Gladiolus: Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

• Sponsor: Ananias Diokno (Other)
• Overall Status: Completed
• CT.gov ID: NCT02001714
• Collaborator: National Institute on Aging (NIA) (NIH)
• Enrollment: 463
• Locations: 4
• Arms: 2
• Actual Duration (Months): 39
• Patients Per Site: 115.8
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

This three-site randomized controlled trial compares the effectiveness and cost-effectiveness of a group-administered behavioral treatment program to no treatment. Women with stress, urgency, or mixed urinary incontinence will be recruited and screened centrally, evaluated clinically at each of three study sites, and random assigned to one of two treatment arms: 1. Group behavioral treatment or 2. No treatment. Group treatment modalities have the potential to reach a larger population of older women with urinary incontinence, not only in the traditional medical settings, but also in community settings. The investigators hypothesize that group behavioral treatment will be more effective than no treatment. The investigators hypothesize that the group treatment will be cost-effective compared to no treatment.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Stress; Urinary Incontinence, Urge	Behavioral: Group Behavioral Treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 463 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: The randomization schedule will be concealed so that investigators and staff at the sites will not be able to anticipate experimental group assignments. Evaluators at each site will be blind to group assignment throughout all assessments.
• Primary Purpose: Treatment
• Official Title: Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms
• Actual Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group Behavioral Treatment Participants will attend a group behavioral treatment class and follow-up visits.	Behavioral: 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 Intervention: No Treatment Subjects will not attend group behavioral treatment class.

Outcome Measures

Primary Outcome Measures

1. Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity. [Baseline and 3 months]

   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.

Secondary Outcome Measures

1. Group Behavioral Treatment Cost-effectiveness [12 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female

2. Aged 55 years or older

3. Ability to understand, read and write English

4. Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report)

5. On the International Consultation on Incontinence Modular Questionnaire - Short Form (ICIQ UI-SF), frequency of leakage at least a 1 ("about once a week or less often") on item #1 and volume of urine loss at least a 2 ("a small amount") on item #2.

6. Symptoms of three months duration or longer (on history)

7. Passing score (i.e., categorized as "probably not demented") on the MiniCog Test

8. Timed "Up and Go" Test (TUG) score of 20 seconds or less

9. Willing to undergo vaginal/pelvic examination

10. Signed informed consent form

Exclusion Criteria:

1. History of renal, bladder, uterine, ovarian, urethral, anal or rectal cancer, radiation therapy to the pelvis for any cancer/malignancy, or any active cancer/malignancy (except skin cancer)

2. Non-ambulatory (participant confined to bed or wheelchair)

3. Persistent pelvic pain (defined as daily pelvic pain > 3 months)

4. History of neurologic or end-stage diseases (e.g. cerebral vascular accident (CVA), Parkinson's disease, multiple sclerosis, epilepsy, spinal cord tumor or trauma, spina bifida, symptomatic herniated disc)

5. Previous treatment or current participation in a research study for UI, including surgery or formal behavioral treatment (pelvic floor muscle training, biofeedback, pelvic floor electrical stimulation, percutaneous tibial nerve stimulation, sacral neuromodulation, botox or other periurethral injection)

6. Currently taking urinary incontinence or overactive bladder medications

7. History of other urinary conditions or procedures that may affect continence status (e.g. urethral diverticula, previous augmentation cystoplasty or artificial urinary sphincter; implanted nerve stimulators for urinary symptoms)

8. Participation in any drug/device research study.

9. Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain)

10. Evidence of urinary tract infection (UTI) by urine dipstick (leukocytes +1 or greater, nitrites +1 or greater, leukocytes alone (w/o nitrites) +2 or greater, or presence of hematuria > +1). Participants may be re-screened after treatment with antibiotics or if hematuria work-up is negative.

11. History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months

12. Post void residual urine volume 150 cc or more.

13. Unstable medical condition (as determined by site PI)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham VA Medical Cnter	Birmingham	Alabama	United States	35233
2	University of Michigan	Ann Arbor	Michigan	United States	48109
3	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
4	University of Pennsylvania Health System, Urology	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Ananias Diokno
• National Institute on Aging (NIA)

Investigators

• Principal Investigator: Ananias C Diokno, MD, William Beaumont Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ananias Diokno, Principal Investigator, William Beaumont Hospitals
• ClinicalTrials.gov Identifier: NCT02001714
• Other Study ID Numbers: 2013-204; 1R01AG043383-01A1
• First Posted: Dec 5, 2013
• Last Update Posted: Oct 19, 2017
• Last Verified: Oct 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge

Study Results

Participant Flow

Recruitment Details	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 .

Arm/Group Title	Group Behavioral Treatment	No Treatment
Arm/Group Description	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.	Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
Period Title: Overall Study
STARTED	232	231
COMPLETED	210	219
NOT COMPLETED	22	12

Baseline Characteristics

Arm/Group Title	Group Behavioral Treatment	No Treatment	Total
Arm/Group Description	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.	Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.	Total of all reporting groups
Overall Participants	232	231	463
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	64 (6.8)	65 (7.7)	64 (7.3)
Sex: Female, Male (Count of Participants)
Female	232 100%	231 100%	463 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Group Behavioral Treatment	No Treatment
Arm/Group Description	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.	Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
Measure Participants	209	212
Median (Inter-Quartile Range) [units on a scale]	-2	-1

2. Secondary Outcome

Title	Group Behavioral Treatment Cost-effectiveness
Description	Measure resource use and utilities and compare the difference in incontinence management costs and utilities between treatment and control group.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	Adverse event data was collected from enrollment through the one year follow-up visit.
Arm/Group Title	Group Behavioral Treatment		No Treatment
Arm/Group Description	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.		Subjects will not attend group behavioral treatment class but have the same follow-up visit schedule. Subjects will receive the same handout.
All Cause Mortality
	Group Behavioral Treatment		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Group Behavioral Treatment		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/232 (0.4%)		0/231 (0%)
Cardiac disorders
Arrhythmia	1/232 (0.4%)	1	0/231 (0%)	0
Other (Not Including Serious) Adverse Events
	Group Behavioral Treatment		No Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/232 (2.2%)		6/231 (2.6%)
Infections and infestations
Urinary Tract Infection	5/232 (2.2%)	5	6/231 (2.6%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.