, such as myocardial infarction, uncontrolled angina, significant ventricular arrhythmias, heart failure and stroke; 14. Subject is receiving current non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to Screening); 15. Subject is using medications intended to treat OAB or prohibited medications. Subject is excluded if using restricted medications under conditions different to those specified in the 'Concomitant Medication' section; 16. Subject has known or suspected hypersensitivity to solifenacin succinate, mirabegron or any of their excipients; 17. Subject has any significant neurological disease or defect affecting bladder function (e.g., neurogenic bladder, systemic or central neurological disease such as MS and Parkinson*s disease); 18. Subject has severe hypertension which is defined as a sitting average systolic blood pressure * 180 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in mean volume voided per micturition after 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary efficacy variables: * Change from baseline in mean number of micturitions/24 h * Change from baseline in mean number of incontinence episodes/24 h Other secondary efficacy variables: * Change from baseline in mean volume voided per micturition at secondary time points(i.e., after 2, 4 and 8 weeks of treatment) * Change from baseline in mean number of urgency incontinence episodes/24 h * Change from baseline in mean number of urgency episodes (grade 3 and/or 4)/24 h (PPIUS scale) * Change from baseline in mean level of urgency * Change from baseline in Patient Perception of Bladder Condition (PPBC) * Change from baseline in symptom bother and health related quality of life scores asassessed by the Overactive Bladder Questionnaire (OAB-q) * Change from baseline in scores as assessed by European Quality of Life questionnaire in 5 Dimensions (EQ-5D) questionnaire * Change from baseline in scores as assessed by the Work Productivity and Activity Impairment: Specific Health Problem (WPAI:SHP) questionnaire * Change from baseline in the subject's assessment of Treatment Satisfaction (TS-VAS) * Change from baseline in mean number of incontinence pads used/24 h * Change from baseline in mean number of nocturia episodes/24 h Safety and Tolerability Variables * Incidence and severity of all AEs * Vital signs: sitting systolic and diastolic blood pressure (BP) and pulse rate (PR) * Physical examination * Laboratory tests: hematology, biochemistry, urinalysis * ECG parameters * PVR volume | — |
Countries
Netherlands
Outcome results
None listed