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

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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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Acknowledgements

We would like to thank all the study participants.

Author information

Authors and Affiliations

  1. School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800, Penang, Malaysia

    Renly Lim, Nurzalina Abdul Karim Khan & Kah Hay Yuen

  2. School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia

    Renly Lim

  3. Department of Urology, Island Hospital, Penang, Malaysia

    Men Long Liong

  4. Department of Urology, Lam Wah Ee Hospital, Penang, Malaysia

    Wing Seng Leong

Authors
  1. Renly Lim
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  2. Men Long Liong
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  3. Wing Seng Leong
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  4. Nurzalina Abdul Karim Khan
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  5. Kah Hay Yuen
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Corresponding author

Correspondence to Renly Lim.

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Funding

The study was funded by QRS International, Liechtenstein.

Ethics committee

The study was approved by the Joint Ethics Committee of the School of Pharmaceutical Sciences, USM-HLWE on Clinical Studies (USM-HLWE/IEC/2013[0006]).

Conflicts of interest

Renly Lim was a PhD student who received a research allowance from QRS International (sponsor of the clinical trial) during her PhD candidature. All other authors declare that they have no competing interests.

Electronic supplementary material

Supplement 1

First phase: 120 subjects were randomized to either active (n = 60) or sham (n = 60) PMS for 2 months. Second phase: after 2 months, subjects could opt for 16 additional active PMS sessions (open-label phase). Third phase: subjects returned for follow-up at months 5, 8, and 14. (GIF 12 kb)

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Lim, R., Liong, M.L., Leong, W.S. et al. Effect of pulsed magnetic stimulation on quality of life of female patients with stress urinary incontinence: an IDEAL-D stage 2b study. Int Urogynecol J 29, 547–554 (2018). https://doi.org/10.1007/s00192-017-3439-8

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  • DOI: https://doi.org/10.1007/s00192-017-3439-8

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