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.
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We thank all study participants.
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Funding
This study was partially funded by QRS International.
Conflicts of interest
RL was a full-time doctoral student at Universiti Sains Malaysia who received a research assistant allowance from QRS International during the study period. All other authors declare that they have no conflict of interest.
Ethical 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]).
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Lim, R., Liong, M.L., Leong, W.S. et al. Patients’ perception and satisfaction with pulsed magnetic stimulation for treatment of female stress urinary incontinence. Int Urogynecol J 29, 997–1004 (2018). https://doi.org/10.1007/s00192-017-3425-1
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DOI: https://doi.org/10.1007/s00192-017-3425-1