Trial Outcomes & Findings for Behavior Enhances Drug Reduction of Incontinence (BE-DRI) (NCT NCT00090584)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

307 participants

Primary outcome timeframe

8 months

Results posted on

2013-06-17

Participant Flow

Between July, 2004 and January, 2006 4,043 women were screened for eligibility and 561 provided written consent. After further screening, 134 were found to be ineligible, 119 withdrew consent and 1 was excluded erroneously. The remaining 307 were randomized to one of the treatment arms.

Of the 134 found to be ineligible after consent, for 77 their urinary incontinence (UI) was not urge predominant, 19 had fewer than 7 episodes of incontinence per week and the other 38 were excluded for a variety of reasons.

Participant milestones

Participant milestones
Measure	Combination Therapy Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
Baseline to 10 Weeks STARTED	154	153
Baseline to 10 Weeks COMPLETED	139	141
Baseline to 10 Weeks NOT COMPLETED	15	12
Baseline to 8 Months STARTED	154	153
Baseline to 8 Months COMPLETED	110	112
Baseline to 8 Months NOT COMPLETED	44	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination Therapy Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
Baseline to 10 Weeks Lost to Follow-up	15	12
Baseline to 8 Months Lost to Follow-up	44	41

Baseline Characteristics

Behavior Enhances Drug Reduction of Incontinence (BE-DRI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination Therapy n=154 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=153 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Total n=307 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	112 Participants n=99 Participants	106 Participants n=107 Participants	218 Participants n=206 Participants
Age, Categorical >=65 years	42 Participants n=99 Participants	47 Participants n=107 Participants	89 Participants n=206 Participants
Age Continuous	55.8 years STANDARD_DEVIATION 14.2 • n=99 Participants	58.0 years STANDARD_DEVIATION 13.5 • n=107 Participants	56.9 years STANDARD_DEVIATION 13.9 • n=206 Participants
Sex: Female, Male Female	154 Participants n=99 Participants	153 Participants n=107 Participants	307 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	154 participants n=99 Participants	153 participants n=107 Participants	307 participants n=206 Participants

PRIMARY outcome

Timeframe: 8 months

Population: All women who completed the 8 months assessment or were known to return to drug use prior to that time.

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.

Outcome measures

Outcome measures
Measure	Combination Therapy n=118 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=119 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months 8 months value from women in combination arm	Drug Only at Baseline Baseline value for women randomized to drug only	Drug Only at 10 Weeks 10 week value for women randomized to drug only	Drug Only at 8 Months 8 month value for women randomized to drug only
Proportion of Women Who Meet Definition of Success	43 participants	41 participants	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 10 weeks

Population: All women with valid bladder diary at baseline and 10 weeks in each treatment group.

Change from baseline to 10 weeks in number of incontinence episodes per week as reported on bladder diary.

Outcome measures

Outcome measures
Measure	Combination Therapy n=133 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=136 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months 8 months value from women in combination arm	Drug Only at Baseline Baseline value for women randomized to drug only	Drug Only at 10 Weeks 10 week value for women randomized to drug only	Drug Only at 8 Months 8 month value for women randomized to drug only
Change in Incontinence Episodes	-20.4 incontinence episodes per week Standard Error 1.4	-18.5 incontinence episodes per week Standard Error 1.4	—	—	—	—

SECONDARY outcome

Timeframe: baseline and 10 weeks

Population: All women with valid bladder diary at baseline and 10 weeks in each treatment group.

Change from baseline to 10 weeks in frequency of voids per day as reported on bladder diary

Outcome measures

Outcome measures
Measure	Combination Therapy n=133 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=136 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months 8 months value from women in combination arm	Drug Only at Baseline Baseline value for women randomized to drug only	Drug Only at 10 Weeks 10 week value for women randomized to drug only	Drug Only at 8 Months 8 month value for women randomized to drug only
Change in Voids Per Day	-0.5 voids per day Standard Error 0.4	0.3 voids per day Standard Error 0.3	—	—	—	—

SECONDARY outcome

Timeframe: baseline, 10 weeks and 8 months

Population: All women who completed UDI at each time in each treatment group

Urogenital distress inventory (UDI). Higher score indicates greater distress. Possible range 0 to 300.

Outcome measures

Outcome measures
Measure	Combination Therapy n=154 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=133 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months n=109 Participants 8 months value from women in combination arm	Drug Only at Baseline n=153 Participants Baseline value for women randomized to drug only	Drug Only at 10 Weeks n=136 Participants 10 week value for women randomized to drug only	Drug Only at 8 Months n=111 Participants 8 month value for women randomized to drug only
Symptom Distress	121.4 units on a scale Standard Deviation 3.8	47.3 units on a scale Standard Deviation 4.1	61.9 units on a scale Standard Deviation 4.3	118.2 units on a scale Standard Deviation 3.9	58.1 units on a scale Standard Deviation 4.0	83.3 units on a scale Standard Deviation 4.2

SECONDARY outcome

Timeframe: baseline, 10 weeks and 8 months

Population: Participants who completed OAB-q assessment at each time in each treatment group.

Disease specific overactive bladder scale (OAB-q). HIgher score indicates greater bother. Possible range 0 to 100.

Outcome measures

Outcome measures
Measure	Combination Therapy n=154 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=133 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months n=109 Participants 8 months value from women in combination arm	Drug Only at Baseline n=153 Participants Baseline value for women randomized to drug only	Drug Only at 10 Weeks n=136 Participants 10 week value for women randomized to drug only	Drug Only at 8 Months n=111 Participants 8 month value for women randomized to drug only
Symptom Bother	59.9 units on a scale Standard Deviation 1.7	23.1 units on a scale Standard Deviation 1.8	29.0 units on a scale Standard Deviation 1.9	60.0 units on a scale Standard Deviation 1.7	29.6 units on a scale Standard Deviation 1.7	39.6 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: 10 weeks

Population: Number of women who completed satisfaction question at 10 weeks.

Number of women who responded "completely satisfied" to question, "How satisfied are you with your progress?"

Outcome measures

Outcome measures
Measure	Combination Therapy n=134 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=138 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months 8 months value from women in combination arm	Drug Only at Baseline Baseline value for women randomized to drug only	Drug Only at 10 Weeks 10 week value for women randomized to drug only	Drug Only at 8 Months 8 month value for women randomized to drug only
Satisfaction	71 participants	55 participants	—	—	—	—

SECONDARY outcome

Timeframe: 8 months

Population: Number of participants who completed the 8 months satisfaction questions

Number of women who responded "completely satisfied" to question "How satisfied are you with your progress?"

Outcome measures

Outcome measures
Measure	Combination Therapy n=115 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=123 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months 8 months value from women in combination arm	Drug Only at Baseline Baseline value for women randomized to drug only	Drug Only at 10 Weeks 10 week value for women randomized to drug only	Drug Only at 8 Months 8 month value for women randomized to drug only
Satisfaction	38 participants	25 participants	—	—	—	—

SECONDARY outcome

Timeframe: 10 weeks

Population: Participants who completed the satisfaction item at 10 weeks.

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?"

Outcome measures

Outcome measures
Measure	Combination Therapy n=134 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=138 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months 8 months value from women in combination arm	Drug Only at Baseline Baseline value for women randomized to drug only	Drug Only at 10 Weeks 10 week value for women randomized to drug only	Drug Only at 8 Months 8 month value for women randomized to drug only
Symptom Improvement	120 participants	106 participants	—	—	—	—

SECONDARY outcome

Timeframe: 8 months

Population: Participants who completed the perceived improvement item at 8 months.

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?"

Outcome measures

Outcome measures
Measure	Combination Therapy n=116 Participants Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=125 Participants Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.	Combiniation at 8 Months 8 months value from women in combination arm	Drug Only at Baseline Baseline value for women randomized to drug only	Drug Only at 10 Weeks 10 week value for women randomized to drug only	Drug Only at 8 Months 8 month value for women randomized to drug only
Symptom Improvement	80 participants	54 participants	—	—	—	—

Adverse Events

Combination Therapy

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Drug Therapy Alone

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Combination Therapy n=154 participants at risk Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=153 participants at risk Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
Cardiac disorders Tachycardia	0.65% 1/154 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).	0.00% 0/153 • Participants were monitored for adverse events throughout the study period (8 months).
Gastrointestinal disorders Small bowl obstruction	0.65% 1/154 • Number of events 2 • Participants were monitored for adverse events throughout the study period (8 months).	0.65% 1/153 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).
Renal and urinary disorders Renal cell carcinoma	0.00% 0/154 • Participants were monitored for adverse events throughout the study period (8 months).	0.65% 1/153 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).

Other adverse events

Other adverse events
Measure	Combination Therapy n=154 participants at risk Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.	Drug Therapy Alone n=153 participants at risk Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
Eye disorders Glaucoma	0.65% 1/154 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).	0.00% 0/153 • Participants were monitored for adverse events throughout the study period (8 months).
Renal and urinary disorders Peripheral edema	0.00% 0/154 • Participants were monitored for adverse events throughout the study period (8 months).	0.65% 1/153 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).
Cardiac disorders Syncopal episode	0.65% 1/154 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).	0.00% 0/153 • Participants were monitored for adverse events throughout the study period (8 months).
Renal and urinary disorders Night sweats	0.65% 1/154 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).	0.00% 0/153 • Participants were monitored for adverse events throughout the study period (8 months).
Gastrointestinal disorders Stomach cramping	0.65% 1/154 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).	0.00% 0/153 • Participants were monitored for adverse events throughout the study period (8 months).
Musculoskeletal and connective tissue disorders Weakness	0.65% 1/154 • Number of events 1 • Participants were monitored for adverse events throughout the study period (8 months).	0.00% 0/153 • Participants were monitored for adverse events throughout the study period (8 months).

Additional Information

Anne Stoddard, ScD

New England Research Institutes

Phone: 617-972-3331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place