Pelvic Floor Muscle Training in Gymnasts With Stress Urinary Incontinence

NCT04122898 | Terminated

• 1 other identifier: KLS2019
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urinary Incontinence; Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Pad-weight Stress Test for Stress Urinary Incontinence

  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.

  Change from baseline pad-test at three months

Secondary Outcomes (3)

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Three months home-based PFM training program with weekly follow-up by a physiotherapist

Other: Pelvic Floor Muscle Training

Control Group

NO INTERVENTION

No intervention

Interventions

Pelvic Floor Muscle Training OTHER

The 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.

Also known as: Pelvic Floor Muscle Training in Elite Gymnasts

Intervention Group

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead

Study Sites (1)

Norwegian School of Sport Sciences, Department of Sport Medicine

Oslo, 0863, Norway

Location

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MeSH Terms

Conditions

Urinary Incontinence; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kari Bø, PhD

  Norwegian School of School of Sport Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 10, 2019
• Study Start: January 20, 2020
• Primary Completion: August 19, 2020
• Study Completion: August 19, 2020
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)