Overview

This trial is active, not recruiting.

Conditions urinary incontinence, stress, urinary incontinence, urge
Treatment group behavioral treatment
Sponsor Ananias Diokno
Collaborator National Institute on Aging (NIA)
Start date September 2013
End date June 2017
Trial size 465 participants
Trial identifier NCT02001714, 1R01AG043383-01A1, 2013-204

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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 Intervention)
Subjects will not attend group behavioral treatment class.

Primary Outcomes

Measure
Group Behavioral Treatment Effectiveness as shown by changes in urinary incontinence severity.
time frame: 3, 6, 9 and 12 months

Secondary Outcomes

Measure
Group Behavioral Treatment cost-effectiveness
time frame: 12 months

Eligibility Criteria

Female participants at least 55 years old.

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)

Additional Information

Official title Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms
Principal investigator Ananias C Diokno, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by William Beaumont Hospitals.