Effectiveness of Magnetic Stimulation in the Treatment of Female UUI.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active group 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
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.
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| Sham Comparator: Sham group 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
The same chair as is used in the active group with the magnetic field density at the lower 2% resulting in negligible efficacy.
|
Outcome Measures
Primary Outcome Measures
- Change in the ICIQ-UI SF score [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
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.
- Change in voiding diary 1 [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
Difference in the mean voided volume. Higher mean voided volume means better outcome.
- Change in voiding diary 2 [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
Difference in the mean number of incontinence episodes. Lower number of incontinence episodes means better outcome.
- Change in voiding diary 3 [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
Difference in the mean number of micturitions. Lower number of micturitions means better outcome.
- Change in urodynamic studies 1 [Before the treatment and 3 months after the treatment.]
Difference in the volume at first desire to void. Higher volume means better outcome.
- Change in urodynamic studies 2 [Before the treatment and 3 months after the treatment.]
Difference in the maximum cystometric capacity. Higher volume means better outcome.
Secondary Outcome Measures
- Change in UDI-6 score [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
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.
- Change in IIQ-7 score [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
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.
- Change in PISQ-12 score [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
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.
- Change in King's Health questionnaire [Before the treatment and immediately after the treatment, 3 months after the treatment, 6 months after the treatment and 12 months after the treatment.]
Difference in the score of the King's health questionnaire. Scores go from 0 to 100. With lower score meaning better outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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urgency urinary incontinence proved by urodynamic studies
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18 years of age
Exclusion Criteria:
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pregnancy
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cystitis or other active infections
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stress or mixed urinary incontinence
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prolapse of pelvic organs with POP-Q score greated than 2
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fecal incontinence
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severe medical conditions (e.g. active treatment of cancer)
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connective tissue disease
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neurologic disease
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Gynecology, Division of Gynecology and Obstetrics, Ljubljana University Medical Center | Ljubljana | Slovenia | 1000 |
Sponsors and Collaborators
- University Medical Centre Ljubljana
- University of Ljubljana, Faculty of Medicine
Investigators
- Principal Investigator: Adolf Lukanović, MD, PhD, Department of Gynecology, Division of Gynecology and Obstetrics, Ljubljana University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
- He Q, Xiao K, Peng L, Lai J, Li H, Luo D, Wang K. An Effective Meta-analysis of Magnetic Stimulation Therapy for Urinary Incontinence. Sci Rep. 2019 Jun 24;9(1):9077. doi: 10.1038/s41598-019-45330-9.
- Lukanovic D, Kunic T, Batkoska M, Matjasic M, Barbic M. Effectiveness of Magnetic Stimulation in the Treatment of Urinary Incontinence: A Systematic Review and Results of Our Study. J Clin Med. 2021 Nov 8;10(21):5210. doi: 10.3390/jcm10215210.
- Yamanishi T, Homma Y, Nishizawa O, Yasuda K, Yokoyama O; SMN-X Study Group. Multicenter, randomized, sham-controlled study on the efficacy of magnetic stimulation for women with urgency urinary incontinence. Int J Urol. 2014 Apr;21(4):395-400. doi: 10.1111/iju.12289. Epub 2013 Oct 14.
- UMCL-UUI