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

Ananias Diokno

Status

Completed

Conditions

Urinary Incontinence, Stress

Urinary Incontinence, Urge

Treatments

Behavioral: Group Behavioral Treatment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02001714

2013-204

1R01AG043383-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

463 patients

Sex

Female

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female
Aged 55 years or older
Ability to understand, read and write English
Stress, urgency, or mixed urgency and stress urinary incontinence (UI) (by self report)
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.
Symptoms of three months duration or longer (on history)
Passing score (i.e., categorized as "probably not demented") on the MiniCog Test
Timed "Up and Go" Test (TUG) score of 20 seconds or less
Willing to undergo vaginal/pelvic examination
Signed informed consent form

Exclusion criteria

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)
Non-ambulatory (participant confined to bed or wheelchair)
Persistent pelvic pain (defined as daily pelvic pain > 3 months)
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)
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)
Currently taking urinary incontinence or overactive bladder medications
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)
Participation in any drug/device research study.
Pelvic organ prolapse protruding past the introitus (at rest or persisting after strain)
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.
History of 2 or more recurrent UTI's within the past year; more than one UTI within past 6 months
Post void residual urine volume 150 cc or more.
Unstable medical condition (as determined by site PI)