The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
307
4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects.
Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.
University of Alabama
Birmingham, Alabama, United States
University of California
San Diego, California, United States
Loyola University Medical Center
Maywood, Illinois, United States
University of Maryland
Proportion of Women Who Meet Definition of Success
Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a \>70% reduction in number of incontinence episodes as compared to baseline.
Time frame: 8 months
Change in Incontinence Episodes
Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.
Time frame: Baseline and 10 weeks
Change in Voids Per Day
Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary
Time frame: baseline and 10 weeks
Symptom Distress
Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.
Time frame: baseline, 10 weeks and 8 months
Symptom Bother
Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.
Time frame: baseline, 10 weeks and 8 months
Satisfaction
Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"
Time frame: 10 weeks
Satisfaction
Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"
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Baltimore, Maryland, United States
Oakwood Hospital and Medical Center
Royal Oak, Michigan, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern
Dallas, Texas, United States
University of Texas Health Sciences Center
San Antonio, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Time frame: 8 months
Symptom Improvement
Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"
Time frame: 10 weeks
Symptom Improvement
Number of women who responded "much better" or "better" to question: "Overall, do you feel that you are much better, better, about the same, worse or much worse?"
Time frame: 8 months