A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder
Condition: Urinary Bladder Overactive; Overactive Bladder; Urgency Incontinence; Urinary Bladder Diseases\Urologic Diseases
MeSH terms: Urinary Bladder, Overactive; Urologic Diseases; Urinary Bladder Diseases
Intervention: Solifenacin succinate; Mirabegron; Placebo to match solifenacin; Placebo to match mirabegron
Intervention description: Participants received solifenacin 5 mg orally once a day at the same time each day.; Participants received mirabegron 50 mg orally once a day at the same time each day.; Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.; Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
Intervention MeSH terms: Mirabegron; Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1829.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Solifenacin Succinate; Mirabegron; Urinary Incontinence; Combination Therapy; Urgency; Nocturia; Overactive Bladder

Summary:

      The purpose of this study was to examine how well the combination of two medicines
      (solifenacin succinate and mirabegron) worked compared to each medicine alone in the
      treatment of bladder problems, and how safe they were for long term use.
    

Eligibility criteria:

        Inclusion Criteria:

        Main Inclusion at Screening (Visit 1):

          -  Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion
             would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012
             had been completed. In that case the subject had to have symptoms of "wet" OAB
             (urinary frequency and urgency with incontinence) for at least 3 months);

          -  Subject was willing and able to complete the micturition diary and questionnaires
             correctly 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;

        Main Inclusion at Randomization (Visit 2):

          -  Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during
             the last 7 days of the micturition diary period (incontinence episode should not be
             counted as a micturition).

          -  Subject had experienced at least 3 incontinence episodes during the last 7 days of the
             micturition diary period.

          -  Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient
             Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period during the 7-day
             micturition diary period.

        Exclusion Criteria:

        Main Exclusion at Screening (Visit 1):

          -  Subject had clinically significant bladder outflow obstruction at risk of urinary
             retention;

          -  Subject had significant PVR volume (> 150 mL);

          -  Subject had significant stress incontinence or mixed stress/urgency incontinence where
             stress is the predominant factor;

          -  Subject has an indwelling catheter or practices intermittent self-catheterization;

          -  Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronic
             inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation
             therapy or previous or current malignant disease of the pelvic organs;

          -  Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin,
             resiniferatoxin, capsaicin;

        Main Exclusion at Randomization (Visit 2):

          -  Subject had evidence of a urinary tract infection (UTI) (urine culture containing >
             100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be
             rescreened after successful treatment of the UTI (confirmed by a dipstick negative for
             nitrite).

          -  Subject had an average total daily urine volume > 3000 mL as recorded in the
             micturition diary period.