Stesura Seveso Archivio Italiano di Urologia e Andrologia 2024; 96(3):12623 1 ORIGINAL PAPER a separate condition, defining chronic primary pain as any pain without a clear cause (2). An estimated 4% to 16% of women worldwide (3, 4) are thought to experi- ence chronic pelvic pain in their lives, which is also known as persistent noncancer pelvic discomfort. This condition frequently results in discomfort during sex (dyspareunia), orgasmic dysfunction, and decreased desire, arousal, and lubrication in addition to producing pain in or perceived to be in the pelvic tissues (5). Pelvic discomfort and symptoms of the lower urinary tract are the two main clinical hallmarks of chronic pelvic pain syn- drome (CPPS). Different aspects of the CPP have been investigated through the years. According to scientific research in the literature, compared to women without chronic pelvic pain, women with chronic pelvic pain exhibited increased pelvic floor muscular tone, stronger resistance to pressure application, and slower stretching of the pelvic floor muscles by the index finger (6, 7). Additionally, they demonstrated lower pelvic floor mus- cular flexibility and increased pelvic floor muscle stiff- ness. Finally, electromyography (EMG) analysis revealed that the women with persistent pelvic discomfort had increased myoelectrical activity in both the superficial and deep pelvic floor muscles (6, 8). Although there are many theories on the aetiology of myofascial pain, none of them have been proven in the literature. According to one idea, metabolic alterations at the level of the motor endplate that result in muscular hyperactivity or micro- scopic muscle injury are the source of myofascial pain (9, 10). Additionally, it has been postulated that myofascial pain involves alterations in the central nervous system, such as glial cell proliferation and neuronal cell death, which could account for the referred pain patterns observed in myofascial pain pathologies (9, 11). Finally, it has been proposed that the persistent muscle spasm and contraction associated with myofascial pain represents a compensating strategy for pelvic floor dysfunction or defects in the design of the levator ani muscle (9, 10). Background: The increased hypertonicity or activity of pelvic floor muscles can lead to chronic pelvic pain (CPP). It represents an aspecific and persist- ent pain with no apparent clinical reason, affecting an estimated 6% to 16% of women worldwide. This study aimed to evaluate with validated questionnaires the efficacy and the safeness of a new device that uses Top flat Magnetic Stimulation for the man- agement of muscular hypertonia in women with CCP. Methods: All patients underwent 8 sessions of treatment with a non-invasive electromagnetic therapeutic device. The device pro- duces a TOP Flat Magnetic Stimulation with a uniform profile so, the muscle work aims to reduce pain while also inhibiting muscle activity. The PISQ-12 questionnaire was used for the evaluation of improvements. Side effects were monitored. Results: The PISQ-12 total mean score decreases from 29.2 (± 3.3) to 17 (± 2). Regarding the behavioural-emotive items (1-4), a decrease from 12 (± 2) to 7 (± 0.9) was observed. Physical items (5-9) decrease from 10.6 (± 1.8) to 6 (± 1.4) and the Partner Related items (10-12) from 6.6 (± 1.6) to 3.9 (± 0.4). Conclusions: The device we used in this research demonstrated to be a valid tool for the treatment of chronic pelvic pain in female patients. KEY WORDS: Electromagnetic stimulation; Pelvic floor hypertonia; Chronic pelvic pain; Women. Submitted 30 April 2024; Accepted 5 May 2024 INTRODUCTION The increased hypertonicity or activity of pelvic floor muscles can lead to chronic pelvic pain (CPP) or myofascial syndrome when the type of pelvic floor dysfunction called Pelvic floor tension myalgia (PFTM) occurs (1). CPP management is a tremendous concern for healthcare pro- fessionals and a significant financial burden for healthcare systems because it represents an aspecific and persistent pain with no apparent clinical reason. The World Health Organisation (WHO) has lately recognised chronic pain as Electromagnetic stimulation to reduce the hypertonia of the pelvic floor muscles and improve chronic pelvic pain in women Nicola Mondaini 1, Mauro Gacci 2, Tommaso Cai 3, Francesco Lotti 4, Vincenzo Li Marzi 2, Fabio Crocerossa 1, Francesco Cantiello 1, Sara Tanguenza 5, Alessandra Comito 6, Irene Fusco 6, Beatrice Marina Pennati 6, Rocco Damiano 1 1 Department of Urology, Magna Graecia University of Catanzaro, Catanzaro, Italy; 2 Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Florence, Italy; 3 Department of Urology, Santa Chiara Regional Hospital, Trento, Italy; 4 Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy; 5 Pelvic Pain Centre, Florence, Italy; 6 El.En. Group, 50041 Calenzano, Italy. DOI: 10.4081/aiua.2024.12623 Summary Archivio Italiano di Urologia e Andrologia 2024; 96(3):12623 N. Mondaini, M. Gacci, T. Cai, et al. 2 Myofascial pain is the most common symptom in patients with CPP and it can be the primary source of pain, unrelat- ed to organ disease, or it can be a secondary source of pain elicited by a reflex response (visceral-muscle reflex) (3). Trigger points often develop in the affected muscles. Trigger points are specific areas of tenderness that develop in the muscle wall and can begin as just a symptom of pelvic pain, or they can be the main source of the pain. For this reason, treating trigger points can significantly reduce pain. In addition, it has been noted that it is a very common find- ing that the origin of the pain area was previously affected by gynaecological (ovarian cysts, endometriosis, dyspareu- nia, vulvodynia, recurrent candidiasis), or urological (inter- stitial cystitis/painful bladder syndrome, urgency/frequen- cy, urge incontinence), or colorectal (constipation, proctal- gia fugax, irritable bowel syndrome), or tissue adherence (scarring following surgery) disorders, or other muscu- loskeletal or neural (pudendal neuralgia, coccygodynia, post-surgical or postnatal pelvic pain) conditions (12). However, there is currently no standardized and reliable technique for evaluating myofascial pain. An evidence- based physical examination for myofascial pain is required considering the mounting evidence linking myofascial pain to chronic pelvic pain syndromes and new information pointing to a connection between subclinical myofascial pain and lower urinary tract symptoms (LUTS). In addition, although some aspects of the pelvic floor myofascial evalu- ation may be the same in men and women, the method used to access these muscles differs, hence for the purpos- es of this research study, we chose to concentrate on exam- ination techniques in women (13, 14). There are numerous treatment methods for managing PFTM and CPP, including pharmaceutical (analgesics and muscle relaxants) and non-pharmacological therapies. Between these, there are high-voltage electro-galvanic stim- ulation (HVGS), transcutaneous electrical nerve stimulation (TENS) devices, ultrasound, short wave diathermy, mas- sages, posture training and strengthening exercises, biofeedback, botulin toxin injections, hydrotherapy, and sitz baths seem to be the most effective treatments. Nevertheless, some women do not react to conventional treatments such as medical/pharmacological manage- ment, physical therapy methods or surgery (15, 16). It is important to remember that all these levels of pain should be treated together with a multidisciplinary thera- py approach to be effective. The treatment can therefore include, in addition to the rehabilitation treatment with a midwife, also a psychological, and medical consultation and/or the use of supplements or drugs. It may happen that it is not possible to completely solve the pain. An effective treatment means that the pain has decreased to a level where you can once again enjoy your life and the activities you did before the pain began (17, 18). In this study, we explored the effectiveness of extracorpo- real Top flat Magnetic Stimulation (FMS) for improving chronic pelvic pain conditions. After its approval by the FDA in 1998, FMS is now mostly used for the treatment of Urge Urinary Incontinence (UUI). It is a viable option with the significant advantage of letting patients remain com- fortable in their clothes throughout a procedure. Depending on the protocol, the FMS technology allows the improvement of muscle mass by neuromuscular stimula- tion since it depolarizes motor neurons, inducing large and deep muscle contractions. On the other hand, it can help in the treatment of muscular hypertonia inducing fibres relaxation while maintaining a uniform profile and pre- venting any areas of irregular stimulation intensity (19). Moreover, because magnetic stimulation has no impact on cutaneous receptors, the discomfort associated with electrostimulation is also avoided. This study aimed to evaluate with validated question- naires the efficacy and the safeness of a new device that uses Top flat Magnetic Stimulation for the management of muscular hypertonia in women with CCP. MATERIALS AND METHODS A retrospective evaluation study was conducted at the Pelvic Pain Centre, Florence, Italy between January, and September 2023. Study population Patients presenting secondary chronic pelvic pain due to cystitis, endometriosis or vulvodynia, and non-responders to the current available pharmacological or physical solu- tions, were considered in this study. To make a precise diag- nosis of chronic pelvic pain, we have ruled out all other pathologies that might be causing the same kind of excruci- ating symptoms. These conditions included menopause, pelvic organ prolapses, genital infections, menstruation, malignant tumours, severe neurological diseases, pregnancy, obesity, and those who had metal implants or pacemakers. Patients with hypertonicity of the pelvic floor and persistent pelvic discomfort met the inclusion criteria. An experienced gynaecologist manually evaluated the pelvic floor muscles in all patients to diagnose hypertonic pelvic floor (19). Also, any previous gynaecological surgery was considered as an exclusion criterion for enrolment in the investigation. Lastly, patients were asked to avoid any other pharmacological (also painkillers) and non-pharmacological medications from 15 days before the study began and for the whole duration of the study. Other contraindications include the presence of cardiac pacemakers, implanted defibrillators/ Table 1. Baseline characteristics of the study participants (n = 40). No Characteristics Frequency (n) Proportion (%) 1 Age (mean ± SD) (years) 34.7 ± 8.1 18-30 12 30 31-50 28 60 2 Marital status Married 33 82.5 Single 7 17.5 3 Education level Primary 9 22,5 Higher education 31 77.5 4 Past medical/surgical history Yes 34 85 No 6 15 5 Family history of Pelvic Inflammatory Disease (PID) Yes 18 45 No 22 55 Archivio Italiano di Urologia e Andrologia 2024; 96(3):12623 3 Electromagnetic stimulation to reduce the hypertonia of the pelvic floor muscles and improve chronic pelvic pain in women neurostimulators, electronic or metal implants, bleeding conditions, cardiac diseases, pulmonary deficiency, malig- nant cancerous lesions, pregnancy, severe inflammatory conditions, fever and weight over 160 kilograms. Study device For this study, was used a non-invasive electromagnetic therapeutic device (DR ARNOLD, DEKA M.E.L.A. Calenzano, Italy) with a chair applicator and a main unit. The chair has a coil in the centre of the seat to target the deep pelvic floor area. Before each session, a gynaecolo- gist set the patient's position to guarantee the best result. The patient's legs are set up perpendicularly so that the thighs are parallel to the floor and the feet are flat. Patients should bend their knees to a 90-degree angle or slightly higher. This way, the perineum of the patient is perfectly aligned with the centre of the seat, and the local stimulation of the sphincter muscles and pelvic floor is at maximum. The device produces a TOP Flat Magnetic Stimulation electromagnetic field with a uniform profile. The magnetic fields transmit current directly to the mus- cle tissue in-, contracting or relaxing it. The electromag- netic stimulation's spatial profile (Figure 1) distinguishes DR ARNOLD from other devices. It covers a larger area, is uniformly dispersed. Because of this configuration, elec- tromagnetic radiation can be distributed deeply, symmet- rically, and uniformly, reaching deep neural areas inside the pelvis without dispersing superficially. Study protocols Procedure protocols for reducing hypertonicity with low- frequency stimulations (around 10 Hz), were used. A total of 8 treatment sessions for every patient were per- formed. Sessions were held twice weekly for 4 weeks in a row, lasting ca 30 minutes depending on the patient's muscle condition. After the first two minutes of warm-up for all patients, the Overtone/Pain protocol was chosen (19). The warm-up phase is a gentle muscle activation; it is a preparation step in which blood circulation is increased with low frequencies (about 5 Hz). Using fre- quencies of about 10 Hz, the overtone/pain protocol pro- duces low-level electric currents on neuromuscular tis- sue, which depolarizes neurons and causes decontraction of the pelvic floor muscles. So, the muscle work aims to reduce pain (hyperactivity and hypertonia) while also inhibiting muscle activity. Data were gathered at the beginning of the study, at the end of each treatment ses- sion, and three months later. Potential side effects and adverse events such as muscle soreness, momentary muscle spasms, joint/tendon pain, or local erythema/skin redness were monitored through- out the treatment period. Validated questionnaires CPP was assessed using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) (20). It is a test of sexual function and a condensed version of the PISQ-31 (21). The PISQ-12 has three domains: partner- related (items 10-12), physical (items 5-9), and behaviour- al-emotive (items 1-4). Lower scores imply enhanced sex- ual function. Scores are calculated by totalling the scores for each question, going from 0-never to 4-always. Reverse scoring is used for items 1, 2, 3 and 4 (20). It was admin- istered before the first treatment and right after the last ses- sion. Moreover, a Visual Analogue Scale (VAS) was used to col- lect information from every patient about the pain inten- sity perceived before and after the last treatment. The scores ranged from 0 (No Pain) to 10 (Very Painful, not bearable). Figure 1. Spatial profile of the uniform distribution of Flat Magnetic stimulation. Courtesy of DEKA M.E.L.A company. Archivio Italiano di Urologia e Andrologia 2024; 96(3):12623 N. Mondaini, M. Gacci, T. Cai, et al. 4 Statistical analysis The statistical analysis was performed with SPSS (IBM Corp., New York, USA). Specifically, the Student t-test (p < 0.05 for significance) was conducted (means and ± SDs). RESULTS In total, 40 women presenting secondary chronic pelvic pain were considered. Some general demographic informa- tion is reported in Table 1. The population median age was 34.7± 8.1 year (from the youngest, 19 years old, to the eld- est, 45 years old). The great majority of the subjects were married (82.5%) and with a higher education (77.5%). Moreover, most of them have had surgical events in the past. Generally, no side effects were observed during the study. When the results of the questionnaires are consid- ered, the PISQ-12 total mean score proved to be statisti- cally significant different (p < 0.05) and decreases from 29.2 (± 3.3) to 17 (± 2) at the end of the study. The same statistical significance is found when analysing the single items. Regarding the behavioural-emotive items (1-4), a decrease from 12 (± 2) to 7 (± 0.9) was observed. Physical items (5-9) decrease from 10.6 (± 1.8) to 6 (± 1.4) and the Partner Related items (10-12) from 6,6 (± 1.6) to 3.9 (± 0.4) (see Table 2 and Figure 2). The VAS questionnaire scores were collected by every patient at baseline (before the first treatment) and right after the last treatment. The mean score decreased from 8 (± 1.3) to 3 (± 0.6) with statistical significance (p < 0.05) (see Table 3 and Figure 3). Figure 2. Graphical representation of the PISQ-12 questionnaire: mean results divided by different items (behavioural–emotive (items 1-4), physical (items 5-9), and partner-related (items 10-12) at baseline (pre-first treatment) and after the last treatment. Figure 3. Graphical representation of the VAS questionnaire for the pain intensity evaluation. The mean results pre- and post-treatment are shown. Table 2. PISQ-12 questionnaire mean results divided by different items (behavioural-emotive (items 1-4), physical (items 5-9), and partner-related (items 10-12) pre- and post-treatments. PISQ-12 Questionnaire Baseline Post-treatments Significance Mean (± SD) Mean (± SD) Total score 29.2 (± 3.3) 17.0 (± 2.0) p < 0.05 Behavioural-emotive Items (1-4) 12.0 (± 2.0) 7.0 (± 0.9) p < 0.05 Physical Items (5-9) 10.6 (± 1.8) 6.0 (± 1.4) p < 0.05 Partner related items (10-12) 6.6 (± 1.6) 3.9 (± 0.4) p < 0.05 VAS Questionnaire Baseline Post-treatments Significance Mean (± SD) Mean (± SD) Score 8.0 (± 1.3) 3.0 (± 0.6) p < 0.05 Table 3. VAS questionnaire mean results at baseline (before the first treatment) and after the last treatment are reported. VAS Questionnaire Baseline Post-treatments Significance Mean (± SD) Mean (± SD) Score 8.0 (± 1.3) 3.0 (± 0.6) p < 0.05 Archivio Italiano di Urologia e Andrologia 2024; 96(3):12623 5 Electromagnetic stimulation to reduce the hypertonia of the pelvic floor muscles and improve chronic pelvic pain in women No correlation between the patient’s age and different PISQ- 12 item score results was remarkable (see Figure 4). Magnetic stimulation appears to be effective in the observed improvement of sexual function and health regardless of patient age as shown by the consistent reduction of the PISQ-12 questionnaire scores. DISCUSSION In women, when the pelvic floor muscles show an increased hypertonicity or activity, it can lead to CPP. The magnetic stimulation technique deeply interests the muscles of the pelvic floor, restoring neuromuscular control (22). The interaction with the tissue can result in muscle contraction or relaxation, depolarization of neuronal cells, and changes to the blood circulation system. According to the scientific literature (23-27), this technology may have an impact on the sexuality and health of a large patient population. Based on the subjective assessment, patients also reported addi- tional therapeutic advantages, such as improved urine con- trol (28-30) and higher sexual satisfaction (31). In fact, the overtone/pain protocol for hypertonic management may use lower frequencies (around 10 Hz) to produce an electro- magnetic field distribution that is homogeneous and does not produce regions of different stimulation intensity, pre- venting overstimulation of the already hypersensitive recep- tors and sensory nerves typical of chronic pelvic pain. Because no probe is placed into the vaginal channel during muscle stimulation, the device we employed is considered non-invasive. Thanks to the steady emission of energy that is progressively given, patients can continue to be fully clothed in a comfortable and supportive chair and resume their daily activities straight immediately following sessions. The DR ARNOLD system can also be seen as an "educator" system because it enables the patient to sense the relaxation of the treated muscles, allowing them more autonomy and awareness to choose when to repeat the next treatment ses- sion. Furthermore, the use of this novel technology can be combined with existing pharmacological or physical meth- ods (32). The etiopathology of CPP is not fully understood. Indeed, genito-pelvic pain/penetration disorders, vulvody- nia, interstitial cystitis/bladder pain syndrome and endometriosis, are just a few of the illnesses that can pro- duce CPP. However, it's possible that women with any of these diseases have identical pelvic floor muscle tone and functionality. Studying the correlation between personal and social characteristics such as the marital status or the education level and the presence of CPP, was not matter of this research study. But, according to other investigation in literature, pelvic floor muscle strength (PFMS) declines with age and ageing increases the likelihood of incontinence and genital organ prolapses and also CPP development (33, 34). Furthermore, a number of studies have demonstrated a strong correlation between pelvic floor diseases and educa- tional attainment [34-36). Similar findings were made by Gümüssoy et al. (2021) [37), where it was discovered that as women's educational levels rose, so did their PFMS values. This finding implies that women's awareness of PFMS is raised by education. According to the results of this study, women with lower income levels or without employment had lower PFMS values. Overholt et al. (2019) (38) described a clinical case pro- viding support to evaluate the efficacy of pulsed electro- magnetic field therapy for the management of chronic pelvic pain in interstitial cystitis/bladder pain syndrome. Indeed, for urinary incontinence higher frequencies (fre- Figure 4. Graphical representation of the correlation between the patient’s age and different PISQ-12 item score results. Archivio Italiano di Urologia e Andrologia 2024; 96(3):12623 N. Mondaini, M. Gacci, T. Cai, et al. 6 quencies ≥ 20 Hz) are needed to target the muscles and improve muscular tone. In this study, device protocols with a low-frequency (10Hz) emission were used. By using the Top FMS technology, the distribution of the magnetic vibrations is homogeneous in the treated area. Indeed, these low frequencies are able to create a homo- geneous distribution of the electromagnetic field that does not create regions of different stimulation intensity avoiding an overstimulation/overactivation of the pelvic floor muscles. In this way, no energy-peak can be pro- duced. This is important because, in patients presenting CCP, these energy-peaks can cause opposite outcomes, resulting in the worsening of the pain feeling due to an overactivation of the pelvic floor muscles. With this study we wanted to evaluate with validated ques- tionnaires the efficacy and the safeness of a new device that uses Top flat Magnetic Stimulation for the management of muscular hypertonia in women with CCP. Our results indi- cated that the patient's symptoms of muscular hypertonia and chronic pelvic pain were improved. As support, the PISQ-12 questionnaire was used because of its internal consistency, test-retest reliability, and validity. After the final therapy, we have seen a considerable decrease in the PISQ- 12 mean score. When the single items are considered, the trend is comparable. Also, results from the VAS question- naires revealed a statistically significant reduction of the patient pain perception after the conclusion of the treat- ment cycle. No correlation between the patient’s age and different PISQ-12 item score results was remarkable prob- ably indicating the wide efficacy of the magnetic stimula- tion regardless the age of the patient. Study limitations Our long-term objective is to register additional patients to further examine this novel, non-invasive approach to treating complex illnesses such as chronic pelvic pain without sex distinction. Moreover, the number of patients enrolled should be increased and a control group should be included for better completeness. Lastly, it would be interesting to evaluate the short-term and long-term improvement of the symptoms following the patients after the conclusion of the treatment cycle. CONCLUSIONS The device we used in this research demonstrated to be a valid tool for the treatment of chronic pelvic pain in female patients. Further studies are needed to have a deeper knowledge about the electromagnetic stimulation activity in reducing the hypertonia of the muscles since it could be the right strategy to improve the quality of life of the patients affected. REFERENCES 1. Grimes WR, Stratton M. Pelvic Floor Dysfunction’, in StatPearls, Treasure Island (FL): StatPearls Publishing, 2023. Accessed: Dec. 14, 2023. [Online]. Available: http://www.ncbi.nlm.nih.gov/books/ NBK559246/ 2. World Health Organization (WHO), ICD-11 for Mortality and Morbidity Statistics. 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Correspondence Nicola Mondaini, MD n.mondaini@unicz.it Fabio Crocerossa, MD crocerossa@unicz.it Francesco Cantiello, MD cantiello@unicz.it Rocco Damiano, MD damiano@unicz.it Department of Urology, Magna Graecia University of Catanzaro, Catanzaro, Italy Mauro Gacci, MD maurogacci@gmail.com Vincenzo Li Marzi, MD vlimarzi@hotmail.com Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, Florence, Italy Tommaso Cai, MD ktommy@libero.it Department of Urology, Santa Chiara Regional Hospital, Trento, Italy Francesco Lotti, MD francesco.lotti@unifi.it Sexual Medicine and Andrology Unit, Department of Experimental and Clinical Biomedical Sciences, University of Florence, Florence, Italy Sara Tanguenza, MD saratanguenza@gmail.com Pelvic Pain Centre, Florence, Italy Alessandra Comito, MD a.comito@elen.it Irene Fusco, MD (Corresponding Author) i.fusco@deka.it Beatrice Marina Pennati, MD b.pennati@deka.it El. En. Group, 50041 Calenzano, Italy Conflict of interest: BMP, IF and AC are employed at El. En. Group. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Institutional Review Board Statement: All the authors declare that the procedures followed were in accordance with the Declaration of Helsinki. Informed Consent Statement: Informed consent was obtained from all subjects involved in the study.