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2023年4月12日 星期三

The application of High-Intensity Focused Electromagnetic Field (HIFEM) in the treatment of urinary incontinence

 

When we introduced the treatment principle of high-intensity focused electromagnetic field before, we learned that it can not only train muscles but also promote the repair of various connective tissues. 

(https://uroprolo.blogspot.com/2023/03/mechanism-and-application-of-high.html)

This time, we will further explore what kind of therapeutic effect will happen if it is applied to the treatment of urinary incontinence.

 


Below are some representative studies.


 

Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life

https://pubmed.ncbi.nlm.nih.gov/31172580/

This study enrolled 75 patients with three types of urinary incontinence (mean age 55.45 years) who had not received any prior urinary incontinence treatment. 

The treatment involved high-intensity focused electromagnetic field therapy twice a week for a total of six treatments. 

The treatment effectiveness was evaluated by the absorbent pads used per day and the ICIQ-SF questionnaire.

 

Results:

61 patients (81%) experienced a significant reduction in urinary incontinence symptoms after six treatments. There was a significant improvement in quality of life (ICIQ-SF improvement of 49.93%). 

The treatment effect was maintained after a 3-month follow-up period (ICIQ-SF improvement of 64.42%). 

The most significant improvement was observed in patients with mixed urinary incontinence (ICIQ-SF improvement of 69.9%). 

70% of patients reported decreased number of used pads.

 

After reading this study, my impression is that if we the treatment effect is so excellent with HIFEM one course only, then the effect can be further enhanced by combining it with mediation and increasing the courses of treatments.

Additionally, it can be observed that even after a 3-month follow-up period, the treatment effect not only persisted but also continued to improve (Note 1). 

This suggests that HIFEM does not simply train the muscles (as stopping training would result in either maintenance or regression), but also has a therapeutic effect on tissue repair, leading to sustained improvement even after treatment cessation.

 

Furthermore, based on past treatment experience and research, self-training of the pelvic floor muscles cannot guarantee the quality and duration of the training. 

Patients who wish to achieve therapeutic effects through self-training of the pelvic floor muscle group typically require 12 to 40 weeks of training. 

In contrast, HIFEM equipment ensures the quality of each treatment, and the treatment effect was observed within just 3 weeks. The therapeutic benefits of this treatment are evident.

 

The previous study results inferred that HIFEM has a repairing effect on pelvic floor tissues. So, is there more direct evidence? 

 

Yes, there is.

 

A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data

https://pubmed.ncbi.nlm.nih.gov/31860567/

This study enrolled 95 parous women, divided into three groups:

1.    Group 1: 50 urinary incontinence patients receiving 10 sessions of high-intensity focused electromagnetic (HIFEM) therapy (n = 50, HIFEM)

2.    Group 2: 25 urinary incontinence patients receiving electrical stimulation therapy (n = 25, electrical stimulation)

3.    Group 3: 20 healthy subjects as a control group (no treatment) (n = 20, control group)

Patients underwent examination by 3-dimensional transperienal ultrasound at the baseline and posttreatments. 

Levator-urethra gap, anteroposterior diameter, laterolateral diameter of levator hiatus, and hiatal area were measured. 

They also completed the Pelvic Floor Disability Index 20 questionnaire and subjective evaluation of intimate health.

 

Results: 

Only Group 1 patients showed significant improvement on ultrasound examination after treatment (decreased anteroposterior diameter, laterolateral diameter, and hiatal area). 


Group 1 patients achieved greater improvement in the Pelvic Floor Disability Index questionnaire compared to Group 2 (52% vs. 18%; P < 0.001), and there was a significant reduction in patients with urinary leakage after treatment.

 

My personal impression is that most studies on urinary incontinence focus on subjective questionnaire surveys, with pad usage as a secondary objective (also often assessed by questionnaire). 

This study is one of the few urinary incontinence treatment-related studies that evaluate treatment effects based on both subjective (questionnaire survey) and objective examination (3D transperineal ultrasound) methods.

 

Furthermore, not only tissue repair but also muscle contractility can be objectively confirmed (by electromyography), proving the effectiveness on the pelvic floor muscles training.

https://pubmed.ncbi.nlm.nih.gov/32146133/

 

 

Final question.

How long does the effect of high-intensity electromagneticfield therapy last? 

Currently, there is a lack of studies with longer follow-up. 

According to studies from traditional magnetic stimulation machines (Note 2), even after one year, the therapeutic effect can still be maintained. 

Moreover, the more treatment sessions, the better the effect.

https://pubmed.ncbi.nlm.nih.gov/27871927/

https://pubmed.ncbi.nlm.nih.gov/28791447/

 

 

Summay:

High-intensity focused electromagnetic field treatment of urinary incontinence has the following advantages

1. Non-invasive (better than surgery)

2. No side effects (better than drugs)

3. The curative effect is fast and effective (better than self-training and traditional magnetic stimulation chair)

4. Helps tissue repair, long-lasting effect (better than other treatment methods like electrotherapy, surgery, drugs)

5. Improves quality of life

 

Certainly, this does not mean that other treatment modalities should be discarded.

Every treatment has a role.

Clinically, different treatment methods are often combined at the same time to achieve the best therapeutic effect.

Therefore, patients with urinary incontinence problems should still seek professional medical assistance to receive appropriate treatment recommendations and prescriptions.

 

 

#Emsella

#SIS(super inductive system)

 

Other references:

https://pubmed.ncbi.nlm.nih.gov/34768730/

https://pubmed.ncbi.nlm.nih.gov/35447699/

 

(Note 1: The average ICIQ-SF score of the patients was 10.57 ± 4.22, which decreased to 5.33 ± 3.97 after six treatments, and further decreased to 4.16 ± 4.04 points in the 3-month follow-up. After six treatments, 13 patients had ICIQ -SF score decreased to 0 points, and the number of patients who decreased to 0 points after 3 months of follow-up increased to 21.

 

At the beginning of the study, 43 patients used one or more pads per day, with an average of 2.47 ± 2.25 pads per day. After the sixth treatment, a significant improvement of 43.80% (P < 0.001) was observed, with the average number of pads used reduced to 1.35 ± 1.74 per day.

Fifteen (34.88%) of these patients reported that they no longer used the pads, and at 3 months, this had increased to 19 (44.19%) patients. )

 

(Note 2:

Magnetic stimulation has been used to treat urinary incontinence for many years.

There are also machine models and treatments covered by National Health Insurance in Taiwan.

However. the magnetic field strength generated by the instrument is much weaker than HIFEM and lacks focusing technology. 

The difference can be clearly felt when receiving treatment.)

高強度聚焦式磁場在尿失禁治療的應用


之前介紹高強度聚焦式磁場的治療原理時

(https://uroprolo.blogspot.com/2023/03/hifem-high-intensity-focused.html)

我們了解到

它不但能訓練肌肉

亦能促進各種結締組織的修復

這次要進一步探討

這樣的效果若應用在尿失禁治療上

會有怎樣的療效

 

以下擷取一些具有代表性的研究

 

Safety and Efficacy of a Non-Invasive High-Intensity Focused Electromagnetic Field (HIFEM) Device for Treatment of Urinary Incontinence and Enhancement of Quality of Life

非侵入性高強度聚焦式磁場(HIFEM)設備治療尿失禁和提高生活質量的安全性和有效性

https://pubmed.ncbi.nlm.nih.gov/31172580/

此篇研究收集共75位罹患包含三種類型尿失禁之患者(平均年齡55.45歲)

且之前並未接受任何尿失禁治療

治療方式為高強度聚焦式磁場每周治療2次,總共6次治療

並以每日使用之衛生墊數量及ICIQ‐SF 問卷評估治療效果

 

研究結果:

61位(81%)患者在六次治療後尿失禁症狀明顯減輕

生活品質有顯著改善 (ICIQ‐SF 改善49.93%)。

追蹤3個月仍可維持其效果 (ICIQ‐SF 改善64.42%) 。

混合性尿失禁患者改善最顯著 (ICIQ‐SF 改善69.9%)。

70%的患者可減少每日使用之衛生墊數量。

 

我自己看完這篇研究的感想是

只單獨使用高強度磁場治療

且只做了一個療程

效果已經如此優異

若搭配傳統藥物治療、增加治療次數,效果定可更加提昇!

另外細看研究結果可發現    

即使在停止治療後三個月的追蹤

療效不但能維持且有持續進步的現象(註一)

可推測高強度磁場不單單只是訓練肌肉(因為若停止訓練頂多維持原狀或衰退)

其促進組織修復的療效使的病患即使停止治療仍有持續性的進步

 

另外根據以往的治療經驗及研究

自行訓練骨盆底肌無法確保訓練的品質及時間

且病患若想經由自行訓練骨盆底肌群達到治療效果

根據統計需要的時間約為12週至40週

而透過高強度磁場治療儀器不僅確保每次治療的品質

且這個研究完成一輪治療不過3週的時間即可看出療效

其治療效益不言而喻

 

 

剛剛的研究是由結果「推論」高強度磁場對骨盆底組織有修復效應

那麼

有沒有較直接的證據呢?

 

有的

 

A Comparative Study on the Effects of High-Intensity Focused Electromagnetic Technology and Electrostimulation for the Treatment of Pelvic Floor Muscles and Urinary Incontinence in Parous Women: Analysis of Posttreatment Data

高強度聚焦式磁場和電刺激治療產後婦女骨盆底肌肉和尿失禁效果的比較研究:治療後數據分析

https://pubmed.ncbi.nlm.nih.gov/31860567/

本研究納入95名受試者並分為以下三組:

第一組50名尿失禁患者接受高強度聚焦式磁場治療10次(n = 50,HIFEM)

第二組25名尿失禁患者接受電刺激治療(n = 25,電刺激)

第三組20名健康受試者僅做為對照組(沒有接受任何治療)(n = 20,對照組)

受試者在治療前後會接受3D經會陰超音波(3-dimensional transperineal ultrasound)測量提肌-尿道間隙、提肌(生殖)裂孔的前後徑、兩側直徑和裂孔面積

並接受骨盆底功能障礙指數問卷評估(Pelvic Floor Disability Index 20 questionnaire)和及私密健康的主觀評價。


結果:

僅第一組患者在治療後超音波檢查發現有顯著改善(提肌(生殖)裂孔前後徑、兩側直徑及裂孔面積減小)


第一組患者在骨盆底功能障礙指數問卷中比第二組取得了更大程度的改善(分別為 52% 和 18%; P < 0.001)

且治療後有漏尿的患者明顯減少。

 

我自己的感想是

大部份尿失禁的研究多以主觀問卷調查為主

客觀則以護墊使用數量為輔(但亦多為問卷調查)

這篇研究是尿失禁治療相關研究中

極少數能同時基於主觀(問卷調查)和客觀檢查(3D 經會陰超音波)方法來評估治療效果

 

另外不只是組織修復

肌肉收縮力亦可用客觀的肌電圖檢查得到佐證

證實高強度磁場對骨盆底肌群的訓練成效

https://pubmed.ncbi.nlm.nih.gov/32146133/

 

 

最後的問題

高強度磁場治療的效果能持續多久呢?

目前文獻尚缺乏較長追蹤時間的報告

若根據舊式磁波儀的研究(註二)

即使經過一年、療效仍能維持

並且治療次數越多

效果越好

https://pubmed.ncbi.nlm.nih.gov/27871927/

https://pubmed.ncbi.nlm.nih.gov/28791447/

 

 

總結:

高強度聚焦式磁場治療尿失禁具有以下優點

1.非侵入性(優於手術)

2.無副作用(優於藥物)

3.療效快速且有效(優於自主訓練、傳統磁波椅)

4.幫助組織修復、療效持久(優於電療、手術、藥物等其他治療方式)

5.提昇生活品質

 

當然

這並不意味著其他治療方式就該被摒棄

各種治療皆有其角色

臨床上亦常同時合併不同治療方式以達到最好的治療效果

因此

有尿失禁困擾的患者

仍該尋求專業醫師的協助

給予適當治療建議及處方

 


#高強度聚焦式磁場治療儀

#Emsella

#G動椅

 

其他參考資料:

https://pubmed.ncbi.nlm.nih.gov/34768730/

https://pubmed.ncbi.nlm.nih.gov/35447699/

 

 

(註一:患者平均 ICIQ-SF 分數為 10.57 ± 4.22,六次治療後下降至 5.33 ± 3.97,並在3個月的追蹤中進一步降低至 4.16 ± 4.04 分。六次治療後有13名患者 ICIQ-SF 分數降為0分,3個月後追蹤、降為0分的患者增加至21名。

 

研究開始時,有43 名患者每天使用一個或多個護墊,平均每天使用護墊數2.47±2.25。第六次治療後,觀察到 43.80% (P < 0.001) 的顯著改善,平均使用的護墊數減少到每天1.35 ± 1.74。

其中15 名 (34.88%) 患者報告他們不再使用護墊,並且在3 個月時,增加到 19 名 (44.19%) 患者。)

 

(註二:

磁場刺激(magnetic stimulation)治療尿失禁已行之有年

亦有健保給付的機型與治療

然而

健保磁波儀產生的磁場強度弱很多

亦無聚焦技術

接受治療時可明顯感受到其差異性)