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Introduction and Hypothesis <p>Magnetic stimulation is a noninvasive, painless neuromodulatory therapy that has emerged as a promising conservative treatment for urinary incontinence. This study aimed to evaluate its clinical effectiveness and safety in women with urgency urinary incontinence (UUI).</p> Methods <p>In this single-centre, prospective randomised controlled trial, 70 women with UUI were randomised in a 2:1 ratio to active MS or sham treatment. Participants received 12 sessions of magnetic stimulation over 6 weeks. The active group received individually adjusted stimulation intensity, while the sham group received minimal stimulation to preserve blinding. The primary outcome was change in symptom severity measured by the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). Secondary outcomes included bladder diary parameters (urinary frequency, urgency urinary incontinence episodes, nocturia), symptom-specific quality of life (UDI-6, IIQ-7), and patient-reported improvement (PGI-I). Outcomes were assessed at baseline and 6 months post-treatment.</p> Results <p>At 6 months, 40 participants in the active group and 16 in the sham group completed follow-up. The active group demonstrated significantly greater improvement in ICIQ-UI SF scores (mean change −4.05 ± 3.23) compared to sham (−1.19 ± 1.72; <i>p</i> &lt; 0.001). Significant improvements were also observed in urgency incontinence episodes, nocturia, and quality of life measures in the active group. No serious adverse events were reported, confirming the favourable safety profile of MS.</p> Conclusions <p>This study provides new controlled evidence supporting MS as an effective, noninvasive, and well-tolerated treatment for women with UUI. These findings contribute important data on mid-term efficacy but highlight the need for further high-quality RCTs with standardised protocols and longer-term follow-up.</p>

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Magnetic Stimulation in the Treatment of Urgency Urinary Incontinence: A Randomized Sham-Controlled Clinical Trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月16日

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  • David Lukanović,
  • Anja Antič,
  • Maja Pavčnik,
  • Matija Barbič,
  • Miha Matjašič,
  • Adolf Lukanović

摘要

Introduction and Hypothesis

Magnetic stimulation is a noninvasive, painless neuromodulatory therapy that has emerged as a promising conservative treatment for urinary incontinence. This study aimed to evaluate its clinical effectiveness and safety in women with urgency urinary incontinence (UUI).

Methods

In this single-centre, prospective randomised controlled trial, 70 women with UUI were randomised in a 2:1 ratio to active MS or sham treatment. Participants received 12 sessions of magnetic stimulation over 6 weeks. The active group received individually adjusted stimulation intensity, while the sham group received minimal stimulation to preserve blinding. The primary outcome was change in symptom severity measured by the International Consultation on Incontinence Questionnaire–Urinary Incontinence Short Form (ICIQ-UI SF). Secondary outcomes included bladder diary parameters (urinary frequency, urgency urinary incontinence episodes, nocturia), symptom-specific quality of life (UDI-6, IIQ-7), and patient-reported improvement (PGI-I). Outcomes were assessed at baseline and 6 months post-treatment.

Results

At 6 months, 40 participants in the active group and 16 in the sham group completed follow-up. The active group demonstrated significantly greater improvement in ICIQ-UI SF scores (mean change −4.05 ± 3.23) compared to sham (−1.19 ± 1.72; p < 0.001). Significant improvements were also observed in urgency incontinence episodes, nocturia, and quality of life measures in the active group. No serious adverse events were reported, confirming the favourable safety profile of MS.

Conclusions

This study provides new controlled evidence supporting MS as an effective, noninvasive, and well-tolerated treatment for women with UUI. These findings contribute important data on mid-term efficacy but highlight the need for further high-quality RCTs with standardised protocols and longer-term follow-up.