Is It Possible to Improve Urinary Incontinence and Quality of Life in Female Patients? A Clinical Evaluation of the Efficacy of Top Flat Magnetic Stimulation Technology

Lopopolo, Graziella; Salsi, Benedetta; Banfi, Alessandra; González-Isaza, Pablo; Fusco, Irene

doi:10.3390/bioengineering9040140

Cited by 12 publications

(14 citation statements)

References 30 publications

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“…In the case of pelvic floor muscle hypertonic dysfunction, many non-invasive techniques are available. Physiotherapy is the first-line conservative therapy but has the disadvantage of having slow progression and low patient adherence and compliance with treatment [ 49 , 50 ]. The same thing can be said for Kegel exercises, whose effectiveness is reduced because they are often performed inconsistently or incorrectly over time by patients.…”

Section: Discussionmentioning

confidence: 99%

Changes in Pelvic Floor Ultrasonographic Features after Flat Magnetic Stimulation in Women with Chronic Pelvic Pain and Levator Ani Muscle Hypertonicity

Barba,

Cola,

De Vicari

et al. 2024

Medicina

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Background and Objectives: Chronic pelvic pain (CPP) represents a major public health problem for women with a significant impact on their quality of life. In many cases of CPP, due to gynecological causes—such as endometriosis and vulvodynia—improper pelvic floor muscle relaxation can be identified. Treatment of CPP with pelvic floor hypertonicity (PFH) usually involves a multimodal approach. Traditional magnetic stimulation has been proposed as medical technology to manage muscle hypertonicity and pelvic pain conditions through nerve stimulation, neuromodulation, and muscle relaxation. New Flat Magnetic Stimulation (FMS)—which involves homogeneous rather than curved electromagnetic fields—has the potential to induce sacral S2–S4 roots neuromodulation, muscle decontraction, and blood circulation improvement. However, the benefits of this new technology on chronic pelvic pain symptoms and biometrical muscular parameters are poorly known. In this study, we want to evaluate the modification of the sonographic aspect of the levator ani muscle before and after treatment with Flat Magnetic Stimulation in women with chronic pelvic pain and levator ani hypertonicity, along with symptoms evolution. Materials and Methods: A prospective observational study was carried out in a tertiary-level Urogynaecology department and included women with CPP and PFH. Approval from the local Ethics Committee was obtained before the start of the study (protocol code: MAGCHAIR). At the baseline, the intensity of pelvic pain was measured using a 10 cm visual analog scale (VAS), and patients were asked to evaluate their pelvic floor symptoms severity by answering the question, “How much do your pelvic floor symptoms bother you?” on a 5-answer Likert scale. Transperineal ultrasound (TPU) was performed to assess anorectal angle (ARA) and levator ani muscle minimal plane distance (LAMD). Treatment involved Flat Magnetic Stimulation alone or with concomitant local or systemic pharmacological therapy, depending on the patient’s preferences. FMS was delivered with the DR ARNOLD system (DEKA M.E.L.A. Calenzano, Italy). After the treatment, patients were asked again to score the intensity of pelvic pain using the 10 cm visual analog scale (VAS) and to evaluate the severity of their pelvic floor symptoms on the 5-answer Likert scale. Patients underwent TPU to assess anorectal angle (ARA) and levator ani muscle minimal plane distance (LAMD). Results: In total, 11 patients completed baseline evaluation, treatment, and postoperative evaluation in the period of interest. All patients underwent eight sessions of Flat Magnetic Stimulation according to the protocol. Adjuvant pharmacological treatment was used in five (45.5%) patients. Specifically, we observed a significant increase in both ARA and LAMD comparing baseline and post-treatment measurements (p < 0.001). Quality of life scale scores at baseline and after treatment demonstrated a significant improvement in both tools (p < 0.0001). Conclusions: Flat Magnetic Stimulation, with or without adjuvant pharmacological treatment, demonstrated safety and efficacy in reducing pelvic floor hypertonicity, resulting in improvement in symptoms’ severity and sonographic parameters of muscular spasm.

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Section: Discussionmentioning

confidence: 99%

Changes in Pelvic Floor Ultrasonographic Features after Flat Magnetic Stimulation in Women with Chronic Pelvic Pain and Levator Ani Muscle Hypertonicity

Barba,

Cola,

De Vicari

et al. 2024

Medicina

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“…For example, Lopopolo et al reported a significant improvement in quality of life and patients awareness of the pelvic floor area in 50 women with mixed urinary incontinence treated with six sessions of FMS even at the end of the treatment and at three months follow-up. In addition, at the baseline evaluation, patients most frequently experienced leakage several times a day, whereas after six sessions, the leakage occurred only about once a week or less [ 44 ]. Biondo et al evaluated the effectiveness and safety of flat magnetic stimulation in eighty-one female patients (35 patients who reported SUI symptoms and 46 patients who reported UUI symptoms) after eight 28 min treatment sessions (twice a week for 4 weeks).…”

Section: Discussionmentioning

confidence: 99%

Flat Magnetic Stimulation for Stress Urinary Incontinence: A Prospective Comparison Study

et al. 2023

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Background: Flat Magnetic Stimulation (FMS) is characterized by a stimulation generated by electromagnetic fields with a homogenous profile. One possible application is the treatment of stress urinary incontinence (SUI). We aimed to compare the objective, subjective, quality of life, and instrumental outcomes in women with SUI not eligible for surgery undergoing either FMS or pelvic floor muscle training (PFMT). Methods: This was a prospective interventional study. After proper counseling, patients with isolated SUI were divided according to their treatment of choice into FMS and PFMT groups. At baseline and after treatment, patients completed the International Consultation on Incontinence Questionnaire-Short Form, the Female Sexual Function Index, and the Incontinence Impact Questionnaire, and volumetric measurement of the urethral rhabdosphincter (RS) was performed. The Patient Global Impression of Improvement questionnaire and stress test defined subjective and objective cure rates, respectively. Results: We observed improvements in urinary-related quality of life scores and an increase in RS volume after FMS compared to baseline. All these outcomes were significantly better compared to women who underwent PFMT. Conclusion: Our study demonstrated that FMS is a safe and effective conservative option for SUI management in terms of objective and subjective cure rates.

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“…The questionnaires were completed right before every treatment, within the treatment period (until the 8th session). To assess SUI, the Urinary Incontinence Short Form (ICIQ-UI-SF), [ 6 , 22 ] was used to assess the severity of urinary leakage, the clinical manifestations of urinary incontinence, and the impact on quality of life. Moreover, the seven-question Incontinence Impact Questionnaire-Short Form (IIQ-7) [ 23 ] was helpful to evaluate the negative impacts of urinary incontinence on health-related quality of life in terms of physical activities, recreation, domestic tasks, social activities, travelling, emotional health and the sensation of frustration [ 24 ].…”

Section: Methodsmentioning

confidence: 99%

“…The prevalence ranges from 17% in women in their 20s to 38% in their 60s [ 4 ]; however, only 25% of patients seek specific medical treatment [ 5 ]. For this reason, in the last decade, many strategies have been investigated for treating UI [ 6 , 7 ]. They are surgical procedures, physical/conservative therapies (pessaries or vaginal cones, timing urination and restricting fluid intake), pharmacological approaches (anticholinergic drugs, urethral bulking agents, vaginal oestrogens and peripheral nerve stimulation), and behavioural therapies (Kegel exercises, vaginal weight training, biofeedback and electrical stimulation of pelvic floor) [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

“…They are relevant alternatives that have the benefit of allowing people to stay comfortably clothed during a treatment. Recently published studies have proven that TOP Flat Magnetic Stimulation (TOP FMS) technology reduced urge, mixed, and stress incontinence issues, yielding positive effects and enhancing patients’ quality of life (QOL) without risk [ 6 , 14 ]. Indeed, FMS technology, with a homogenous profile and creating no areas of uneven stimulation intensity, enables the strengthening of muscle mass through neuromuscular stimulation because it depolarizes motor neurons, causing large and deep muscle contractions.…”

Section: Introductionmentioning

confidence: 99%

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A Qualitative and Quantitative Study to Evaluate the Effectiveness and Safety of Magnetic Stimulation in Women with Urinary Incontinence Symptoms and Pelvic Floor Disorders

Filippini,

Biordi,

Curcio

et al. 2023

Medicina

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Background and objectives: Involuntary loss of urine owed to dysfunction of the detrusor muscle or muscles of the pelvic floor is known as urinary incontinence (UI). In this study, ultrasound monitoring was employed for the first time to measure the usefulness and safety of electromagnetic stimulation for women with Stress or Urge UI. Materials and Methods: A total of 62 women were enrolled, with a mean age of 55.1 (± 14.5); 60% of them were menopausal and presented with urinary incontinence (UI). Eight validated questionnaires were used to evaluate Stress UI, prolapse, overactive bladder urge, faecal incontinence, and quality of life, and the whole study population was tested with ultrasounds at the beginning and at the end of the treatment cycle. The device used was a non-invasive electromagnetic therapeutic system composed of a main unit and an adjustable chair applicator shaped for deep pelvic floor area stimulation. Results: Ultrasound measurements and validated questionnaires revealed a consistent and statistically significant (p < 0.01) improvement of the mean scores when pre- and post-treatment data were considered. Conclusions: Study results showed that the proposed treatment strategy led to a significant improvement in Pelvic Floor Muscle (PFM) tone and strength in patients with UI and pelvic floor disorders, without discomfort or side effects. The demonstration was qualitatively carried out with validated questionnaires and quantitatively with ultrasounds exams. Thus, the “chair” device we used represents valuable and effective support that could be widely employed in the gynaecological field for patients affected by different pathologies.

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Is It Possible to Improve Urinary Incontinence and Quality of Life in Female Patients? A Clinical Evaluation of the Efficacy of Top Flat Magnetic Stimulation Technology

Cited by 12 publications

References 30 publications

Changes in Pelvic Floor Ultrasonographic Features after Flat Magnetic Stimulation in Women with Chronic Pelvic Pain and Levator Ani Muscle Hypertonicity

Changes in Pelvic Floor Ultrasonographic Features after Flat Magnetic Stimulation in Women with Chronic Pelvic Pain and Levator Ani Muscle Hypertonicity

Flat Magnetic Stimulation for Stress Urinary Incontinence: A Prospective Comparison Study

A Qualitative and Quantitative Study to Evaluate the Effectiveness and Safety of Magnetic Stimulation in Women with Urinary Incontinence Symptoms and Pelvic Floor Disorders

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