Research Studies

“Functional Magnetic Stimulation” (FMS) of the pelvic floor using the PelviPower magnetic field trainer is based on the principle of “Repetitive Peripheral Muscle Stimulation (RPMS)” and has proven to be an effective form of therapy that can be applied across a broad spectrum of the population.

You will find an overview of the available research results below, divided into specific areas of application. In each area you will find a written summary of the efficacy of FMS, with relevant citations. All cited studies are then listed below the summary and are available for you to download in PDF format.

No adverse effects or safety concerns were reported in any of the available peer-reviewed research studies or controlled trials on FMS, thus it is recognised that FMS is a safe and non-invasive treatment option.

Recent systematic reviews and meta-analyses comparing all published randomised controlled trials (RCTs) on ‘Functional Magnetic Stimulation’ (FMS) for urinary incontinence (UI) conclude that FMS is an effective treatment modality [1,2,3].


Urinary incontinence

The positive effect of FMS was reflected in the significant improvement in quality of life, cure rates and significantly improved objective and subjective measures of incontinence. For instance, FMS therapy alleviated urinary incontinence, evaluated with the internationally validated ICIQ-UI SF questionnaire, in both male and female patients with urge incontinence [4] or stress incontinence [5] who were refractory to conventional pelvic floor training. The studies varied from looking at continuous stimulation of 10 Hz [4] to frequencies of up to 50 Hz. FMS at a frequency of 50 Hz, administered for 20 minutes, twice weekly for two months, produced positive long-term response rates at one year in a female SUI population [6,7]. Responders were defined as a five-point reduction on the ICIQ-UI SF, with 70% in the FMS treatment group being responders compared with only 25% in the control group [6].

The efficacy of FMS has also been demonstrated by electromyography (EMG), urodynamic testing and diagnostic ultrasound [8,9,10,11]. For example, significant improvement in pelvic floor muscle EMG activity was found after a single FMS intervention (10 – 50 Hz) compared to a sham control group [8]. Shorter treatment programmes of six 20-minute sessions in a mixed population of men and women with UI also show improved long-term effects on incontinence, significant reductions in micturition frequency and nocturia, and improved urodynamic outcomes [9]. In addition, benefits from increased sexual desire were reported [12]. Silantyeva et al. (2019) used diagnostic ultrasound to demonstrate significant positive changes in pelvic floor dynamics: a reduction in urine leakage and pelvic floor impairment after treatment. A difference that was not observed in either the electrostimulation or sham control groups [11].].

References:
1. Meta-analysis of the Efficacy of Magnetic Stimulation for Female Stress Urinary Incontinence.
Sun K, Wu G, Wang J, Wang T, Zhang D, Cui Y, Wu J.
2020 July; doi: 10.22541/au.159526962.24960303.


2. Magnetic stimulation for female patients with stress urinary incontinence, a meta-analysis of studies with short-term follow-up.
Peng L, Zeng X, Shen H, Luo D.
2019 May; 98(19):e15572. doi: 10.1097/MD.0000000000015572.


3. An Effective Meta-analysis of Magnetic Stimulation Therapy for Urinary Incontinence
He Q, Xiao K, Peng L, Lai J, Li H, Luo D, Wang K.
Sci Rep. 2019 Jun; 9077. doi: 10.1038/s41598-019-45330-9

4. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence
Yamanishi T, Homma Y, Nishizawa O, Yasuda K, Yokoyama O; SMN-X Study Group.
Int J Urol. 2014 Apr;21(4):395-400. doi: 10.1111/iju.12289.

5. Effects of magnetic stimulation on urodynamic stress incontinence refractory to pelvic floor muscle training in a randomized sham-controlled study.
Yamanishi T, Suzuki T, Sato R, Kaga K, Kaga M, Fuse M
Low Urin Tract Symptoms. 2017 Sep; 29. doi: 10.1111/luts.12197.


6. Pulsed Magnetic Stimulation for Stress Urinary Incontinence: 1-Year Followup Results.
Lim R, Liong ML, Leong WS, Karim Khan NA, Yuen KH.
J Urol. 2017 May;197(5):1302-1308. doi: 10.1016/j.juro.2016.11.091


7. Effect of pulsed magnetic stimulation on quality of life of female patients with stress urinary incontinence: an IDEAL-D stage 2b study.
Lim R, Liong ML, Leong WS, Karim Khan NA, Yuen KH.
Int Urogynecol J. 2018 Apr;29(4):547-554. doi: 10.1007/s00192-017-3439- 8. Epub 2017 Aug 8.


8. Assessment of the Short-Term Effects after High-Inductive Electromagnetic Stimulation of Pelvic Floor Muscles: A Randomized, Sham-Controlled Study.
Ptaszkowski K, Malkiewicz B, Zdrojowy M, Ptaszkowska L, Paprocka-Borowicz M.
J Clin Med. 2020 Mar;9(3):874.doi: 10.3390/jcm9030874.


9. High-power Magnetotherapy: A new Weapon in Urinary Incontinence?
Vadalà M, Palmieri B, Malagoli A, Laurino C.
Low Urin Tract Symptoms. 2018 Sep;10(3):266-270.doi: 10.1111/luts.12174. Epub 2017 Jun 18.


10. Functional magnetic stimulation for mixed urinary incontinence.
But I, Faganelj M, Sostaric A.
J Urol. 2005 May;173(5):1644-6.


11. A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data
Silantyeva E, Zarkovic D, Astafeva E, Soldatskaia R, Orazov M, Belkovskaya M, Kurtser M.
Female Pelvic Med Reconstr Surg. 2020 Jan; .doi: 10.1097/SPV.0000000000000807.Online ahead of print.

12. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life.
Samuels J.B, Pezzella A, Berenholz J, Alinsod, R.
Lasers Surg Med. 2019 Nov;51(9):760-766.doi: 10.1002/lsm.23106.

Faecal incontinence

A randomised controlled trial (RCT) investigating the effect of FMS on postpartum faecal incontinence found that treatment with FMS was significantly more effective than PFMT alone. In addition to PFMT, in FMS training a frequency of 50 Hz was delivered to the pelvic floor muscles for 30 minutes, three times a week for two consecutive months. [1]. Pilot studies also show positive treatment effects of FMS for faecal incontinence with reduced faecal incontinence scores, improved quality of life and significantly improved recruitment of the relevant muscles after treatment [2, 3].

References:
1. The Effect of Magnetic Stimulation of Pelvic Floor on Treating Postpartum Fecal Incontinence.
Sabbour A, Shafik A.
Fac. Ph. Th. Cairo Univ. 2009 July; 14(2):155-164


2. Effects of extracorporeal magnetic stimulation in fecal incontinence
Brusciano L, Gambardella C, Gualitieri G, Terracciano G, Tolone S, Schiano di Visconte M, Grossi U, del Genio G, Docimo L.
Open Med
2020; 15:57-64. https://doi.org/10.1515/med-2020-0009


3. A Pilot Study of Extracorporeal Magnetic Stimulation of the Pelvic Floor for the Treatment of Women With Fecal Incontinence and Underactive Pelvic Floor Muscles.
Shobeiri SA, Chesson RR, West EC, Shott S, Hoyte L
Pelvic Medicine & Surgery. 2007 Feb; 13(1):19-26

Pain (back pain, pelvic pain, period pain)

The effects of magnetic stimulation have also been studied at the cellular and physiological level. Recently, FMS has been shown to affect primary sensory neurons, which may explain the analgesic effects observed [1].

FMS is able to improve sensory-motor impairments and reduce both acute and chronic pain. This is demonstrated in studies that investigated the effect of Repetitive Peripheral Magnetic Stimulation (RPMS) in patients with acute and chronic pain conditions [2, 3, 4, 5, 6, 7, 8, 9,10]. Post-treatment and at the three-month follow-up examination, RPMS significantly reduced pain and improved functional ability in musculoskeletal and neurological pain conditions of an acute and chronic nature [2]. A randomised, sham-controlled trial of RPMS in an acute back pain population also showed an immediate and sustained pain relief effect, as well as earlier functional recovery [3]. In chronic back pain, RPMS has been shown to be a positive adjunct to motor training, improving on the gains achieved via training alone (and the sham control) [4]. Studies have also shown that FMS is effective in the treatment of neuropathic pain [5, 6, 7]. For example, one RCT demonstrated that a single FMS session resulted in significant improvement in pain associated with lumbar spondylosis[5]. Savulescu et al. (2021) found that FMS alone brought about a significant improvement in pain associated with lumbar radiculopathy and that functional recovery was even more pronounced when combined with a physical rehabilitation programme [6]. FMS in combination with other physiotherapy approaches also improved outcomes in patients with degenerative or traumatic sciatica [7]. RPMS at 20 Hz administered to myofascial trigger points in the trapezius muscle also significantly reduced pain and improved the range of motion. [8].

A report on clinical outcomes in a population of individuals with pelvic pain, of varying gynaecological origin, found that pain was significantly reduced after one to three sessions in 90% of cases [9]. In a recent study, FMS significantly reduced pain, increased quality of life and increased progesterone levels in individuals with primary dysmenorrhoea (painful menstruation) when compared to an aerobic exercise programme [10]. The production of uterine prostaglandins has been identified as a mechanism underlying dysmenorrhoea, as they stimulate cramps and ischaemia. The higher progesterone levels in the FMS group are probably responsible for the reduced menstrual pain, as progesterone inhibits prostaglandin synthesis [10].

References:
1. Acute exposure to high-induction electromagnetic field affects activity of model peripheral sensory neuron
Prucha J, Krusek J, Dittert I, Sinica V, Kadkova A, Vlachova V.
J Cell Mol Med. 2018 Feb;22(2):1355-1362.


2. Repetitive Peripheral Magnetic Stimulation as Pain Management Solution in Musculoskeletal and Neurological Disorders – A Pilot Study.
Zarkovic D & Kazalakova K.
International Journal of Physiotherapy, 2016, Vol. 3(6), p. 671–675


3. Effects of Repetitive Peripheral Magnetic Stimulation on Patients With Acute Low Back Pain: A Pilot Study.
Lim Y, Song JM, Choi E, Lee JW.
Ann Rehabil Med 2018;42(2):229-238 pISSN: 2234-0645 • eISSN: 2234-0653 https://doi.org/10.5535/arm.2018.42.2.229

4. Repetitive peripheral magnetic neurostimulation of multifidus muscles combined with motor training influences spine motor control and chronic low back pain.
Massé-Alarie H, Beaulieu LD, Preuss R, Schneider C.
Clin Neurophysiol. 2017 Mar;128(3):442-453


5. A Randomized, Placebo-Controlled Trial of Repetitive Spinal Magnetic Stimulation in Lumbosacral Spondylotic Pain.
Lo YL, Fook-Chong S, Huerto AP, George PM.
Pain Medicine. 2011; 12:1041–1045 Wiley Periodicals, Inc.


6. Repetitive Peripheral Magnetic Stimulation (rPMS)
in Subjects With Lumbar Radiculopathy: An Electromyography-guided Prospective, Randomized Study
Savulescu SE, Berteanu M, Filipescu M, Beiu C, Mihai M, Popa LG, Popescu SI, Balescu I, Bacalbasa N, Popescu M.
in vivo 35: 623-627 (2021) doi:10.21873/invivo.12300


7. The Effectiveness of the Functional Magnetic Stimulation Therapy in Treating Sciatica Syndrome.
Radaković T & Radaković M
Open Journal of Therapy and Rehabilitation. 2015 Aug;3, 63-69
Published Online in SciRes, http://dx.doi.org/10.4236/ojtr.2015.33009


8.Therapeutic effects of peripheral repetitive magnetic stimulation on myofascial pain syndrome
Smania N, Corato E, Fiaschi A, Pietropoli P, Aglioti SM, Tinazzi M.
Clin Neurophysiol. 2003 Feb;114(2):350-8.


9. Electrochemical therapy of pelvic pain: effects of pulsed electromagnetic fields (PEMF) on tissue trauma.
Jorgensen WA, Frome BM, Wallach C.
Eur J Surg Suppl. 1994;(574):83-6.


10. Effect of Pulsed Electromagnetic Field Versus Aerobic Exercise on Primary Dysmenorrhea.
Awad AM, Elbandrawy AM, Lbrandrawy, Gabr, AA, Abd El Hamid, AH.
Med. J. Cairo Univ. 2020 Dec; Vol. 88(5):2165-2175

Postpartum recovery

Pelvic floor dysfunction (PFD) significantly affects quality of life, and its occurrence is strongly associated with pregnancy and childbirth. Silantyeva et al. (2020) found that in postpartum women, Functional Magnetic Stimulation (FMS) was significantly more effective than electrical stimulation in treating PFD. Improved pelvic floor muscle strength and endurance, as measured by electromyography, could be demonstrated, which is thought to explain the observed reduction in incontinence as well as sex-related PFD symptoms [1, 2].

FMS has also been shown to be effective in the treatment of postpartum pelvic organ prolapse (POP) when offered in combination with electrical stimulation and biofeedback [3]. This retrospective analysis of 90 patients with postpartum POP who received this treatment combination, including 10 sessions of FMS administered at 30 Hz for 20 minutes, showed a significant reduction in the POP stage (100% of patients were able to reduce by at least one POP stage!). PFM strength, measured by digital assessment and EMG, and PFM awareness also increased significantly after treatment [3].

A ‘Randomised Controlled Trial’ (RCT) investigating the effect of FMS on postpartum faecal incontinence found that the group receiving FMS was significantly more effective than PFMT alone. FMS training stimulated the pelvic floor muscles at a frequency of 50 Hz for 30 minutes, three times a week for two consecutive months in addition to PFMT [4].

Magnetic stimulation has been shown to improve muscle contractile function and muscle recovery by minimising inflammatory infiltrates and scar tissue formation after trauma [5]. Therefore, magnetic stimulation may also help in the strengthening and healing process of the pelvic floor muscles after pregnancy and childbirth.

References:
1. Electromyographic Evaluation of the Pelvic Muscles Activity After High-Intensity Focused Electromagnetic Procedure and Electrical Stimulation in Women With Pelvic Floor Dysfunction
Silantyeva E, Dragana Z, Ramina S, Evgeniia A, Orazov M.
Sex Med. 2020 Jun;8(2):282-289. doi: 10.1016/j.esxm.2020.01.004. Epub 2020 Mar 4


2. A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data
Silantyeva E, Zarkovic D, Astafeva E, Soldatskaia R, Orazov M, Belkovskaya M, Kurtser M.
Female Pelvic Med Reconstr Surg. 2020 Jan 25. doi: 10.1097/SPV.0000000000000807.Online ahead of print


3. Efficacy of pelvic floor magnetic stimulation combined with electrical stimulation on postpartum pelvic organ prolapse: a retrospective study.
Zhang L, Juan X, Tang, J.
Pelviperineology. 2020;39(1):18-23


4. The Effect of Magnetic Stimulation of Pelvic Floor on Treating Postpartum Fecal Incontinence.
Sabbour A, Shafik A.
Fac. Ph. Th. Cairo Univ. 2009 July; 14(2):155-164


5. Magnetic stimulation supports muscle and nerve regeneration after trauma in mice.
Stölting MN, Arnold AS, Haralampieva D, Handschin C, Sulser T, Eberli D.
Muscle Nerve. 2016 Apr;53(4):598-607.

Sexual function (incl. erectile dysfunction)

Male erectile dysfunction:
A controlled study of patients with erectile dysfunction (ED) demonstrated the efficacy of FMS in increasing intracorporeal pressure and producing a full penile erection. FMS stimulated at a frequency of 20 Hz for 10 minutes over the dorsal portion of the penis base, which is thought to have stimulated the cavernous nerve [1]. Three weeks of FMS at a frequency of 18 Hz also significantly improved erection intensity and duration, sexual activity, libido and general well-being in men suffering from ED and orgasmic dysfunction compared to a placebo control group [2].

References:
1. Magnetic stimulation of the cavernous nerve for the treatment of erectile dysfunction in humans.
Shafik A, el-Sibai O, Shafik AA
Int J Impot Res. 2000 Jun;12(3):137-41


2. Impulse Magnetic-Field Therapy for Erectile Dysfunction: A Double-Blind,Placebo-Controlled Study
Pelka R, Jaenicke C, Gruenwald J
dv Ther. Jan-Feb 2002;19(1):53-60.


Female sexual function:
FMS improved sexual function in couples when the female partner with stress urinary incontinence was treated. Improvements in sexual function were demonstrated not only in treated women but also in their male partners across multiple dimensions, e.g. improvement in total sexual function score with concomitant reduction in premature ejaculation, reduction in erectile dysfunction, improvement in sexual satisfaction and increase in frequency of sexual intercourse [1]. In another study on FMS for urinary incontinence, increased sexual desire and more intense orgasms were reported as additional benefits of FMS treatment [2].

References:
1. Effect of pulsed magnetic stimulation on sexual function in couples with female stress urinary incontinence partners
Lim R, Liong ML, Lau YK, Leong WS, Khan, NAKK, Yuen KH.
Journal of Sex & Marital Therapy, 2017 July; DOI: 10.1080/0092623X.2017.1348417


2. Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life.
Samuels J.B, Pezzella A, Berenholz J, Alinsod, R.
Lasers Surg Med. 2019 Nov;51(9):760-766.doi: 10.1002/lsm.23106.

Prostate

Benign prostatic hyperplasia:
Functional magnetic stimulation (FMS) has a significant impact on the treatment of benign prostatic hyperplasia (BPH) [1,2,3,4]. A double-blind, randomised controlled trial showed significant improvement in subjective symptoms assessed by the International Prostate Symptom Score (IPSS), as well as a reduction in prostate-specific antigen and white blood cell count after FMS treatment. These benefits were significant both when FMS was used alone and in combination with pelvic floor and aerobic therapy compared to a placebo treatment group [1]. Magnetic therapy, together with vibratory stimulation, when applied to the perineal area for 30 minutes daily, improved micturition symptoms, decreased urinary urgency and improved quality of life in BPH patients within the first week of treatment [2]. In a study of 27 men, regular FMS treatment with 4-12Hz showed a reduction in prostate volume and improvement in lower urinary tract symptoms (IPSS) after one month, with no side effects on normal hormonal or sexual function [3].

In a study comparing the FMS with the pharmacologic (α-blocker alfuzosin) effects, the group treated with FMS showed significant improvement in prostatic hyperplasia symptoms, including improvement in the IPSS, reduced prostate volume, reduced residual urine and improved urinary flow rate [4]. These positive results persisted in all patients treated with FMS after one year, which contrasts strongly with the fact that all patients treated with pharmacology underwent prostatectomy within one month of treatment [4].

Data from a study on the effects of FMS on the prostate in dogs showed a significant reduction in prostate volume, without affecting sperm quality, testosterone levels or libido [5]. An improvement in blood flow could also be observed. This is a possible mechanism by which FMS improves BPH [5].

Benign Prostatic Hyperplasia (BPH) References:
1. Pulsed electromagnetic field with or without exercise therapy in the treatment of benign prostatic hyperplasia.
Elgohary HM & Tantawy SA.
J PhysTher Sci. 2017; 29: 1305-1310.


2. Possible Applications of Electromagnetic Fields in the Treatment of Symptoms Related to Benign Prostatic Hyperplasia.
Brardi S, Biandolino P, Giovannelli V, Belba A, Ponchietti R, Cevenini G.
Am J Urol Res. 2020 April;5(1): 006-010.


3. Therapeutic use of pulsed electromagnetic field therapy reduces prostate volume and lower urinary tract symptoms in benign prostatic hyperplasia.
Tenuta M, Tarsitano MG, Mazzotta P et al. 
Andrology. 2020; 8:1076-1085.


4. Effects of pulsed electromagnetic fields on benign prostate hyperplasia.
Giannakopoulos XK, Giotis C, Karkabounas SC, Verginadis II, Simos YV, Peschos D, Evangelou AM.
Int Urol Nephrol. 2011; 43:955–960. Doi:10.1007/s11255-011-9944-7


5. Effect of Pulsed Electromagnetic Field Therapy on Prostate Volume and Vascularity in the Treatment of Benign Prostatic Hyperplasia: A Pilot Study in a Canine Model.
Leoci R, Aiudi G, Silvestre F, Lissner E, Lacalandra GM.
The Prostate. 2014 June; 74:1132-1141. Doi: 10.1002/pros.22829


After a prostatectomy
Two studies compared the clinical effects of Functional Magnetic Stimulation (FMS) and Functional Electrical Stimulation (FES) on urinary incontinence after radical prostatectomy [1, 2]. Both FMS and FES resulted in earlier continence compared to a control group that only performed pelvic floor muscle exercises [2]. FMS was shown to have a clinically relevant advantage over FES in reducing stress urinary incontinence after radical prostatectomy [1].

References:
1. Electrical stimulation versus extracorporeal magnetic innervation for urinary incontinence after radical prostatectomy.
Terzoni S, Montanari E, Mora C, Ricci C, Destrebecq AL.
Int J of Urol Nurs. 2013; 7(3): 121–125. doi: 10.1111/ijun.12008


2. COMPARATIVE STUDY OF EFFECTS OF EXTRACORPOREAL MAGNETIC INNERVATION VERSUS ELECTRICAL STIMULATION FOR URINARY INCONTINENCE AFTER RADICAL PROSTATECTOMY
Yokoyama T, Nishiguchi J, Watanabe T, Nose H, Nozaki K, Fujita O, Inoue M, Kumon H.
UROLOGY 2004. 63: 264-267. doi:10.1016/j.urology.2003.09.024


Chronic Prostatitis:
FMS improves symptoms of chronic prostatitis and chronic pelvic pain syndrome in men who do not respond to pharmacological treatment [1]. This was demonstrated by a significant improvement in pain, lower urinary tract symptoms and quality of life at the end of treatment. These improvements persisted at the 24-week follow-up [1].

Chronic Prostatitis References:
1. The Efficacy of Extracorporeal Magnetic Stimulation for Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients Who Do Not Respond to Pharmacotherapy.
Kim TH, Han DH, Cho WJ, Lee HS, You HW, Park CM, Ryu D, Lee K.
UROLOGY. 2013; 82: 894-898