Trial Outcomes & Findings for Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms (NCT NCT02001714)

Results Overview

The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

463 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2017-10-19

Participant Flow

Recruitment letters were mailed to women 55 years and older seeking women with urinary incontinence who were treatment naïve. Those that met preliminary screening criteria, done at the administrative site, were referred to one of the three clinical sites (Alabama, Michigan or Pennsylvania) for final screening and enrollment .

Participant milestones

Participant milestones
Measure	Group Behavioral Treatment Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.	No Treatment Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
Overall Study STARTED	232	231
Overall Study COMPLETED	210	219
Overall Study NOT COMPLETED	22	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group Behavioral Treatment n=232 Participants Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.	No Treatment n=231 Participants Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.	Total n=463 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 6.8 • n=5 Participants	65 years STANDARD_DEVIATION 7.7 • n=7 Participants	64 years STANDARD_DEVIATION 7.3 • n=5 Participants
Sex: Female, Male Female	232 Participants n=5 Participants	231 Participants n=7 Participants	463 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 3 months

Population: The Group Behavioral Treatment group population at baseline is 232. At the 3 month follow-up visit 16 had withdrawn and 7 missed the appointment, leaving 209 for the total number analyzed. For the No Treatment group, the number at baseline is 231 and by the 3 month visit 8 had withdrawn and another 11 missed the appointment, leaving 212.

The primary outcome is the self-reported urinary incontinence severity as measured by the International Consultation on Incontinence questionnaire-short form (ICI-Q). This short and simple questionnaire is used to screen for incontinence (urine leakage) to obtain a brief yet comprehensive summary of the level, impact and perceived cause of symptoms of incontinence. The ICI-Q consists of four questions and numeric scales: 1. How much do you leak urine? (0-5); never - all the time, 2. How much urine do you usually leak? (0-6); none - large amount, 3. Overall, how much does leaking urine interfere with your everyday life? (0-10); not at all - a great deal, 4. When does urine leak? Multiple choices. The ICI-Q score is the sum of questions 1-3 and ranges from 0-21. The higher the score, the greater severity of incontinence. Baseline data is compared to the 3 month data for the primary outcome.

Outcome measures

Outcome measures
Measure	Group Behavioral Treatment n=209 Participants Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.	No Treatment n=212 Participants Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.	-2 units on a scale Interval -4.0 to 0.0	-1 units on a scale Interval -2.0 to 1.0

SECONDARY outcome

Timeframe: 12 months

Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.

Outcome measures

Outcome data not reported

Adverse Events

Group Behavioral Treatment

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Group Behavioral Treatment n=232 participants at risk Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.	No Treatment n=231 participants at risk Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
Cardiac disorders Arrhythmia	0.43% 1/232 • Number of events 1 • Adverse event data was collected from enrollment through the one year follow-up visit.	0.00% 0/231 • Adverse event data was collected from enrollment through the one year follow-up visit.

Other adverse events

Other adverse events
Measure	Group Behavioral Treatment n=232 participants at risk Participants will attend a group behavioral treatment class and follow-up visits. Group Behavioral Treatment: Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.	No Treatment n=231 participants at risk Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
Infections and infestations Urinary Tract Infection	2.2% 5/232 • Number of events 5 • Adverse event data was collected from enrollment through the one year follow-up visit.	2.6% 6/231 • Number of events 6 • Adverse event data was collected from enrollment through the one year follow-up visit.

Additional Information

Ananias C. Diokno, MD

Beaumont Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place