Contin-RUN Study: Prevalence and Conservative Treatment of Urinary Incontinence in Female Runners
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Amount of urinary leakage during running
研究概览
简要总结
This study comprises two phases, each with distinct objectives. The first phase aims to investigate the prevalence of urinary incontinence and other pelvic floor dysfunctions in Brazilian female runners through structured questionnaires. The second phase aims to evaluate and compare the effectiveness of three different exercise regimens for the treatment of urinary incontinence in female runners. The intervention groups include: a) pelvic floor muscle training combined with abdominal training, b) hypopressive abdominal exercises, and c) pelvic floor muscle training alone. The primary outcome measure is the severity of urinary incontinence, which will be assessed using the adapted 1-hour pad test and a 3-day bladder diary. Secondary outcomes include symptoms of pelvic floor dysfunction and pelvic floor muscle function. The intervention will last for 12 weeks, after which participants will be reassessed to determine which training regimen is most effective in treating urinary incontinence in female runners.
详细描述
This study has two stages with distinct objectives. The first stage aims to investigate the prevalence of urinary incontinence and other pelvic floor dysfunctions in Brazilian female runners. To achieve this goal, a survey will be conducted using a questionnaire, which will include questions about demographic data, general gynecological and obstetric health (menopause, pregnancies, deliveries), training specifics (weekly volume, time spent running, practice of other exercises, how the training is conducted), and questions related to pelvic floor dysfunctions (urinary incontinence, fecal incontinence, sexual dysfunctions, and symptoms of genital prolapse). For this study, it is estimated that at least 400 female runners will respond to the questionnaire.
The second stage aims to compare three types of exercise programs for the treatment of urinary incontinence in runners: (1) pelvic floor muscle training combined with abdominal training; (2) hypopressive abdominal gymnastics; or (3) pelvic floor muscle training. The primary outcome of interest is the severity of urinary loss, assessed by a 1-hour adapted pad test and a 3-day voiding diary. Secondary outcomes will include symptoms related to urinary incontinence and other dysfunctions. For this purpose, the International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and Pelvic Floor Distress Inventory (PFDI-20) will be used. Lastly, pelvic floor muscle function will be assessed through vaginal palpation, quantified using the Oxford scale, and through vaginal manometry. After agreeing to participate and signing the informed consent form, the women will be evaluated and then randomized into one of the three previously described groups. The exercises will be performed over a 12-week period. The women will then be re-evaluated. A sample size calculation was performed, and 40 participants will be required in each group to verify the superiority of one type of exercise over the others.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants must have been running for at least six months
- •Run at least 15 kilometers per week,
- •Have no injuries that have prevented them from running for more than three weeks in the past six months
- •Experience involuntary urinary leakage during running
- •The women must have a pelvic floor muscle strength of ≥ 2 on the modified Oxford scale
排除标准
- •Having a diagnosed neuromuscular disease that affects bladder function
- •Having undergone previous pelvic or perineal surgeries for the correction of pelvic floor dysfunctions
- •Having previously received physical therapy for the treatment of pelvic floor dysfunctions
研究组 & 干预措施
1PFMT + Abd Group
Participants in this group will perform pelvic floor muscle training in conjunction with abdominal muscle training. It is believed that abdominal contraction will lead to an increase in abdominal pressure, which will serve as additional load for pelvic floor muscle training.
干预措施: Pelvic floor and abdominal training (Behavioral)
AHG Group
Participants in this group will perform Hypopressive Abdominal Gymnastics exercises (Caufriez, 1997). It is believed that these exercises reduce the pressure on the pelvic floor muscles and help tone this musculature without causing harm.
干预措施: Abdominal Hypopressive Technique Exercises (Behavioral)
PFMT Group
Participants of PFMT group will perform specific exercises for the pelvic floor muscles, with maximum contraction and without involvement of other muscle groups. This arm is considered the control group because it is the treatment that has been proven to effectively treat urinary incontinence, as demonstrated in over 50 clinical trials.
干预措施: Pelvic floor muscle training (Other)
结局指标
主要结局
Amount of urinary leakage during running
时间窗: From enrollment to the end of the treatment at 12 weeks
The severity of urinary incontinence is the primary outcome of interest. The amount of urinary leakage will be assessed using a modified 1-hour pad test. The pad test will be performed on a treadmill. The participant will drink 500 ml of water in 15 minutes, wait another 15 minutes in rest, place a pre-weighed pad in her underwear, and then run continuously for 40 minutes on the treadmill at a comfortable speed of her choice. After the running period, the pad will be removed and weighed to determine the amount of urinary leakage in grams.
次要结局
- Frequency of urinary leakage(From enrollment to the end of the treatment at 12 weeks)
- Other pelvic floor dysfunction symptoms(From enrollment to the end of the treatment at 12 weeks)
- Pelvic floor muscle strength(From enrollment to the end of the treatment at 12 weeks)
- Pelvic floor manometry(From enrollment to the end of the treatment at 12 weeks)
- Impact of urinary incontinence in the quality of life(From enrollment to the end of the treatment at 12 weeks)
研究者
Ana Paula Magalhães Resende
Clinical Professor Ana Paula M. Resende, PT, PhD, Principal Investigator
Federal University of Uberlandia