Skip to main content

Advertisement

SpringerLink
Log in

A prospective randomised double-blind controlled trial evaluating the effect of trans-sacral magnetic stimulation in women with overactive bladder

  • Original Article
  • Published:
International Urogynecology Journal Aims and scope Submit manuscript

Abstract

Overactive bladder (OAB) is a prevalent condition with 16% of adults having one or more symptoms that significantly affect quality of life. Transcutaneous electrical nerve stimulation and neuromodulators have had success in treating OAB but are expensive, invasive, and sometimes cumbersome. We developed an alternative neuromodulatory technique that involves electromagnetic stimulation of the sacral nerve roots with a portable electromagnetic device to produce trans-sacral stimulation of the S3 and S4 sacral nerve roots. The aim of this study was to evaluate the impact of this device on OAB symptoms in women with a prospectively randomised double-blind controlled study. Following a power analysis, women with symptoms of OAB were prospectively recruited with ethical approval for randomisation to an active treatment (n = 33) or placebo group (n = 30) in a double-blind trial. The patient, at home, used the belt device daily for 20 min over 12 weeks. Outcome measures included a 3-day voiding diary, 1 h pad test, visual analogue score (VAS) for symptom impact (0–100%), Kings Health Questionnaire (KHQ) and Australian Quality of Life questionnaire (AQOL) at baseline, 6 and 12 weeks. Overall, no difference was found between groups for any of the research questions. Specifically, we were unable to demonstrate any difference between the active and sham device groups in frequency, nocturia, urinary leakage, or quality of life, nor was there any evidence of a placebo effect. The quality of the data was high with the number of missing observations (especially for disease specific KHQ and general AQOL) being few. This attempt to promote trans-sacral electromagnetic neuromodulation with a specially created device was ineffective on the symptoms of OAB.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1

Similar content being viewed by others

References

  1. Abrams P et al (2002) The standardisation of terminology of lower urinary tract function: report from the standardisation sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178

    Article  PubMed  Google Scholar 

  2. Milsom I, Abrams P, Cardozo L, Roberts RG, Thuroff J, Wein AJ (2001) How widespread are the symptoms of an overactive bladder and how are they managed? A population based prevalence study. Br J Urol Int 87:760–766

    CAS  Google Scholar 

  3. Stewart W, Herzog R, Wein AJ, et al (2001) Prevalence of overactive bladder in the US: results from the NOBLE program Poster presented at the WHO International Consultation on Incontinence, Paris, France (abstract)

  4. Kelleher CJ, Cardozo L, Khullar V, Salvatore S (1997) A medium-term analysis of the subjective efficacy of treatment of women with detrusor instability and low bladder compliance. BJOG 104(9):988–993

    Article  CAS  Google Scholar 

  5. Hassouna MM et al (2000) Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicentre study on efficacy and safety. J Urol 163(6):1849–1854

    Article  PubMed  CAS  Google Scholar 

  6. Weil EH et al (2000) Sacral root neuromodulation in the treatment of refractory urinary urge incontinence: a prospective randomised clinical trial. Eur Urol 37(2):161–171

    Article  PubMed  CAS  Google Scholar 

  7. McFarlane FP et al (1997) Acute suppression of idiopathic detrusor instability with magnetic stimulation of the sacral nerve roots. Br J Urol 80(5):734–741

    PubMed  CAS  Google Scholar 

  8. Yamanishi T et al (2000) Effect of functional continuous magnetic stimulation for urinary incontinence. J Urol 163:456–459

    Article  PubMed  CAS  Google Scholar 

  9. Goldberg RP, Sand PK (2001) Electromagnetic pelvic floor stimulation for urinary incontinence and bladder disease. Int Urogynecol J Pelvic Floor Dysfunct 12(6):401–404

    Article  PubMed  CAS  Google Scholar 

  10. Hawthorne G, Richardson J, Day N (1996) Technical Report 12: Using the assessment of Quality of Life (AQoL) Instrument—version 1.0. Melbourne, Centre for Health Program Evaluation, pp 1–77

  11. Stata v9 Edition (2005) College Station, Texas, Stata Corporation

  12. Holm-Bentzen M, Jacobsen F, Nerstrom B et al (1987) A prospective double blind clinically controlled multicenter trial of elmiron in the treatment of interstitial cystitis and related painful bladder diseases. J Urol 137:503–507

    Google Scholar 

  13. Takahashi S, Kitamura T (2003) Overactive bladder: magnetic versus electrical stimulation. Curr Opinion Obs Gynae 15:429–433

    Article  Google Scholar 

  14. Macfarlane JP, Foley SJ, DeWinter P et al (1997) Acute suppression of idiopathic detrusor instability with magnetic stimulation of the sacral roots. Br J Urol 80:734–741

    Google Scholar 

  15. Galloway NTM, El-Galley RES, Sans PK, Appell RA (1999) Extracorporeal magnetic innervation therapy for stress urinary incontinence. Urology 53:1108–1111

    Article  PubMed  CAS  Google Scholar 

  16. Yamanishi T, Sakakibara R, Uchiyama T et al (2000) Comparative study of the effects of magnetic versus electrical stimulation on inhibition of detrusor overactivity. Urology 56:777–781

    Article  PubMed  CAS  Google Scholar 

  17. Fujishiro T, Takahashi S, Enomoto H et al (2002) Magnetic stimulation of the sacral nerve roots for the treatment of urinary frequency and urge incontinence: an investigational study and placebo controlled trial. J Urol 168:1036–1039

    Article  PubMed  Google Scholar 

  18. Bradshaw HD, Barker AT, Radley SC, Chapple CR (2003) The acute effects of magnetic stimulation of the pelvic floor on involuntary detrusor activity during natural filling and overactive bladder symptoms. BJU Int 91:810–3

    Article  PubMed  CAS  Google Scholar 

  19. Yokoyama T, Fujita O, Nishiguchi J et al (2004) Extracorporeal magnetic innervation treatment for urinary incontinence. Int J Urol 11:602–6

    Article  PubMed  Google Scholar 

  20. Unsal A, Saglam R, Cimentepe E (2003) Extracorporeal magnetic stimulation for the treatment of stress and urge incontinence in women. Scand J Urol Nephrol 37:424–428

    Article  PubMed  Google Scholar 

  21. Almeida FG, Brsuschini H, Srougi M (2004) Urodynamic and clinical evaluation of 91 female patients with urinary incontinence treated with perineal magnetic stimulation: 1 year follow-up. J Urol 171:1571–1575

    Article  PubMed  Google Scholar 

  22. Fujishiro T, Takahashi S, Enomoto H et al (2002) Magnetic stimulation of sacral nerve roots for the treatment of urinary frequency and urge incontinence: an investigational study and placebo controlled trial. J Urol 168:1036–1039

    Article  PubMed  Google Scholar 

  23. But I (2003) Conservative treatment of female urinary incontinence with functional magnetic stimulation. Urology 61:558–561

    Article  PubMed  Google Scholar 

  24. Quek P (2005) A critical review on magnetic stimulation: what is its role in management of pelvic floor disorders. Curr Opin Urol 15(4):231–235

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Urogynaecology, Mercy Hospital for Women, Melbourne, Australia

    B. A. O’ Reilly, M. Fynes, C. Achtari, R. Hiscock, E. Thomas, C. Murray & P. L. Dwyer

  2. The Department of Gynaecology, Cork University Maternity Hospital, Cork, Ireland

    B. A. O’ Reilly

Authors
  1. B. A. O’ Reilly
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. M. Fynes
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. C. Achtari
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. R. Hiscock
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. E. Thomas
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. C. Murray
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. P. L. Dwyer
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to B. A. O’ Reilly.

Rights and permissions

Reprints and permissions

About this article

Cite this article

O’ Reilly, B.A., Fynes, M., Achtari, C. et al. A prospective randomised double-blind controlled trial evaluating the effect of trans-sacral magnetic stimulation in women with overactive bladder. Int Urogynecol J 19, 497–502 (2008). https://doi.org/10.1007/s00192-007-0481-y

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00192-007-0481-y

Keywords

Search

Navigation