Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms (Gladiolus)

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.

Study Overview

• Status: Completed
• Conditions: Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Intervention / Treatment: Behavioral: Group Behavioral Treatment

• Study Type: Interventional
• Enrollment (Actual): 463
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Birmingham VA Medical Cnter
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Health System, Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ananias Diokno
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Ananias C Diokno, MD, William Beaumont Hospitals

Publications and helpful links

General Publications

• Diokno AC, Newman DK, Low LK, Griebling TL, Maddens ME, Goode PS, Raghunathan TE, Subak LL, Sampselle CM, Boura JA, Robinson AE, McIntyre D, Burgio KL. Effect of Group-Administered Behavioral Treatment on Urinary Incontinence in Older Women: A Randomized Clinical Trial. JAMA Intern Med. 2018 Oct 1;178(10):1333-1341. doi: 10.1001/jamainternmed.2018.3766.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): December 1, 2016
• Study Completion (ACTUAL): December 1, 2016

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (ESTIMATE): December 5, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress; Urinary Incontinence, Urge
• Other Study ID Numbers: 2013-204; 1R01AG043383-01A1 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO