Group Learning Achieves Decreased Incidents of Lower Urinary Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 463
- 试验地点
- 4
- 主要终点
- Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The randomization schedule will be concealed so that investigators and staff at the sites will not be able to anticipate experimental group assignments. Evaluators at each site will be blind to group assignment throughout all assessments.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 #
- •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
排除标准
- •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)
研究组 & 干预措施
Group Behavioral Treatment
Participants will attend a group behavioral treatment class and follow-up visits.
干预措施: Group Behavioral Treatment (Behavioral)
No Treatment
Subjects will not attend group behavioral treatment class.
结局指标
主要结局
Group Behavioral Treatment Effectiveness as Shown by Changes From Baseline to 3 Months in Urinary Incontinence Severity.
时间窗: 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.
次要结局
- Group Behavioral Treatment Cost-effectiveness(12 months)
研究者
Ananias Diokno
Principal Investigator
William Beaumont Hospitals