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OpenTrials
Completed

NCT Number: NCT02001714

Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms

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.

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Key information

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham VA Medical Cnter, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

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Treatment and study plan

Group Behavioral Treatment

Behavioral

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Group Behavioral Treatment Cost-effectiveness

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Ananias Diokno

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: Gladiolus

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 5, 2013
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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