Randomized, Sham-controlled Study on the Effectiveness of Magnetic Stimulation in the Treatment of Female Urgency Urinary Incontinence.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in voiding diary 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •urgency urinary incontinence proved by urodynamic studies
- •18 years of age
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Extracorporeal magnetic stimulation (Device)
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.
干预措施: Sham (Other)
结局指标
主要结局
Change in voiding diary 3
时间窗: 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
时间窗: Before the treatment and 3 months after the treatment.
Difference in the maximum cystometric capacity. Higher volume means better outcome.
Change in the ICIQ-UI SF score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
David Lukanovic
asist. dr.
University Medical Centre Ljubljana