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Erschienen in: International Urogynecology Journal 4/2018

08.08.2017 | Original Article

Effect of pulsed magnetic stimulation on quality of life of female patients with stress urinary incontinence: an IDEAL-D stage 2b study

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

Erschienen in: International Urogynecology Journal | Ausgabe 4/2018

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Abstract

Introduction and hypothesis

We evaluated the effects of pulsed magnetic stimulation (PMS) on overall and different aspects of quality of life (QoL) in female patients with stress urinary incontinence (SUI).

Methods

This study involved 120 female SUI subjects aged ≥21 years old randomized to either active or sham PMS. Treatment involved two PMS sessions per week for 2 months (16 sessions). After 2 months, subjects could opt for 16 additional sessions regardless of initial randomization. The primary response criterion was a 7-point reduction in the total score of the International Consultation on Incontinence Questionnaire-Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol) questionnaire. Follow-ups were conducted at months 1, 2, 5, 8, and 14.

Results

At 2 months, 35 out of 60 (58%) subjects in the active arm and 21 out of 60 (21%) in the sham arm were treatment responders (≥7-point reduction) (p = 0.006). There was a significant difference in changes in the mean ± SE ICIQ-LUTSqol total score between the active and sham arms (Mdiff = −8.74 ± 1.25 vs −4.10 ± 1.08, p = 0.006). At 1-year post-treatment, regardless of number of PMS sessions (16 or 32 sessions), subjects who received active PMS (63 out of 94, 67%) were more likely to be treatment responders compared with subjects who did not receive any active PMS (3 out of 12, 25%; p < 0.001). The impact of PMS treatment was the greatest on the “physical activities” domain.

Conclusions

PMS resulted in significant short- and long-term improvements in overall and various physical, social, and psychological aspects of QoL.
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Literatur
1.
Zurück zum Zitat 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. Neurourol Urodyn. 2010;29(1):4–20. doi:10.1002/nau.20798. 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. Neurourol Urodyn. 2010;29(1):4–20. doi:10.​1002/​nau.​20798.
4.
Zurück zum Zitat Abrams P, Smith AP, Cotterill N. The impact of urinary incontinence on health-related quality of life (HRQoL) in a real-world population of women aged 45–60 years: results from a survey in France, Germany, the UK and the USA. BJU Int. 2015;115(1):143–52. doi:10.1111/bju.12852.CrossRefPubMed Abrams P, Smith AP, Cotterill N. The impact of urinary incontinence on health-related quality of life (HRQoL) in a real-world population of women aged 45–60 years: results from a survey in France, Germany, the UK and the USA. BJU Int. 2015;115(1):143–52. doi:10.​1111/​bju.​12852.CrossRefPubMed
6.
Zurück zum Zitat Tennstedt SL, Fitzgerald MP, Nager CW, Xu Y, Zimmern P, Kraus S, et al. Quality of life in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(5):543–9. doi:10.1007/s00192-006-0188-5. Tennstedt SL, Fitzgerald MP, Nager CW, Xu Y, Zimmern P, Kraus S, et al. Quality of life in women with stress urinary incontinence. Int Urogynecol J Pelvic Floor Dysfunct. 2007;18(5):543–9. doi:10.​1007/​s00192-006-0188-5.
7.
8.
Zurück zum Zitat Goldberg RP, Sand PK. Electromagnetic pelvic floor stimulation for urinary incontinence and bladder disease. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):401–4.CrossRefPubMed Goldberg RP, Sand PK. Electromagnetic pelvic floor stimulation for urinary incontinence and bladder disease. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(6):401–4.CrossRefPubMed
9.
Zurück zum Zitat 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 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
10.
Zurück zum Zitat Funk RH, Knels L, Augstein A, Marquetant R, Dertinger HF. Potent stimulation of blood flow in fingers of volunteers after local short-term treatment with low-frequency magnetic fields from a novel device. Evid Based Complement Alternat Med. 2014;2014:543564. doi:10.1155/2014/543564.CrossRefPubMedPubMedCentral Funk RH, Knels L, Augstein A, Marquetant R, Dertinger HF. Potent stimulation of blood flow in fingers of volunteers after local short-term treatment with low-frequency magnetic fields from a novel device. Evid Based Complement Alternat Med. 2014;2014:543564. doi:10.​1155/​2014/​543564.CrossRefPubMedPubMedCentral
11.
Zurück zum Zitat 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.CrossRefPubMed 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.CrossRefPubMed
14.
Zurück zum Zitat Abrams P, Cardozo L, Wein A, Wagg A (2017) Incontinence: 6th International Consultation on Incontinence, Tokyo, September 2016. 6 ed. Bristol: ICUD. Abrams P, Cardozo L, Wein A, Wagg A (2017) Incontinence: 6th International Consultation on Incontinence, Tokyo, September 2016. 6 ed. Bristol: ICUD.
15.
16.
Zurück zum Zitat 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 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
17.
Zurück zum Zitat Manganotti P, Zaina F, Vedovi E, Pistoia L, Rubilotta E, D'Amico A, et al. Repetitive magnetic stimulation of the sacral roots for the treatment of stress incontinence: a brief report. Eura Medicophys. 2007;43(3):339–44. Manganotti P, Zaina F, Vedovi E, Pistoia L, Rubilotta E, D'Amico A, et al. Repetitive magnetic stimulation of the sacral roots for the treatment of stress incontinence: a brief report. Eura Medicophys. 2007;43(3):339–44.
18.
Zurück zum Zitat Gilling PJ, Wilson LC, Westenberg AM, McAllister WJ, Kennett KM, Frampton CM, et al. A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence. BJU Int. 2009;103(10):1386–90. doi:10.1111/j.1464-410X.2008.08329.x. Gilling PJ, Wilson LC, Westenberg AM, McAllister WJ, Kennett KM, Frampton CM, et al. A double-blind randomized controlled trial of electromagnetic stimulation of the pelvic floor vs sham therapy in the treatment of women with stress urinary incontinence. BJU Int. 2009;103(10):1386–90. doi:10.​1111/​j.​1464-410X.​2008.​08329.​x.
19.
Zurück zum Zitat Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ. 2016;353:i2372. doi:10.1136/bmj.i2372. Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P. IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ. 2016;353:i2372. doi:10.​1136/​bmj.​i2372.
21.
Zurück zum Zitat Nystrom E, Sjostrom M, Stenlund H, Samuelsson E. ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. 2015;34(8):747–51. doi:10.1002/nau.22657.CrossRefPubMed Nystrom E, Sjostrom M, Stenlund H, Samuelsson E. ICIQ symptom and quality of life instruments measure clinically relevant improvements in women with stress urinary incontinence. Neurourol Urodyn. 2015;34(8):747–51. doi:10.​1002/​nau.​22657.CrossRefPubMed
22.
Zurück zum Zitat 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 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
24.
Zurück zum Zitat Lim R, Liong ML, Lau YK, Yuen KH. Validity, reliability, and responsiveness of the ICIQ-UI SF and ICIQ-LUTSqol in the Malaysian population. Neurourol Urodyn. 2017;36(2):438–42. doi:10.1002/nau.22950.CrossRefPubMed Lim R, Liong ML, Lau YK, Yuen KH. Validity, reliability, and responsiveness of the ICIQ-UI SF and ICIQ-LUTSqol in the Malaysian population. Neurourol Urodyn. 2017;36(2):438–42. doi:10.​1002/​nau.​22950.CrossRefPubMed
25.
Zurück zum Zitat Ayeleke RO, Hay-Smith EJ, Omar MI. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Data Syst Rev. 2013;11:CD010551. doi:10.1002/14651858.CD010551.pub2. Ayeleke RO, Hay-Smith EJ, Omar MI. Pelvic floor muscle training added to another active treatment versus the same active treatment alone for urinary incontinence in women. Cochrane Data Syst Rev. 2013;11:CD010551. doi:10.​1002/​14651858.​CD010551.​pub2.
26.
Zurück zum Zitat 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 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
27.
Zurück zum Zitat Lagro-Janssen T, Smits A, Van Weel C. Urinary incontinence in women and the effects on their lives. Scand J Prim Health Care. 1992;10(3):211–6.CrossRefPubMed Lagro-Janssen T, Smits A, Van Weel C. Urinary incontinence in women and the effects on their lives. Scand J Prim Health Care. 1992;10(3):211–6.CrossRefPubMed
28.
Zurück zum Zitat World Health Organisation. Global recommendations on physical activity for health. Geneva: World Health Organisation; 2010. World Health Organisation. Global recommendations on physical activity for health. Geneva: World Health Organisation; 2010.
31.
Zurück zum Zitat Coyne KS, Kvasz M, Ireland AM, Milsom I, Kopp ZS, Chapple CR. Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States. Eur Urol. 2012;61(1):88–95. doi:10.1016/j.eururo.2011.07.049.CrossRefPubMed Coyne KS, Kvasz M, Ireland AM, Milsom I, Kopp ZS, Chapple CR. Urinary incontinence and its relationship to mental health and health-related quality of life in men and women in Sweden, the United Kingdom, and the United States. Eur Urol. 2012;61(1):88–95. doi:10.​1016/​j.​eururo.​2011.​07.​049.CrossRefPubMed
32.
Zurück zum Zitat McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105–12. doi:10.1016/S0140-6736(09)61116-8. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374(9695):1105–12. doi:10.​1016/​S0140-6736(09)61116-8.
34.
Zurück zum Zitat 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 Nursing. 2004;6(2):151–7. doi:10.1177/1099800404267682.CrossRef 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 Nursing. 2004;6(2):151–7. doi:10.​1177/​1099800404267682​.CrossRef
Metadaten
Titel
Effect of pulsed magnetic stimulation on quality of life of female patients with stress urinary incontinence: an IDEAL-D stage 2b study
verfasst von
Renly Lim
Men Long Liong
Wing Seng Leong
Nurzalina Abdul Karim Khan
Kah Hay Yuen
Publikationsdatum
08.08.2017
Verlag
Springer London
Erschienen in
International Urogynecology Journal / Ausgabe 4/2018
Print ISSN: 0937-3462
Elektronische ISSN: 1433-3023
DOI
https://doi.org/10.1007/s00192-017-3439-8

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