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作者：Fran Lowry  
出處：WebMD醫學新聞

　　September 28, 2009 (佛羅里達好萊塢) — 對於短期壓力型尿失禁(SUI)的治療，行為治療使得令人困擾的失禁症狀減少，且病患滿意度增加，優於控制型子宮托(continence pessary)。不過，在較久的追蹤期之後，這些差異並不存在。再者，併用這兩種治療方式並未優於單一種方法。
　　
　　阿拉巴馬大學的Holly E. Richter博士在美國婦女泌尿科協會第30屆年度科學會議中表示，這是首次以隨機控制試驗比較這些SUI的非手術治療方式，研究結果提供了實證基礎的資料，可以用於病患諮商。
　　
　　Richter博士表示，專家控制團體建議，和病患討論與教育現有的非手術治療選項且提供給病患。行為治療是有效的，但是婦女必須有動機遵守治療，而且也不是每個醫師診間都有獲得認證的行為治療師。控制型子宮托是一種替代方式，已經用於壓力型尿失禁治療數十年。令人驚訝的是，沒有隨機試驗比較子宮托和有實證基礎的行為治療。
　　
　　因此，Richter博士和來自骨盆腔底異常症網絡的研究夥伴，隨機將446名SUI女性分派接受行為治療、控制型子宮托、或併用這兩種方式。這些研究對象來自美國的10處臨床機構。
　　
　　行為治療是由行為治療師以每兩週的間隔進行四次訪視；使用子宮托者則由護士或醫師以最多三次的診視確認有適當放置。
　　
　　主要結果是採取病患整體改善印象評量表(PGI-I)之評分，成功的定義為很好或相當好，另外也採用骨盆腔底壓力量表(PFDI)的壓力型尿失禁次量表。採用治療意向分析。主要結果時間點為三個月時的量測。
　　
　　研究者也對那些在隨機分組之後，持續進行指定之治療方式12個月者，進行次級的完成計劃書療程分析法。
　　
　　三組的病患都相似。平均年紀為50歲、85%是白人、46%為單純壓力型尿失禁、54%同時有壓力型和急迫型尿失禁、21%曾經嚐試某種的非手術治療、6%接受過失禁手術。
　　
　　三個月時，47%研究對象的PGI-I測量報告為很好或相當好。併用組的改善比率為53.3%、行為治療組為49.3%、子宮托組為39.6%。行為治療組和子宮托組的PGI-I結果沒有差異(P=.10)。
　　
　　PFDI 測量的壓力型尿失禁次量表中，三個月時，行為組的壓力症狀和滿意度顯著優於子宮托組(49% vs 33%；P<.01)。不過，到了12個月時，兩組之間並沒有差異(54.1% vs 50.3%；P= –.53)。
　　
　　在任何時間點的任何結果，併用治療並未優於任一種方式。因此，不建議一開始就採取併用治療。
　　
　　Richter博士在Medscape Ob/Gyn Women's Health的訪問中表示，研究結果將改變醫師和病患的諮商，因為現在更多有關於這兩種治療方式結果的資料。基本上，我們一直試著從事實證醫學，但是我們並沒有任何有關使用子宮托的資料可以在與婦女諮商時引用。我們有等級1的行為治療資料，但有關子宮托的全都沒有。
　　
　　她指出，我們在實務上使用子宮托和行為治療時，有些婦女會被這些方法之一種或另一種吸引。雖然在三個月時，行為治療看來似乎優於子宮托，但是，長久看來，喜歡子宮托的婦女依舊可以從中獲得治療利益。我們希望瞭解婦女的偏好變項或因素，以預測使用子宮托或行為治療可以成功。不過，如同任何的治療方式，個人的照護仍然相當重要。
　　
　　Richter博士發表之後，加州大學爾灣分校的Karen Noblett醫師接受Medscape Ob/Gyn Women's Health的訪問時表示，我認為這是極佳的研究，很少有研究探究壓力型尿失禁的非手術治療。有了這兩種分手術方式的確認比較資料，且探討併用效果，讓我們有了相關證據證明兩種都有效。
　　
　　維吉尼亞大學的Elisa Trowbridge醫師指出，她聽到行為治療有幫助時相當激動，但是也承認她熱愛使用子宮托。
　　
　　她表示，子宮托對於那些有共病症的婦女特別有用，這方法在某些病患的確有效。這些婦女有其他醫療問題，只不過凱格爾氏運動不適合她們；她們有心衰竭、動作問題；忘記每週找治療師；所以控制型子宮托仍然是一些失能病患的良好選項。
　　
　　她指出，減重也是SUI的極佳治療。我希望有研究提及此點。
　　
　　Eunice Kennedy Shriver兒童健康與人類發展研究中心、國家糖尿病與消化道與腎臟疾病研究中心、以及國家健康研究中心婦女健康研究辦公室、國家健康研究中心等支持本研究。Richter博士、Noblett醫師與Trowbridge醫師皆宣告沒有相關財務關係。
　　
　　美國婦女泌尿科協會(AUGS)第30屆年度科學會議：報告1。發表於2009年9月24日。

First RCT Shows Similar Efficacy Among Nonsurgical Treatments for Stress Urinary Incontinence

By Fran Lowry
Medscape Medical News

September 28, 2009 (Hollywood, Florida) — Behavioral therapy resulted in fewer bothersome incontinence symptoms and greater patient satisfaction than a continence pessary for the treatment of stress urinary incontinence (SUI) in the short term. However, these differences did not persist with longer follow-up. Moreover, combining the 2 treatments was not superior to single-modality therapy.

The results, from the first randomized controlled trial (RCT) to compare these nonsurgical treatments for SUI, provide evidence-based data that can now be used to counsel patients, Holly E. Richter, PhD, MD, from the University of Alabama at Birmingham, said at the American Urogynecologic Society 30th Annual Scientific Meeting.

"Expert consensus groups have recommended that we discuss and educate patients about the nonsurgical treatment options that are available and offer them to our patients," Dr. Richter said. "Behavioral therapy is effective, but women have to be motivated to adhere to the therapy, and there might not be certified behavioral therapists in every clinician's office. Continence pessaries are an alternative that we've all used in the treatment of stress incontinence for decades. Surprisingly, there are no randomized trials comparing pessaries with evidence-based behavioral therapy."

To address this void, Dr. Richter and her colleagues from the Pelvic Floor Disorders Network randomized 446 women with SUI to receive behavioral therapy, continence pessary, or both treatments combined. The women were recruited from 10 clinical sites across the United States.

Behavioral therapy was administered in 4 visits at 2-week intervals by certified behavioral therapists. The pessaries were fitted by nurses or physicians in up to 3 clinic visits to ensure optimum fitting.

Primary outcomes assessed were the Patient Global Impression of Improvement (PGI-I) scale, where success was defined as "much" or "very much better," and the stress incontinence subscale of the Pelvic Floor Distress Inventory (PFDI). The analysis was intention to treat. The primary outcome timepoint was determined at 3 months.

The investigators also performed a secondary per-protocol analysis in subjects who persisted with their assigned therapy 12 months after randomization.

The patients were similar in all 3 groups. The mean age was 50 years, 85% were white, 46% had stress only incontinence, 54% had a mix of stress and urge incontinence, 21% had tried some type of nonsurgical therapy in the past, and 6% had undergone surgery for incontinence.

At 3 months, 47% of participants reported on the PGI-I measure that they were "much better" or "very much better." Rates of improvement were 53.3% for the combination group, 49.3% for the behavioral group, and 39.6% for the pessary group. The PGI-I outcomes did not differ between the behavioral and pessary groups (P?=.10).

On the stress incontinence subscale of the PFDI measure, stress symptoms and satisfaction were significantly better in the behavioral group than in the pessary group at 3 months (49% vs 33%; P?<.01). However, by 12 months, there was no difference between the 2 groups (54.1% vs 50.3%; P?= –.53).

Combined therapy was not superior to either of the single therapies on any outcome measure at any of the timepoints. Therefore, initiating treatment with combined therapy is not recommended.

In an interview with Medscape Ob/Gyn Women's Health, Dr. Richter said that the study results will change how clinicians counsel their patients, because now there are more data to offer in terms of actual outcomes with respect to the 2 treatment modalities. "Essentially, we are trying to practice evidence-based medicine but we really didn't have any data with which to counsel women about the use of pessaries. We did have level?1 data for behavioral therapy, but nothing on pessaries."

She added that "those of us who use pessaries and behavioral therapy in our practices know that there are certain types of women who gravitate toward one [or the other] of these approaches.?.?.?. Even though at 3 months there seemed to be an advantage for behavioral therapy over pessary, as time goes on, the women who like the pessary and stay with it gain benefit. We hope to characterize factors or variables in women that predict success with pessary vs behavioral therapy use. However, as with any treatment modality, individualization of care continues to be important."

"I think it's an excellent study," Karen Noblett, MD, from the University of California at Irvine, said in an interview with Medscape Ob/Gyn Women's Health after Dr. Richter's presentation. "There are very few studies that look at the treatments of stress incontinence that are nonsurgical. Being able to have some validated and comparative data looking at the 2 nonsurgical options and then looking at the 2 therapies combined gives us good evidence that both are effective."

Elisa Trowbridge, MD, from the University of Virginia in Charlottesville, added that she was "thrilled" to hear that behavioral therapy was helpful, but admitted that she was a "very avid user of pessaries."

Pessaries are particularly useful in women who have comorbidities, she said. "They do work in a group of our patients. These are women have other medical problems and Kegels are just not an option for them. They have heart failure, mobility problems. Forget about trying to get to a therapist every week. So the continence pessary is still a great option for someone who has a lot of disability."

She added that weight loss is an excellent treatment for SUI. "I would have liked the study to have mentioned that."

The study was sponsored by the Eunice Kennedy Shriver National Institutes of Child Health and Human Development, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institutes of Health Office of Research on Women's Health, National Institutes of Health. Dr. Richter, Dr. Noblett, and Dr. Trowbridge have disclosed no relevant financial relationships.

American Urogynecologic Society (AUGS) 30th Annual Scientific Meeting: Paper 1. Presented September 24, 2009.