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临床试验/NCT04122898
NCT04122898终止不适用

Effect of Pelvic Floor Muscles Training on Symptoms, Bother and Amount of Stress Urinary Incontinence in Female Gymnasts, Team Gymnasts and Cheerleaders. An Assessor Blinded Randomized Controlled Trial

Norwegian School of Sport Sciences2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2020年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
4
试验地点
2
主要终点
Pad-weight Stress Test for Stress Urinary Incontinence

研究概览

简要总结

There is a high prevalence of urinary incontinence (UI) among female athletes participating in high impact sports, such as artistic gymnastics, trampoline jumping and ball games. UI is defined as "the complaint of involuntary loss of urine". Stress urinary incontinence (SUI) is the most common type of UI and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or or sneezing or coughing". Urinary leakage during sport activities may affect the athletes' performance, cause bother, frustration and embarrassment and furthermore lead to avoidance and cessation of sport activities. Pelvic floor muscle (PFM) training is highly effective in treating SUI in the general female population. However, evidence of the effect of PFM training in elite athletes in high impact sports is sparse.

The purpose of this assessor-blinded randomized controlled trial (RCT) is to assess the effect of PFM training on symptoms, bother and amount of SUI in female artistic gymnasts, team gymnasts and cheerleaders.

详细描述

BACKGROUND:

Physical activity and exercise have well-known beneficial effects on several physical and psychological health outcomes. However, it has been proposed that regular participation in physical activity and exercise may lead to greater risk of developing pelvic floor dysfunctions (PFD) in women. The pelvic floor consists of muscles, fascia and ligaments and forms a hammock-like support at the base of the abdomino-pelvic cavity. The function of the pelvic floor is to provide support to the pelvic organs (the bladder, urethra, vagina, uterus and rectum) and to counteract all increases in intra-abdominal pressure and ground reactions forces during daily activities. Additionally, the pelvic floor facilitates intercourse, vaginal birth, storage of stool and urine and voluntary defecation and urination. A dysfunctional pelvic floor can lead to urinary and anal incontinence, pelvic organ prolapse, sexual problems and chronic pain syndromes. UI is the most common PFD, defined as "the complaint of involuntary loss of urine". SUI, urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) are common subtypes of UI. In women, SUI accounts for approximately half of all incontinence types and is defined as "the complaint of involuntary loss of urine on effort or physical exertion (e.g. sporting activities), or on sneezing or coughing". UUI is defined as the "complaint of involuntary loss of urine associated with urgency" and MUI as "complaints of both stress and urgency urinary incontinence".

High prevalence rates of UI among both parous and nulliparous female athletes and exercisers have been reported in several cross-sectional studies. The prevalence rates varies between 0-80% with the highest prevalence found in high impact sports such as trampoline jumping, gymnastics and ball games. Leakage during sport activities may affect the athletes' performance and cause bother, frustration and embarrassment. Some athletes have reported that UI issues have also led to avoidance or cessation of sport or exercise.

To date, there is level 1 evidence and grade A recommendation for PFM training alone to be first line treatment for SUI, MUI and pelvic organ prolapse in the general female population. In addition, PFM training is highly effective as primary prevention; pregnant continent women who exercise the PFM are at 62% less risk of UI in late pregnancy and 29% less risk of UI 3-6 months postpartum. Evidence of the effect of PFM training in athletes or strenuous exercisers is sparse.

In one study on female soldiers and two small case series in female athletes and exercisers, PFM training led to reduced symptoms of UI. However, none of these studies included a non-treated control group and the internal validity is therefore low. To our knowledge, only one RCT has assessed effects of PFM training on SUI in athletes. Female volleyball players (n=16) who followed a PFM training program had significant improvements of SUI compared to a control group (n=16).

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
Single (Outcomes Assessor)

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female artistic gymnasts, team gymnasts and cheerleaders
  • eligible to compete in the Norwegian National Championship or competitions of higher levels
  • > 12 years of age
  • total score on ICIQ-UI-SF of >3
  • positive pad weight-test: >1 gram of leakage
  • self-reported SUI with ICIQ-UI-SF (urinary leakage during physical activity, exercise, sneezing or coughing)

排除标准

  • history of pregnancy, pelvic surgery, pelvic trauma, inflammatory bowel diseases or respiratory diseases/symptoms
  • male gymnasts
  • < 12 years of age
  • not eligible to competed in the Norwegian National Championship or competitions of higher levels
  • athletes who are unable to correctly contract the PFM, examined by suprapubic transabdominal 2D ultrasound

结局指标

主要结局

Pad-weight Stress Test for Stress Urinary Incontinence

时间窗: Change from baseline pad-test at three months

The test will be modified from the descriptions by Mørkved \& Bø, Eliasson, Larsson \& Mattson and Ferreira et al. The athletes will be requested to void 30 minutes before the test, to drink 0.5 liter of water and thereafter not empty their bladder. A pre-weighted pad will be applied, and the athletes will perform a 10 minutes intensive warm-up followed by 5 minutes of high impact gymnast- or cheerleading routines.

次要结局

  • The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF)(Change in total score from baseline at three months)
  • Patient Global Impression of Improvement (PGI-I) Scale(Post-test after a 3-months intervention period)
  • Self-Efficacy Scale for Practicing Pelvic Floor Exercises (SESPPFE)(At baseline in both groups. Athletes in the intervention group will also be asked to answer the questionnaire again within the first month of the intervention period.)

研究者

发起方
Norwegian School of Sport Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kari Bø

Professor

Norwegian School of Sport Sciences

研究点 (2)

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