Top

International Urogynecology Journal

Published in:

01-07-2018 | Original Article

Patients’ perception and satisfaction with pulsed magnetic stimulation for treatment of female stress urinary incontinence

Authors: Renly Lim, Men Long Liong, Wing Seng Leong, Nurzalina Abdul Karim Khan, Kah Hay Yuen

Published in: International Urogynecology Journal | Issue 7/2018

Abstract

Introduction and hypothesis

We evaluated patients’ perception and satisfaction with nonsurgical pulsed magnetic stimulation (PMS) for treatment of female stress urinary incontinence (SUI) in a randomized, double-blind, sham-controlled trial.

Methods

Women with SUI (n = 120) were randomized to either active or sham PMS for 8 weeks (twice/week). Patients answered seven questions on their perception and acceptability, each measured on a 5-point Likert scale. Treatment satisfaction was assessed using two parameters: (i) the single-item question “Overall, please rate how satisfied you are with the treatment” and (ii) Patient Global Impression of Improvement (PGI-I). All adverse events were documented.

Results

A total of 115 patients completed treatments (active: n = 57, sham: n = 58). There were no significant differences between groups in all parameters regarding perception and acceptability (p > 0.05). In terms of treatment satisfaction, a significantly higher proportion of patients in the active group (n = 47/57, 82.4%) were either mostly or completely satisfied compared with those in the sham group (n = 27/58, 46.6%) ((p = 0.001). Similarly, a statistically significantly higher percentage of patients in the active group (n = 39/57, 68.4%) felt much or very much better compared with patients in the sham group (n = 11/58, 19.0%) as measured using the PGI-I (p < 0.001). Three (5.3%) patients in the active group and five (8.6%) in the sham group experienced adverse events (p = 0.72). Regardless of treatment arms, 109 (94.8%) patients would not consider surgical options even if they required further treatment for their condition.

Conclusion

PMS was well accepted, well tolerated, and resulted in a high treatment satisfaction among women with SUI.

Payne CK. Conservative Management of Urinary Incontinence: Behavioral and pelvic floor therapy, urethral and pelvic devices. In: McDougal WS, Wein AJ, Kavoussi LR, Novick AC, Partin AW, Peter CA, Ramchandani P, editors. Campbell Walsh urology. 10th ed. Philadelphia: W.B. Saunders; 2012. p. 2003–25. doi:10.1016/b978-1-4160-6911-9.00069-4.CrossRef

Abrams P, Cardozo L, Wein A, Wagg A. Incontinence: 6th International Consultation on Incontinence, Tokyo, September 2016. ICUD, 6th ed.; 2017.

Lim R, Liong ML, Leong WS, Khan NAK, Yuen KH. Effect of stress urinary incontinence on sexual function of couples and quality of life of the patients. J Urol. 2016; doi:10.1016/j.juro.2016.01.090.

Dumoulin C, Hay-Smith J, Habée-Séguin GM, Mercier J. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a short version Cochrane systematic review with meta-analysis. Neurourol Urodyn. 2015;34(4):300–8. doi:10.1002/nau.22700.CrossRefPubMed

Lipp A, Shaw C, Glavind K. Mechanical devices for urinary incontinence in women. Cochrane Database Syst Rev. 2011;7:CD001756. doi:10.1002/14651858.CD001756.pub5.CrossRef

Herbison GP, Dean N. Weighted vaginal cones for urinary incontinence. Cochrane Database Syst Rev. 2013;7:CD002114. doi:10.1002/14651858.CD002114.pub2.CrossRef

Ford Abigail A, Rogerson L, Cody June D, Ogah J. Mid-urethral sling operations for stress urinary incontinence in women. Cochrane Database Syst Rev. 2015;7:CD006375. doi:10.1002/14651858.CD006375.pub3.CrossRef

Diokno A, Yuhico M Jr. Preference, compliance and initial outcome of therapeutic options chosen by female patients with urinary incontinence. J Urol. 1995;154(5):1727–31.CrossRefPubMed

Karantanis E, Parsons M, Blackwell A, Robinson D, Cardozo L, Moore KH, et al. Women’s treatment preferences for stress urinary incontinence-physiotherapy or surgery. Aust N Z Continence J. 2014;20(2):34–6. 38-40, 42

10.

Paddison K. Complying with pelvic floor exercises: a literature review. Nurs Stand. 2002;16(39):33–8. doi:10.7748/ns2002.06.16.39.33.c3209.CrossRefPubMed

11.

Frawley HC, McClurg D, Mahfooza A, Hay-Smith J, Dumoulin C. Health professionals’ and patients’ perspectives on pelvic floor muscle training adherence—2011 ICS state-of-the-science seminar research paper IV of IV. Neurourol Urodyn. 2015;34(7):632–9. doi:10.1002/nau.22774.CrossRefPubMed

12.

Schreiner L, dos Santos TG, de Souza ABA, Nygaard CC, da Silva Filho IG. Electrical stimulation for urinary incontinence in women: a systematic review. Int Braz J Urol. 2013;39(4):454–64.CrossRefPubMed

13.

Markov MS. Pulsed electromagnetic field therapy history, state of the art and future. Environmentalist. 2007;27(4):465–75. doi:10.1007/s10669-007-9128-2.CrossRef

14.

Bickford RG, Fremming B. Neuronal stimulation by pulsed magnetic fields in animals and man. In: Digest of the 6th Internat. Conf. Medical Electronics and Biological Engineering; 1965. p. 112.

15.

Galloway NT, El-Galley RE, Sand PK, Appell RA, Russell HW, Carlan SJ. Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology. 1999;53(6):1108–11.CrossRefPubMed

16.

Lim R, Liong ML, Leong WS, Khan NAK, Yuen KH. Randomized controlled trial of pulsed magnetic stimulation for stress urinary incontinence: 1-year results. J Urol. 2017;197(5):1302–8. doi:10.1016/j.juro.2016.11.091.CrossRefPubMed

17.

Lim R, Lee SWH, Tan PY, Liong ML, Yuen KH. Efficacy of electromagnetic therapy for urinary incontinence: a systematic review. Neurourol Urodyn. 2015;34(8):713–22. doi:10.1002/nau.22672.CrossRefPubMed

18.

Lim R, Liong ML, Leong WS, Khan NAK, Yuen KH. Magnetic stimulation for stress urinary incontinence: study protocol for a randomized controlled trial. Trials. 2015;16:279. doi:10.1186/s13063-015-0803-1.CrossRefPubMedPubMedCentral

19.

Haylen BT, de Ridder D, Freeman RM, Swift SE, Berghmans B, Lee J, et al. An international urogynecological association (IUGA)/international continence society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J. 2010;21:5–26. doi:10.1002/nau.20798.CrossRefPubMed

20.

Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322–30. doi:10.1002/nau.20041.CrossRefPubMed

21.

Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996;175(1):10–7.CrossRefPubMed

22.

Wright P, Haybittle J. Design of forms for clinical trials (1). Br Med J. 1979;2(6189):529–30.CrossRefPubMedPubMedCentral

23.

Wright P, Haybittle J. Design of forms for clinical trials (2). Br Med J. 1979;2(6190):590–2.CrossRefPubMedPubMedCentral

24.

Wright P, Haybittle J. Design of forms for clinical trials (3). Br Med J. 1979;2(6191):650–1.CrossRefPubMedPubMedCentral

25.

Likert R. A technique for the measurement of attitudes. Arch Psychol. 1932;22:140.

26.

Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003;189(1):98–101. doi:10.1067/mob.2003.379.CrossRefPubMed

27.

Galloway NT, El-Galley RE, Sand PK, Appell RA, Russell HW, Carlin SJ. Update on extracorporeal magnetic innervation (EXMI) therapy for stress urinary incontinence. Urology. 2000;56(6 Suppl 1):82–6.CrossRefPubMed

28.

Fujishiro T, Enomoto H, Ugawa Y, Takahashi S, Ueno S, Kitamura T. Magnetic stimulation of the sacral roots for the treatment of stress incontinence: an investigational study and placebo controlled trial. J Urol. 2000;164(4):1277–9.CrossRefPubMed

29.

Yamanishi T, Yasuda K, Suda S, Ishikawa N, Sakakibara R, Hattori T. Effect of functional continuous magnetic stimulation for urinary incontinence. J Urol. 2000;163(2):456–9.CrossRefPubMed

30.

Yokoyama T, Fujita O, Nishiguchi J, Nozaki K, Nose H, Inoue M, et al. Extracorporeal magnetic innervation treatment for urinary incontinence. Int J Urol. 2004;11(8):602–6. doi:10.1111/j.1442-2042.2004.00857.x.CrossRefPubMed

31.

Lee JSHJY, Kim MH, Seo JT. Comparative study of the pelvic floor magnetic stimulation with BIOCON-2000TM in female urinary incontinence patients. Korean J Urol. 2004;45(5):438–43.

32.

Unsal A, Saglam R, Cimentepe E. Extracorporeal magnetic stimulation for the treatment of stress and urge incontinence in women--results of 1-year follow-up. Scand J Urol Nephrol. 2003;37(5):424–8. doi:10.1080/00365590310021258.CrossRefPubMed

33.

Bakar Y, Cinar Ozdemir O, Ozengin N, Duran B. The use of extracorporeal magnetic innervation for the treatment of stress urinary incontinence in older women: a pilot study. Arch Gynecol Obstet. 2011;284(5):1163–8. doi:10.1007/s00404-010-1814-5.CrossRefPubMed

34.

Labrie J, Berghmans BL, Fischer K, Milani AL, van der Wijk I, Smalbraak DJ, et al. Surgery versus physiotherapy for stress urinary incontinence. N Engl J Med. 2013;369(12):1124–33. doi:10.1056/NEJMoa1210627.CrossRefPubMed

35.

Richter HE, Burgio KL, Brubaker L, Nygaard IE, Ye W, Weidner A, et al. Continence Pessary compared with Behavioral therapy or combined therapy for stress incontinence: a randomized controlled trial. Obstet Gynecol. 2010;115(3):609–17. doi:10.1097/AOG.0b013e3181d055d4.CrossRefPubMedPubMedCentral

Title: Patients’ perception and satisfaction with pulsed magnetic stimulation for treatment of female stress urinary incontinence
Authors: Renly Lim
Men Long Liong
Wing Seng Leong
Nurzalina Abdul Karim Khan
Kah Hay Yuen
Publication date: 01-07-2018
Publisher: Springer London
Published in: International Urogynecology Journal / Issue 7/2018
Print ISSN: 0937-3462
Electronic ISSN: 1433-3023
DOI: https://doi.org/10.1007/s00192-017-3425-1

At a glance: The STEP trials

Springer Medicine

Patients’ perception and satisfaction with pulsed magnetic stimulation for treatment of female stress urinary incontinence

Abstract

Introduction and hypothesis

Methods

Results

Conclusion

At a glance: The STEP trials

Springer Medicine

Abstract

Introduction and hypothesis

Methods

Results

Conclusion

Please log in to get access to this content

Other articles of this Issue 7/2018

Evaluation of coital incontinence by electronic questionnaire: prevalence, associations and outcomes in women attending a urogynaecology clinic

Counseling in urogynecology: A difficult task, or simply good surgeon–patient communication?

Laparoscopic implantation of electrodes for bilateral neuromodulation of the pudendal nerves and S3 nerve roots for treating pelvic pain and voiding dysfunction

Lower urinary tract symptoms that predict microscopic pyuria

Morbidity rate and medical utilization in interstitial cystitis/painful bladder syndrome

Quality of randomized controlled trials published in the International Urogynecology Journal 2007–2016