Impact of a 12-Week Pelvic Floor Training on Urinary Incontinence in Functional Fitness Training Athletes (PFMT-UI-FFT)

Functional fitness training (FFT) is a prominent exercise regimen, that has emerged as the dominant fitness trend of the 21st century , advocating high-intensity exercises with repetitive, impactful movements that often result in increased intra-abdominal pressure (IAP) and neuromuscular fatigue. This demanding training pattern, characterized by minimal rest pauses, has been associated with potential health concerns, particularly urinary incontinence (UI). In athletes, UI is intricately connected to the frequency of exposure to increased IAP during high-impact activities. These activities assume even greater significance in sports, particularly in FFT, where there is an increased frequency of impactful foot contact on the ground and intensive abdominal exercises, potentially correlating with the overload of the pelvic floor muscles and the emergence of dysfunctions. Therefore, this study aims to examine the effects of a 12-week training program focused on Kegel exercises performed with diaphragmatic breathing in nulliparous female FFT athletes. The central hypothesis postulates that after the 12-week intervention, these women will exhibit enhancements in both the muscular activation and contractile capacity of their pelvic floor, leading to a reduction in instances of urine leakage.

Study Overview

• Status: Completed
• Conditions: Strength; Muscle Activation; Urinary Incontinence (UI)
• Intervention / Treatment: Other: Pelvic floor muscle training intervention

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Universidad Politécnica de Madrid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Nulliparous FFT female athletes
• had been practicing FFT or weightlifting for at least 2 years
• train a minimum of 3 days/week
• had not previously performed pelvic floor exercises
• had no medical contraindications or previous pelvic floor surgeries

Exclusion Criteria:

• Any criterion that does not meet the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PFM strength; This group carries out a 12-week training intervention based on Kegel exercises to improve strength and muscle activation	Other: Pelvic floor muscle training intervention; The training program consisted of 12 weeks of PFM exercises, 3 times per week, with each session lasting between 10 and 15 minutes. The program followed different stages through the weeks: (1) proprioception of pelvic floor muscles activation and integration with diaphragmatic breathing, (2) stabilization and strengthening of the pelvic floor musculature through progressive overloading, and (3) transference of these exercises to FFT practice. During the 12 weeks, short contractions (2") were combined with longer ones (5 to 10"), carrying out the progressive overload by increasing the number of contractions, the duration of the contraction, or by evolving the execution position towards more upright postures and sporting movements.
No Intervention: Control Group; This group is used as a control group. They keep training their sports discipline but don't join the 12-week PFM training protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength	Maximal, medium and minimal force generated of the pelvic floor muscles, measured with a vaginal dynamometer, which involves a pelvimeter probe with two arms that could be separated up to 25°, connected to the Phenix USB2 device (Pelvimètre Phenix, Vivaltis). The closed pelvimeter is inserted into the vagina with one arm positioned against the posterior side of the symphysis pubis. Once in place, to evaluate the contractile force of the PFM, the participant performes a pelvic floor contraction for 10 seconds against the arms of the probe fixed at 5º (an isometric contraction).	From the enrollment to the end of treatment at 12 weeks
muscle activation	Measured as tone or initial inertia index (III) using a vaginal dynamometer, which involves a pelvimeter probe with two arms that could be separated up to 25°, connected to the Phenix USB2 device (Pelvimètre Phenix, Vivaltis). The closed pelvimeter is inserted into the vagina with one arm positioned against the posterior side of the symphysis pubis. Once in place, the probe is opened by 5° to measure basal muscle activation (initial inertia index) and shock absorption, which assesses the pelvic floor ability to withstand stress.	From the enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary incontinence (UI)	Measured with the International Consultation on Incontinence Questionnaire-short form (ICIQ-SF), which evaluates the frequency, severity and impact on quality of life (QoL) of urinary incontinence in men and women (in the female athletes in this case). It encompasses 4 items (frequency or urinary incontinence, amount of leakage, overall impact of urinary incontinence and self-diagnostic item) with a scoring scale of 0-21 reflecting the degree of urinary incontinence as slight (1-5), moderate (6-12), severe (13-18) and very severe (19-21).	From the enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Universidad Politecnica de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2023
• Primary Completion (Actual): July 6, 2023
• Study Completion (Actual): September 10, 2023

Study Registration Dates

• First Submitted: September 23, 2024
• First Submitted That Met QC Criteria: September 29, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): October 2, 2024
• Last Update Submitted That Met QC Criteria: September 29, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: UPM20221125; 20221125 (Other Identifier: Universidad Politécnica de Madrid)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be analyzed anonymously

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No