Effectiveness of Magnetic Stimulation in the Treatment of Female UUI.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Urinary Incontinence, Urinary Incontinence, Urge, Pelvic Floor Disorders

Intervention / Treatment
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* Device: Extracorporeal magnetic stimulation
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: urgency urinary incontinence proved by urodynamic studies 18 years of age Exclusion Criteria: pregnancy cystitis or other active infections stress or mixed urinary incontinence prolapse of pelvic organs with POP-Q score greated than 2 fecal incontinence severe medical conditions (e.g. active treatment of cancer) connective tissue disease neurologic disease

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active group<br>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. | Device: Extracorporeal magnetic stimulation<br>* Extracorporeal magnetic stimulation is a technique based on Faraday's law of magnetic induction, approved by the United States Food and Drug Administration in 1998, for conservative treatment of urinary incontinence. It generates electrical activity, which induces controlled depolarization of the nerves, resulting in pelvic muscle contraction and sacral S2-S4 roots neuromodulation. The patient seats in the chair fully clothed.<br>|
| Sham Comparator: Sham group<br>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. | Other: Sham<br>* The same chair as is used in the active group with the magnetic field density at the lower 2% resulting in negligible efficacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ICIQ-UI SF score | 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. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 
| Change in voiding diary 1 | Difference in the mean voided volume. Higher mean voided volume means better outcome. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 
| Change in voiding diary 2 | Difference in the mean number of incontinence episodes. Lower number of incontinence episodes means better outcome. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 
| Change in voiding diary 3 | Difference in the mean number of micturitions. Lower number of micturitions means better outcome. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 
| Change in urodynamic studies 1 | Difference in the volume at first desire to void. Higher volume means better outcome. | Before the treatment and 3 months after the treatment. | 
| Change in urodynamic studies 2 | Difference in the maximum cystometric capacity. Higher volume means better outcome. | Before the treatment and 3 months after the treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UDI-6 score | 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. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 
| Change in IIQ-7 score | 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. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 
| Change in PISQ-12 score | 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. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 
| Change in King's Health questionnaire | Difference in the score of the King's health questionnaire. Scores go from 0 to 100. With lower score meaning better outcome. | Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary urgency, urgency urinary incontinence, urinary incontinence, magnetic stimulation