A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (S… (NCT01908829) | Clinical Trial Compass
CompletedPhase 3
A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)
United States2,174 participantsStarted 2013-07-10
Plain-language summary
The purpose of this study was to see if adding a new type of medication recently approved to treat overactive bladder (mirabegron) to an antimuscarinic treatment (solifenacin) would be more effective in controlling incontinence than when using the antimuscarinic treatment alone.
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 has symptoms of OAB (urinary frequency and urgency with urgency incontinence) for \>= 3 months prior to the screening visit
✓. Subject is willing and able to complete the micturition diary and questionnaires correctly, including collection and measurement of urine output for 3 days prior to each visit;
✓. Subject has symptoms of "wet" OAB (urinary frequency and urgency with incontinence or mixed incontinence with predominant urgency incontinence), and reports an average of at least 2 incontinence episodes per day.
✓. Subject experiences on average at least 1 episode of urgency (grade 3 or 4) with or without incontinence per 24-hour period during the 3-day micturition diary period.
✓. Subject experiences on average at least 2 incontinence episodes per 24-hour period during the 3-day micturition diary period.
✓. Subject experiences on average at least 8 micturitions (excluding incontinence episodes) per 24-hour period during the 3-day micturition diary period.
✓. Subject experiences at least 1 incontinence episode during the 3-day micturition diary period and wishes to increase their treatment for OAB symptoms.
Exclusion criteria
✕. Subject in the opinion of the investigator has clinically significant Bladder Outlet Obstruction (BOO).
✕. Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator
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 end of treatment (up to 12 weeks)
✕. Subject has an indwelling catheter or practices intermittent self catheterization.
✕. Subject has evidence of a UTI.
✕. Subject has chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy, or previous or current malignant disease of the pelvic organs
✕. Subject has moderate to severe hepatic impairment
✕. Subject has severe renal impairment or End Stage Renal disease