Magnetic Stimulation for Stress Urinary Incontinence: Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2015 Jun 22

PMID 26093910

Citations 13

Authors

Renly Lim

Men Long Liong

Wing Seng Leong

Nurzalina Abdul Karim Khan

Kah Hay Yuen

Affiliations

Soon will be listed here.

Abstract

Background: There is currently a lack of randomized, sham-controlled trials that are adequately powered, using validated outcomes, to allow for firm recommendations on the use of magnetic stimulation for stress urinary incontinence. We report a protocol of a multicenter, randomized, double-blind, sham-controlled parallel-group trial to evaluate the efficacy of magnetic stimulation for stress urinary incontinence.

Methods/design: One hundred twenty subjects with stress urinary incontinence will be randomized in a 1:1 allocation to either active or sham magnetic stimulation using computer-generated, permuted blocks of variable sizes. Subjects will receive 2 sessions of magnetic stimulation per week for 8 weeks (16 sessions total). The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form at the end of treatment sessions compared with baseline. Secondary outcomes include cure, stress urinary incontinence-related symptoms (incontinence episode frequency, urine loss in 1-hour pad test, pelvic floor muscle strength) and health-related quality of life (Patient Global Impression of Improvement, International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life and EQ-5D). The safety of magnetic stimulation will also be assessed. Besides evaluation of clinical treatment effectiveness, cost-effectiveness analysis using patient-reported outcomes will be performed.

Discussion: This trial is designed to provide pending outcome information on this non-invasive treatment option. We intend to acknowledge the existing flaws in previous clinical trials and determine conclusively whether magnetic stimulation is effective for stress urinary incontinence.

Trial Registration: ClinicalTrials.gov Identifier: NCT01924728. Date of Registration: 14 August 2013.

Citing Articles

Is the High-Intensity Focused Electromagnetic Energy an Effective Treatment for Urinary Incontinence in Women?.

Tosun H, Akinsal E, Sonmez G, Baydilli N, Demirci D Ther Clin Risk Manag. 2024; 20:811-816.

PMID: 39640007 PMC: 11619107. DOI: 10.2147/TCRM.S478919.

Effects of central-peripheral FMS on urinary retention after spinal cord injury: a pilot randomized controlled trial protocol.

Dong L, Tao X, Gong C, Long Y, Xiao L, Luo Y Front Neurol. 2024; 14:1274203.

PMID: 38249751 PMC: 10797019. DOI: 10.3389/fneur.2023.1274203.

The Effects of Extracorporeal Magnetic Innervation in the Treatment of Women with Urinary Incontinence: A Systematic Review.

Strojek K, Straczynska A, Radziminska A, Weber-Rajek M J Clin Med. 2023; 12(17).

PMID: 37685522 PMC: 10487770. DOI: 10.3390/jcm12175455.

The Role of Gene Expression in Stress Urinary Incontinence: An Integrative Review of Evidence.

Milicic I, Mikus M, Vrbanic A, Kalafatic D Medicina (Kaunas). 2023; 59(4).

PMID: 37109658 PMC: 10142382. DOI: 10.3390/medicina59040700.

Technological Improvement Rates and Evolution of Energy-Based Therapeutics.

Basnet S, Magee C Front Med Technol. 2022; 3:714140.

PMID: 35047947 PMC: 8757806. DOI: 10.3389/fmedt.2021.714140.

References

Hundley A, Wu J, Visco A . A comparison of perineometer to brink score for assessment of pelvic floor muscle strength. Am J Obstet Gynecol. 2005; 192(5):1583-91. DOI: 10.1016/j.ajog.2004.11.015. View

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. View

Lim R, Lee S, Tan P, Liong M, Yuen K . Efficacy of electromagnetic therapy for urinary incontinence: A systematic review. Neurourol Urodyn. 2014; 34(8):713-22. DOI: 10.1002/nau.22672. View

Galloway N, Sand P, Appell R, Russell H, Carlin S . Update on extracorporeal magnetic innervation (EXMI) therapy for stress urinary incontinence. Urology. 2000; 56(6 Suppl 1):82-6. DOI: 10.1016/s0090-4295(00)00686-5. View

Yalcin I, Bump R . Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003; 189(1):98-101. DOI: 10.1067/mob.2003.379. View

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. View

Schultz S, Kopec J . Impact of chronic conditions. Health Rep. 2003; 14(4):41-53. View

Avery K, Donovan J, Peters T, 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. View

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

10.

Krueger C, Tian L . A comparison of the general linear mixed model and repeated measures ANOVA using a dataset with multiple missing data points. Biol Res Nurs. 2004; 6(2):151-7. DOI: 10.1177/1099800404267682. View

11.

Abrams P, Blaivas J, Stanton S, Andersen J . The standardisation of terminology of lower urinary tract function. The International Continence Society Committee on Standardisation of Terminology. Scand J Urol Nephrol Suppl. 1988; 114:5-19. View

12.

Diokno A, Yuhico Jr M . Preference, compliance and initial outcome of therapeutic options chosen by female patients with urinary incontinence. J Urol. 1995; 154(5):1727-30; discussion 1731. View

13.

Bump R, Mattiasson A, Bo K, Brubaker L, DeLancey J, Klarskov P . The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996; 175(1):10-7. DOI: 10.1016/s0002-9378(96)70243-0. View

14.

Kelleher C, Cardozo L, Khullar V, Salvatore S . A new questionnaire to assess the quality of life of urinary incontinent women. Br J Obstet Gynaecol. 1998; 104(12):1374-9. DOI: 10.1111/j.1471-0528.1997.tb11006.x. View

15.

Galloway N, Sand P, Appell R, Russell H, Carlan S . Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology. 1999; 53(6):1108-11. DOI: 10.1016/s0090-4295(99)00037-0. View

16.

Quek P . A critical review on magnetic stimulation: what is its role in the management of pelvic floor disorders?. Curr Opin Urol. 2005; 15(4):231-5. DOI: 10.1097/01.mou.0000172395.54643.4d. View

17.

Abrams P, Avery K, Gardener N, Donovan J . The International Consultation on Incontinence Modular Questionnaire: www.iciq.net. J Urol. 2006; 175(3 Pt 1):1063-6. DOI: 10.1016/S0022-5347(05)00348-4. View

18.

Frawley H, Galea M, Phillips B, Sherburn M, Bo K . Reliability of pelvic floor muscle strength assessment using different test positions and tools. Neurourol Urodyn. 2005; 25(3):236-242. DOI: 10.1002/nau.20201. View

19.

Klovning A, Avery K, Sandvik H, Hunskaar S . Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodyn. 2009; 28(5):411-5. DOI: 10.1002/nau.20674. View

20.

Haylen B, Ridder D, Freeman R, Swift S, Berghmans B, Lee J . An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Neurourol Urodyn. 2009; 29(1):4-20. DOI: 10.1002/nau.20798. View