Approach of Chronic Pelvic Pain with Top Flat Magnetic Stimulation

Materials and Methods Vulvar Functional Status Questionnaire (VQ) was used for the evaluation of patient's chronic pelvic pain and muscle hypertone improvements. The interstitial cystitis was assessed by the Leary–Sant symptom and problem indexes (ICSI and ICPI). In this study, the scores resulting from the sum of the two indexes were evaluated as OSS (ICSI + ICPI). Results Women with chronic pelvic pain and muscle hypertone showed VQ mean values significantly lower than the controls (p  <  0.005) from the second treatment up to the sixth one. In 6 patients affected by interstitial cystitis, the mean score of OSS was significantly lower than the controls (p  <  0.005) from the second treatment up to 2 months follow-up after the last treatment session. No side effects were observed. Conclusion Based on these results, this technology may successfully manage muscle hypertonicity condition, the chronic pelvic pain, and interstitial cystitis.


Introduction
Pelvic foor tension myalgia (PFTM) is a type of pelvic foor dysfunction related to increased activity or hypertonicity of pelvic foor muscles that leads to chronic pelvic pain or miofascial syndrome [1].It is uncomfortable and potentially harmful to have tight, constantly contracted pelvic foor muscles.Women experience this condition much more frequently than male patients in their fourth to sixth decade of life [2,3].Te study of Mathias et al. [4] of more than 5,000 women aged 18 to 50 found that 14.7% of them had chronic pelvic pain that lasted for more than six months.It is important to keep in mind that pelvic pain syndromes are the root cause of sexual dysfunction.Early referral for sexual counseling during treatment is frequently benefcial for couples [5].
Te exact cause of pelvic foor tension myalgia is not known, but multiple variables may contribute to its development, such as nerve damage, irritable bowel syndrome, endometriosis, genitourinary infammation, interstitial cystitis, poor posture, aging, obesity, history of sexual abuse, pudendal nerve entrapment, trauma, reaction to pelvic organ disease, postsurgical scarring, rectal disorders, central pain sensitization, and psychological factors.Pelvic foor muscle spasm is thought to be a major cause of PFTM.Recurrent urinary tract infections (rUTIs), in particular interstitial cystitis symptoms without infection, are common in women and frequently present in general practice [6,7].
Interstitial cystitis, also known as painful bladder syndrome, can cause lower abdominal pain/discomfort, dyspareunia, and pain in any lower spinal nerve distribution.Additional bladder-related symptoms, such as frequency, urgency, or nocturia, are experienced by patients with this condition.It can afect people of all ages and should be considered for people who have other chronic pain conditions such as fbromyalgia, irritable bowel syndrome, chronic fatigue, or chronic pelvic pain [8].
Interstitial cystitis/painful bladder syndrome is frequently associated with high-tone pelvic foor dysfunction.Because of their syndromic nature and amorphous defnitions, these conditions are common in gynaecological patients presenting with chronic pelvic pain and are frequently misdiagnosed.Clinicians should be cautious of these processes in patients who sufer from recurrent urinary tract infection symptoms or chronic pelvic pain [9].Te two common tests used to diagnose interstitial cystitis are urinalysis/urine culture and cystoscopy, as reported by the National Institute of Diabetes and Digestive and Kidney Diseases.
Generally, a gynaecologist with great expertise follows a therapeutic path aimed at reducing the three triggering causes of pelvic chronic pain condition: reduction of local infammation as not to further fuel the disease, regularization of nerve transmission to decrease pain, and relaxation of contracted muscles (to improve the condition of the vulvar tissue, reduce friction during sexual intercourse and abrasions on the mucous membranes, and the consequent postcoital infections and irritation).
Treatment for PFTM is frequently difcult, with numerous treatments showing limited success.Te literature on PFTM treatment is quite varied.Massage, medication, high-voltage electro-galvanic stimulation (HVGS), biofeedback, short-wave diathermy, botulin toxin injections, relaxation therapies, cognitive behavioral therapy, ultrasound, sit baths, posture training, hydrotherapy, strengthening exercises, and transcutaneous electrical nerve stimulation (TENS) units appear to be most benefcial in these patients.Te outcomes of these treatments varied, and there is not much evidence to support or refute their efcacy [10].Analgesics and muscle relaxants are often employed to treat pelvic foor tension myalgia.Analgesics may reduce pain, but they do not address the underlying abnormality.Diazepam has been widely used, but only temporary improvement is obtained.Unfortunately, there are women who do not respond to conservative therapies represented by medical/pharmacological management, physical therapy techniques (electromyography (EMG) biofeedback, manual therapy, or electrotherapy), and surgery [11,12].In addition, patients are naturally reluctant to consider invasive surgical treatment [13].Even localized TENS [14,15] (therapy applied generally for genital syndrome and vulvar pain) does not appear to be efective for chronic pelvic pain treatment, as the vaginal musculature is too contracted to ft a probe and pain can be exacerbated.
Magnetic stimulation has been explored as an alternative to electrical stimulation recently for urological diseases, clinical neuro-diagnostic applications, and pelvic foor muscle strengthening, pain, and hypertonia to provide safe and noninvasive treatment for chronic pelvic pain syndrome [16][17][18].
Recently, Biondo and Colleagues [19] observed that patients reported signifcant improvement of vulvar pain as a result of PISQ-12's domain changes following top fat magnetic stimulation technology.
Based on these considerations, our study provided insight into the assessment of the efectiveness and safety of a novel device that uses top fat magnetic stimulation to treat women with interstitial cystitis and chronic pelvic pain.

Patient Population.
A total of 12 Caucasian women with a mean age of 30.66 (±14.66) were enrolled for this study (see Table 1).
To perform a correct and accurate diagnosis of chronic pelvic pain, we have excluded all the pathologies which could be responsible for the same type of painful symptoms; exclusion criteria included the presence of patients with menopause state, pelvic organ prolapses, genital infections, menstruation, malignant tumors, severe neurological diseases, pregnancy, obesity, and persons with pacemakers or metal implants.Inclusion criteria included patients afected by chronic pelvic pain and pelvic foor hypertonicity.
Te diagnosis of hypertonic pelvic foor is performed in all patients by an experienced gynaecologist with a manual assessment of the pelvic foor muscles and a swab test.
Tis study was conducted in accordance with the Good Practice Guideline and the Declaration of Helsinki and informed consent was obtained from all patients.

Study Device.
A noninvasive electromagnetic therapeutic device (DR ARNOLD, DEKA M.E.L.A. Calenzano, Italy) with a main unit and a chair applicator was used during the procedures.Te coil of the chair applicator, which is located in the center of the seat, is intended for therapy of the deep pelvic foor area.Te patient is seated on the chair with their perineum on the center of the seat, which helps them feel the stimulation of their pelvic foor and sphincter muscles during stimulation therapy.In order to stimulate the pelvic area, DR.ARNOLD can produce an electromagnetic feld with a homogenous profle (TOP FMS-TOP Flat Magnetic Stimulation).Gynaecologists initially set and adjusted the patient's position before each session to ensure an appropriate level of stimulation and achieve a uniform distribution of muscle involvement.Te benefcial efect of the subject device is due to a greater uniformity of magnetic feld distribution over a larger area, which allows for greater recruitment of muscle fbers without generating areas that difer in stimulation intensity.Te device's change in magnetic felds transmits the 2 Advances in Urology current into nerves which send signals to the muscles in order to contract and release them.Te crucial thing is the positioning of the patient (patient's pelvic foor muscle (PFM)) in the chair.Patients PFM should be positioned in the center of the magnetic feld for optimal (maximal) efect.First and foremost, the patient's comfort throughout the lengthy treatment session is ensured.Second, it makes it possible to center the electromagnetic feld on the patient's perineum.With the study device, the patient can be positioned precisely so that his legs are in the right positions by adjusting the seat height prior the treatment.Te legs of the patient are positioned perpendicularly, ensuring the thighs are parallel to the foor with the feet fat on the ground.At the knee, patients ought to create an angle of 90 degrees or slightly higher.Te subject system is equipped with protocols for reducing hypertonicity that use lowfrequency stimulations (around 10 Hz) in accordance with the treatment's goals.

Study
Protocols.Te DR ARNOLD system was applied for a total of 6 treatments on all patients.Sessions were conducted twice weekly for three consecutive weeks; depending on the patient's muscular condition, each session lasted 28 minutes.Te overtone/pain protocol (muscle work aimed at muscle inhibition and reduction of pain (hyperactivity and hypertone)) was selected after the frst two minutes of warm-up for all patients.Data were collected at baseline, after each treatment session up to 6 treatments, and after 2 months of follow-up after the last treatment session.In all patients, chronic pelvic pain was evaluated using the Vulvar Functional Status Questionnaire (VQ) [20].
Te interstitial cystitis was assessed by the Leary-Sant symptom and problem indexes (ICSI and ICPI).In this study, the scores resulting from the sum of the two indexes were evaluated as OSS (ICSI + ICPI) [21,22].
Possible side efects and adverse events such as muscular pain, temporary muscle spasm, temporary joint/tendon pain, or local erythema/skin redness were evaluated during all treatment periods.SPSS (IBM Corp., New York, USA) was used for all statistical analyses.Descriptive statistical analysis (means and ±SDs) was performed using the Student's t-test.A p < 0.05 is considered to be signifcant.

Results
Women with chronic pelvic pain alone or in association with muscle hypertonicity showed VQ mean values signifcantly lower than the controls (p < 0.005) from the second treatment up to the last one.For all patients evaluated, the mean score of Vulvar Functional Status Questionnaire (VQ) decreased from 13.7 (±4.47) at baseline to 12.5 (±5.25) after 1 treatment session, signifcantly decreased from 13.7 (±4.47) at baseline to 8.5 (±4.74) after 2 treatment sessions, to 6.3 (±4.24) after 3 treatment sessions, to 4.3 (±3.56) after 4 treatment sessions, and to 3.1 (±3.67) after 5 treatment sessions and to 2.86 (±4.49) after 6 treatment sessions, showing an improvement in chronic pelvic pain and in the four patients with hypertonicity symptoms (Figure 1).Te VQ mean score increases at 2 months after the last treatment compared to the score revealed at the sixth treatment but remains below the baseline value.Te nonsignifcance of the reduction of the VQ score at two months of follow-up compared to the baseline can be explained by the fact that a small number of patients were considered (5/12 patients).

Discussion
Te pelvic foor muscles are deeply stimulated by magnetic stimulation technology, which restores neuromuscular control [23].Muscle contraction or relaxation, neuronal cell depolarization, and efects on the blood circulation system are all outcomes of the interaction with the tissue.Te scientifc literature [24][25][26][27][28][29][30][31][32][33][34][35][36] states that this technology can afect sexuality and health in a broad patient population and safely and effectively treat stress, urge, and mixed urinary incontinence by strengthening the pelvic foor muscles.Te severity of UI symptoms was less severe, and the subjects used absorbent pads less frequently, both of which improved their quality of life.Patients also reported additional therapeutic efects, such as Advances in Urology 3  Advances in Urology improved urination control and increased sexual satisfaction, based on the subjective evaluation.Nevertheless, since the subject device can also select a specifc protocol for hypertonicity, the great advantage is the ability to treat pathologies such as chronic pelvic pain and muscle hypertonicity thanks to its decontracting action.Indeed, the overtone/pain protocol for hypertonic management may employ lower frequencies (around 10 Hz) to generate a homogenous electromagnetic feld distribution that does not create regions of diferent stimulation intensity, avoiding overstimulation of the already hypersensitive receptors and sensory nerves typical of chronic pelvic pain.Our fndings showed an improvement in the patient's chronic pelvic pain (such as dyspareunia, pain during intercourse, and vestibulitis) and muscle hypertone symptoms as assessed by VQ, without fnding any side efects.Te VQ is a valid questionnaire with sufcient internal consistency, testretest reliability, and validity to be useful for women's health physical therapists [20].
Women with chronic pelvic pain alone or in association with muscle hypertonicity showed VQ mean values signifcantly lower than the controls (p < 0.005) from the second treatment up to the last one.
We have observed that the VQ mean score increases slightly two months after the last treatment when compared to the score revealed at the sixth treatment, but it remains lower than the baseline value.Te nonsignifcance of the reduction of the VQ score at two months of follow-up compared to the baseline can be explained by the fact that a small number of patients were considered (5/12 patients).However, there are already published studies [32] in which an increase in the scores of the questionnaires used for the evaluation of urinary incontinence is observed with longer follow-ups.
In addition, interstitial cystitis was also treated with success as assessed by OSS questionnaire which reported promising results.In addition, when compared to the assortment of devices available for pelvic foor restoration, the subject device ofers additional signifcant benefts.It is a noninvasive device frst and foremost because no probe is inserted into the vaginal channel during muscle stimulation.As a result, patients can remain fully clothed in a supportive and ergonomic chair and resume their daily activities right away after sessions thanks to the consistent emission of energy that is gradually delivered.Finally, the DR.ARNOLD system can be viewed as an "educator" system, since it allows the patient to feel the relaxation of the muscles that are being treated, giving them more autonomy and awareness to decide when to repeat the next treatment session.
In addition, this technology can be utilized in conjunction with other pharmacological or physical techniques [30].Our long-term goal is to enroll more patients applying longer follow-up, in order to further investigate this innovative and noninvasive method of treatment for complicated pathologies such as muscle hypertonicity, chronic pelvic pain, and interstitial cystitis.

Conclusions
Our investigation reveals that this technology could represent a promising approach for the treatment of chronic pelvic pain as well as muscle hypertonicity condition and interstitial cystitis.Based on 2-month follow-up data, it seems that the efect is short-lasting, but a limited number of patients were evaluated at this time.In order to monitor the device's long-term efects, additional studies with follow-ups of up to 4 or 6 months will be required.

Figure 1 :Figure 2 :
Figure 1: Vulvar Functional Status Questionnaire (VQ) mean scores at baseline, after each treatment session up to 6 treatments, and after 2 months of follow-up after the last treatment session.

4. 1 .
Study Limitation.Study limitations are represented by a small patients' sample, a short follow-up, and the lack of a control group.