Urinary incontinence is becoming an increasingly common health, social and economic problem.
      The prevalence of urinary incontinence is estimated at 55% of the entire female population.
      Urgency urinary incontinence (UUI) is the least common subtype of urinary incontinence but
      has debilitating symptoms that lead to a decrease in quality of life. Ultimately, the
      urogynegology field does not have many successful types of treatments for this specific
      subtype. Extracorporeal magnetic stimulation of the pelvic floor is a type of conservative
      management that produces a magnetic field, which induces controlled depolarization of the
      nerves, resulting in pelvic muscle contraction and sacral S2-S4 roots neuromodulation.
      Therefore, it relieves symptoms of UUI and improves quality of life.

      There was no randomized, sham-controlled study published that researched the effectiveness of
      magnetic stimulation in the treatment of UUI that evaluated the success with subjective and
      objective methods, such as urodynamic studies.

      The aim of this study was to assess the efficacy of magnetic stimulation in the treatment of
      urgency urinary incontinence.

Effectiveness of Magnetic Stimulation in the Treatment of Female UUI.

Urinary Incontinence

Urinary Incontinence, Urge

Pelvic Floor Disorders

RATIONALE: The FDA approved extracorporeal magnetic stimulation as a form of conservative
      treatment of urinary incontinence in 1998. Since then, the studies focused mainly on magnetic
      stimulation's effectiveness in treating stress urinary incontinence. There are five studies
      that assessed the efficacy of magnetic stimulation in the treatment of urgency urinary
      incontinence. Only one was randomized and sham-controlled, others were not. Three studies
      used urodynamic studies to assess the effectiveness of magnetic stimulation treatment, but
      those studies were not randomized or sham-controlled. The EAU guidelines, therefore, do not
      recommend extracorporeal magnetic stimulation as a treatment option for urinary incontinence
      for the lack of evidence.

      AIM OF THE STUDY: The study will evaluate the efficacy of magnetic stimulation as a type of
      conservative treatment in patients with urgency urinary incontinence. After evaluating
      previously conducted studies, the investigators decided to conduct the first randomized,
      sham-controlled study that evaluated the effectiveness of magnetic stimulation as a treatment
      for urgency urinary incontinence with subjective and objective measures.

      METHODS: the study will be randomized and sham controlled with 40 enrolled patients. The
      patients will be allocated in the active or sham arm in a ratio of 2:1. The patients will be
      recruited from the UMC Ljubljana outpatient urogynecologic clinic. All eligible patients will
      be invited to participate in our study by phone.

      STATISTICAL ANALYSES: The results will be analysed with the Kolmogorov-Smirnov test and
      two-way ANOVA with repeated measures.

Extracorporeal magnetic stimulation

Sham

Randomized, Sham-controlled Study on the Effectiveness of Magnetic Stimulation in the Treatment of Female Urgency Urinary Incontinence.

Difference in the score of the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) questionnaire. The scoring scale is 0-21 points. Lower score means better outcome.

Difference in the mean voided volume. Higher mean voided volume means better outcome.

Difference in the mean number of incontinence episodes. Lower number of incontinence episodes means better outcome.

Difference in the mean number of micturitions. Lower number of micturitions means better outcome.

Difference in the volume at first desire to void. Higher volume means better outcome.

Difference in the maximum cystometric capacity. Higher volume means better outcome.

Difference in the score of the Urinary Distress Inventory Short Form (UDI-6) questionnaire. Score values go from 0 to 100. Lower score means better outcome.

Difference in the score of the Incontinence Impact questionnaire Short Form (IIQ-7) questionnaire. Scores go from 0 to 100 with lower score meaning better outcome.

Difference in the score of The Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Scores go from 0 to 48 with higher score meaning better outcome.

Difference in the score of the King's health questionnaire. Scores go from 0 to 100. With lower score meaning better outcome.

We are using an extracorporeal magnetic stimulation chair with two magnetic stimulators, one under the seat and one in the backrest, that generate the magnetic field. The treatment lasts for 30 minutes and has 5 steps. Each step has a defined duration and a defined frequency of magnetic field pulsations. In each step, it is also defined, which of the magnetic field generators are working. The pulsations last for 6 seconds followed by 6 seconds of rest.
Step 1: 10Hz, 7 minutes, 6 seconds on, 6 seconds off, both stimulators generate the magnetic field. Step 2: 10Hz, 4 minutes, the stimulator under the seat generates the magnetic field. Step 3: 10Hz, 7 minutes, the stimulator in the backrest generates the magnetic field. Step 4: 30Hz, 10 minutes, both stimulators generate the magnetic field. Step 5: After 5 minutes, both stimulators generate the magnetic field.
During the treatment, we adjusted the magnetic field density. It varied from 2-100%. The maximum was 3 Teslas.

We are using extracorporeal magnetic stimulation, a chair with two magnetic stimulators, one under the seat and one in the backrest, that generate the magnetic field. The treatment lasts for 30 minutes and has 5 steps. We used the same program as in the active group with the difference that the magnetic field density was always at 2% so the effects of the pulsating are negligible.

Effectiveness of Magnetic Stimulation in the Treatment of Female UUI.

About this trial

Study ID

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Type

Phase

Placebo

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Trial Timing

What is this trial about?

What are the participation requirements?

Locations

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