Efficacy of Acupuncture in Treating Urinary Incontinence
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Percent Change in Incontinent Episodes
研究概览
简要总结
This research study will evaluate the effectiveness of acupuncture in decreasing urinary incontinence (involuntary urine loss) in women. The study will involve 12 acupuncture sessions over 6 weeks. We will compare the effectiveness of acupuncture and sham (placebo) acupuncture (a procedure in which the needle feels like it penetrates the skin, but is not actually inserted into the body) on the frequency and volume of involuntary (accidental) urine loss after completing the intervention, and again one month later. Individuals participating in this study will be randomly assigned to receive either the actual or sham acupuncture. Randomization means being assigned by chance, similar to flipping a coin. Study participants will not know which group (actual or sham acupuncture) they were assigned to until one month after completing the 6-weeks of treatment. The sham acupuncture needles look similar to the real acupuncture needles and feel like they penetrate the skin, but do not actually do so. If individuals are assigned to the sham acupuncture group, they will be eligible to receive the actual acupuncture one month after completing the sham acupuncture if they wanted to. All individuals will be followed for 6 months after completing the acupuncture treatments.
详细描述
See Brief Summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Urge or stress urinary incontinence at least twice a week on average for at least 3 months
排除标准
- •History of previous acupuncture
- •History of a neurologic problem such as Parkinson's disease or multiple sclerosis that could affect bladder function
- •Current treatment with overactive bladder medications or medications that relax the bladder
- •Urinary catheter
- •Pregnancy
- •Inability to empty the bladder effectively
- •Inability to toilet independently
- •Current treatment with steroid
- •Interstitial cystitis
- •Chronic pelvic pain
- •Current treatment with warfarin
研究组 & 干预措施
Acupuncture
Subjects will 12 acupuncture treatments over 6 weeks; treatment sessions occur twice a week. A total of 12 acupuncture needles will be inserted bilaterally at two leg points and four back points. Needles are manually inserted through a standard guide tube contained within a fitted sheath and the basal ring secured to the skin by double-sided tape. The needles remain in place for 25 minutes and are manually stimulated twice during each treatment.
干预措施: Acupuncture (Procedure)
Sham acupuncture
Subjects will receive 12 sham acupuncture treatments (delivered twice a week) over 6 weeks. The sham needle is blunted needle whose shaft telescopes into the handle when tapped. While the needle appears to have been inserted, it does not actually penetrate the skin. It is held in place by the same standard guide tube used in the true acupuncture group. The acupuncture points and duration of treatment are the same as for the true acupuncture group.
干预措施: Sham acupuncture (Other)
结局指标
主要结局
Percent Change in Incontinent Episodes
时间窗: 4 weeks post true or sham acupuncture
Percent change in incontinent episodes (measured by self-report electronic bladder diary) 4 weeks post true or sham acupuncture
Physical Health-Related Quality of Live
时间窗: 1 Week post-intervention
Percent change in physical health related quality of life measured at 1 week post-intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Higher SF-36 Physical Component scores are considered a better outcome.
Physical Health-Related Quality of Life
时间窗: 4-weeks post-intervention
Percent change in physical health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Physical Component score. Positive change indicates an increase in physical health-related quality of life.
Mental Health Related Quality of Life
时间窗: 4 weeks post true or sham acupuncture
Percent change in mental health related quality of life measured at 4 weeks post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score.
Incontinence-Specific Quality of Life
时间窗: 4-weeks post-intervention
Percent change in incontinence-specific quality of life a 4 weeks post-intervention (true or sham acupuncture) measured by the Incontinence Impact Questionnaire. Positive changes indicate improvement in incontinence-specific quality of life.
Duration of Any Beneficial Effects
时间窗: monthly during follow-up up to 6 months
Time to relapse in months of participants who completed true acupuncture initially or who crossed-over following sham (offered to all sham participants)
Percent Change in Incontinent Episodes
时间窗: Baseline to 1 Week post-intervention
Percent change in incontinent episodes (measured by self-report electronic bladder diary) at 1 week post-intervention (true or sham acupuncture) relative to baseline.
Mental Health Related Quality of Life
时间窗: 1 week post-intervention
Percent change in mental health related quality of life measured at 1 week1 post intervention (true or sham acupuncture) relative to baseline; measured by the Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component score. Higher Mental Health Component scores are considered a better outcome.
Incontinence-Specific Quality of Life
时间窗: 1 Week post-intervention
Percent change in incontinence specific quality of life at 1 week post intervention (true or sham acupuncture) as measured by the Incontinence Impact Questionnaire. Positive values indicate improvement in incontinence-specific quality of life.
次要结局
- Change in Bladder Capacity(Change from baseline to 4 weeks post-intervention)
- Urodynamic Diagnostic Impression of Stress Urinary Incontinence(Baseline and 4 weeks post-treatment)
- Urodynamic Impression of Urge Urinary Incontinence(Baseline and 4 weeks post true or sham acupuncture)
- Characteristics of Responders Based on Glasses/Cups Per Day of Non-caffeinated Fluids (Including Water)(Baseline)
- Characteristics of Responders: Duration of Urinary Incontinence (UI) in Years(Baseline)
- Adherence to Treatment Protocol(6 weeks)
- Burden Associated With the Acupuncture Treatment Protocol(1 week post-treatment)
- Need for Booster Acupuncture During Follow-up(Monthly during the 6 month follow-up period)
- Response to Booster Acupuncture if Needed(After the booster sessions)
- Pelvic Floor Muscle Strength(Baseline and 4 weeks post true or sham acupuncture)
- Pelvic Floor Muscle Strength(Baseline and 1 week post true or sham acupuncture)
研究者
Sandra Engberg
Professor and Associate Dean for Graduate Clinical Education
University of Pittsburgh