Clinical trial NCT02001714: Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms
Official title: Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence, Stress
Urinary Incontinence, Urge
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-12-05
Enrollment: 463
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

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Primary outcomes:
measure: Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Group Behavioral Treatment Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Cnter
state: Alabama
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System, Urology
state: Pennsylvania
Study officials:
affiliation: William Beaumont Hospitals
name: Ananias C Diokno, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.