This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin S… (NCT01972841) | Clinical Trial Compass
CompletedPhase 3
This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder
United States3,527 participantsStarted 2013-11-05
Plain-language summary
The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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;
* Subject had symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months;
Exclusion Criteria:
* Subject had significant PVR volume (\> 150 mL);
* Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion.
* Subject had an indwelling catheter or practices intermittent self catheterization.
* Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis.
* Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin.
* Subject had moderate to severe hepatic impairment
* Subject had severe renal impairment
* Subject had a clinically significant abnormal ECG
* Subject had a concurrent malignancy or history of cancer (except noninvasive…
What they're measuring
1
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Timeframe: Baseline and EoT (up to 12 weeks)
2
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours