Hypothesis / aims of study
Pelvic floor disorders (PFDs) are very widespread and are known to affect millions of women worldwide, significantly impairing quality of life. New technologies and innovations such as electrotherapy, photobiostimulation, radiofrequency, and electroporation are currently revolutionizing conservative treatment, allowing personalization of treatments.
The aim of this study was to evaluate the feasibility and initial results of tailored treatment using these new technologies for PFDs treatment
Study design, materials and methods
This was a prospective study (IRB code: GSM-RF 2025) aimed to analyze the impact of the innovative EVA / DAFNE System to treat PFDs through customized treatments. Patients who desired a conservative treatment through energy based devices for their PFDs - including pelvic organ prolapse, stress, urge, and mixed urinary incontinence, bladder voiding dysfunction function and muscle hypertonicity related pelvic pain - were enrolled.
Baseline and after treatment quality of life were assessed through the following validated scales: Urinary Distress Inventory-6 (UDI-6), Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6), Female Sexual Function Index-6 (FSFI-6), Marinoff Scale, 0-100 VAS Scale, Vaginal Health Index. Moreover, overall improvement was measured through the Patient Global Impression of Improvement (PGI-I).
Electrotherapy was delivered through 4 gold rings, providing Functional Electrical Stimulation (FES), Transcutaneous Electrical Nerve Stimulation (TENS) and/or Microcurrent Electrical Neuromuscular Stimulator (MENS). The photobiostimulation system consisted of 24 LEDs per wavelength (420nm UVA; 630nm RED; 870nm NIR/INFRARED) positioned at 360° along the entire length of the handpiece for antimicrobial purpose, microcirculation improvement, and anti-inflammatory action. The radiofrequency device employed Dynamic Quadripolar Radiofrequency Technology (DQRF), a proprietary hardware and software system that dynamically configures the emission electrodes as transmitters and receivers based on the selected program to ensure precise energy delivery by continuously adjusting the electrode configuration during treatment. Electroporation was delivered through Ultrapulsed Radioporation technology (UPR), an advanced electroporation method that uses a radiofrequency-generated electric field to enhance cell membrane permeability and open aqueous channels, to facilitate radioporation, allowing the delivery of active ingredients (Figure 1). Three to Five sessions of the given treatment were delivered according to necessity. Statistical analysis was performed using Student T-Test. A p<0.05 was considered as significant.
Results
In the period of interest 26 were treated with the System. Mean age was 48.6±16.7 years. Indications for treatment were dyspareunia (38.5%), stress urinary incontinence (34.6%), mild pelvic organ prolapse (23.1%), genitourinary syndrome of menopause (19.2%), voiding dysfunction (15.4%), and overactive bladder syndrome (7.7%). Treatments and technologies were tailored according to each patients’ symptoms and clinical findings, making the most from the System possibility in terms of customization. Mean number of treatments per patient was 4. Baseline and after treatment quality of life scores are reported in Table 1. According to PGI-I scores 88.5% of patients considered themselves improved.
Interpretation of results
EVA / DAFNE System was successful in managing a variety of PFDs improving quality of life scores.