Clinical Trials Directory

Trials / Terminated

TerminatedNCT04122898

Pelvic Floor Muscle Training in Gymnasts With Stress Urinary Incontinence

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

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
4 (actual)
Sponsor
Norwegian School of Sport Sciences · Academic / Other
Sex
Female
Age
12 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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). Based on today's knowledge we do not know whether PFM training is effective in elite athletes exposed to excessive impact in sports including elements of acrobatics and jumping. Given the high impact on the pelvic floor in these athletes, it is presumed that they need much better pelvic floor muscle function than non-exercisers. On the other hand, elite athletes are highly motivated for regular training. Strength training of the PFM, if proven effective, may be easily incorporated in their basic training regimens both as prevention and treatment strategies of SUI. AIMS: The aim of this RCT is to assess the effect of PFM training on symptoms, bother and amount of SUI among female artistic gymnasts, team gymnasts and cheerleaders. STUDY DESIGN AND METHODS: A cross-sectional study will be conducted to assess prevalence of SUI among female artistic gymnasts, team gymnasts and cheerleaders from 12 years of age competing on high national levels in Norway. Athletes reporting symptoms of SUI will be asked to participate in the RCT. The study is an assessor-blinded RCT evaluating the effect of PFM training on SUI in elite female gymnasts, team gymnasts and cheerleaders. At baseline, all athletes will perform a pad weight-test, measuring the amount of leakage during gymnastic and acrobatic activities. In addition, the athletes will respond to a standardized questionnaire, measuring self-reported symptoms of UI and bother. The athletes will be randomly assigned to either a PFM training group (EG) or a control group (CG) with no intervention. The intervention consists of a daily home-based PFM training program with weekly follow-up by a physiotherapist. After a three-months intervention period, all athletes will perform a post-test including the same previous mentioned outcome measures.

Conditions

Interventions

TypeNameDescription
OTHERPelvic Floor Muscle TrainingThe intervention will consist of a home-based PFM training program with weekly follow-up by phone by a physiotherapist. Before commencing PFM training, the gymnasts in the intervention group will have an individual session with a physiotherapist including thorough teaching on how to perform a correct PFM contraction (inward lift of the pelvic floor assessed with suprapubic 2D ultrasound) and instructions on how to perform the training program. The athletes will be offered at least one individual follow-up session with the same physiotherapist during the intervention period. The program will consist of 3 sets of 8-12 maximum contractions per day. An electronic app (Athlete monitoring) will be used to assess adherence to the program. The athletes will be asked to register their training sessions in a personal account. A reminder to adhere to the program will be sent by phone. The training period will be 3 months and the exercises will take approximately 10 minutes per day to perform.

Timeline

Start date
2020-01-20
Primary completion
2020-08-19
Completion
2020-08-19
First posted
2019-10-10
Last updated
2022-04-05

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT04122898. Inclusion in this directory is not an endorsement.