An interventional study of Pelvic floor muscle training intervention in Strength, Muscle Activation and Urinary Incontinence (UI), sponsored by Universidad Politecnica de Madrid. Completed at 1 site in Spain. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Universidad Politecnica de Madrid · Not applicable, Interventional, and Prevention
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.
1,375 studies on the registry are indexed under Urinary Incontinence; 224 are open to participants now.
This study's enrollment of 21 is below the median of 66 across 1,021 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Universidad Politecnica de Madrid is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
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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
This group is used as a control group. They keep training their sports discipline but don't join the 12-week PFM training protocol.
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.
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).
Time frame: 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.
Time frame: From the enrollment to the end of treatment at 12 weeks
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).
Time frame: From the enrollment to the end of treatment at 12 weeks
Plan to share: No — Data will be analyzed anonymously
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in Jul 2023, 2 months.
Of 423 non-industry interventional studies with no phase under Urinary Incontinence, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 39. This study's 2 months is below that.
Counting every sponsor, half of 515 studies reached it within 16 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Universidad Politecnica de Madrid