Randomized, Sham-controlled Study on the Effectiveness of Magnetic Stimulation in the Treatment of Female Urgency Urinary Incontinence.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Incontinence
- Sponsor
- University Medical Centre Ljubljana
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Change in the ICIQ-UI SF score
- Status
- Completed
- Last Updated
- 7 months ago
Overview
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.
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.
Investigators
David Lukanovic
asist. dr.
University Medical Centre Ljubljana
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in the ICIQ-UI SF score
Time Frame: 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 2
Time Frame: 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 urodynamic studies 1
Time Frame: 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 voiding diary 1
Time Frame: 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 3
Time Frame: 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 2
Time Frame: Before the treatment and 3 months after the treatment.
Difference in the maximum cystometric capacity. Higher volume means better outcome.
Secondary Outcomes
- 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.)
- 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.)
- 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.)
- 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.)