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A Pilot Randomized Controlled Trial of Extracorporeal Vaginal Peflex Weights for Enhancing Pelvic Floor Function and
Avital Bar Chen1,2, Tal Fligelman2, Leonid Kalichman1
1Department of Physical Therapy, Recanati School for Community Health Professions, Faculty of Health Sciences, Ben Gurion University of the Negev, P.O. Box 653, Beer-Sheva 8410501, Israel.
Background:
Stress 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.
Aims:
To 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.
Methods:
A 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.
Results:
In 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 (p = 0.015 and p = 0.007, respectively), as well as in the proportional change in levator hiatus contraction (p = 0.022). There was no significant difference in the improvement in ICIQ-UI-SF and perineometer measurements between the groups (p > 0.05). Additionally, there was a trend of higher satisfaction with the treatment in the Peflex group (p = 0.054).
Conclusions:
Peflex 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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