Trial reportInternational journal of environmental research and public health2025
A Pilot Randomized Controlled Trial of Extracorporeal Vaginal Peflex Weights for Enhancing Pelvic Floor Function and Relieving Stress Urinary Incontinence.
Trial report in International journal of environmental research and public health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundStress urinary incontinence (SUI) is the involuntary loss of urine during increased abdominal pressure, affecting 46% of adult women, particularly those over 40. Pelvic floor muscle (PFM) training is the first-line treatment supported by numerous high-quality studies. However, the effectiveness of biofeedback devices, such as vaginal weight cones, remains controversial. Peflex weights are a new type of vaginal extracorporeal weights developed for PFM training.
aimsTo evaluate the effectiveness of PFM training with Peflex weights in reducing SUI symptoms, improving muscle power and endurance, and comparing its efficacy to standard PFM training without weights.
methodsA pilot randomized controlled trial was conducted involving 35 women aged 18 to 50 diagnosed with SUI. Participants were randomly assigned to either the Peflex group (PFM training with Peflex weights) or the control group (PFM training without weights). Both groups engaged in six weeks of home-based training. The primary outcome was assessed using the self-reported International Consultation on Incontinence Questionnaire-Short Form (ICIQ-UI-SF). Secondary outcomes included evaluations based on the PERFECT scheme, perineometer measurements, and levator hiatus diameters obtained via ultrasound.
resultsIn the intragroup analysis, the Peflex group significantly improved all outcome measurements. Compared to the control group, the Peflex group demonstrated significantly higher improvement in muscle power and repetition of muscle contraction (
conclusionsPeflex weights effectively reduce SUI symptoms and improve muscle power and endurance, with high user satisfaction. However, there was no significant difference in the main outcome measure (ICIQ-UI-SF) between the Peflex and control groups. Further research is needed to identify which patients benefit most from this treatment.
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