羅曼死 2010-6-23 10:35
對復發尿失禁女性有效的新裝置
作者：Jill Stein
出處：WebMD醫學新聞
June 2, 2010 (舊金山) – 研究者在美國泌尿科協會2010年科學會議中報告指出，一種研發中的微創裝置、可調式節制治療(Adjustable Continence Therapy [ACT，Uromedica公司])，似乎可有效治療括約肌本身缺乏或缺陷(intrinsic sphincter deficiency)相關的壓力型尿失禁(stress urinary incontinence ，SUI)婦女的復發。
共同研究者、加州洛杉磯Kaiser Permanente的神經與重建手術計畫主任Sherif Aboseif醫師向Medscape Urology表示，手術失敗後復發SUI依舊是一個有挑戰性的問題。這可能是因為膀胱輸尿管片段的持續過動、或者尿道壁閉水度不足導致的括約肌本身缺乏或缺陷，腹內壓力略為增加。
他接著表示，中段尿道吊帶手術(Midurethral slings)被視為真正SUI的治療首選，不過，在復發案例中，中段尿道吊帶手術可能和高發病率有關，促使發展許多微創選項，希望對減少發病率可以提供合理的效果。微創選項包括尿道植入物注射、將幹細胞注射進入橫紋括約肌，以及可調式節制治療裝置。
Aboseif醫師表示，我們的結果認為，對於這些具有挑戰性的SUI復發病患，ACT系統可以是一種有效、簡單、安全的微創治療方式，所有復發尿失禁婦女都適用這種治療。
【可調式裝置有不錯的期中結果】
ACT裝置藉由可調式矽球在膀胱頸提供填充，有助於尿道閉水度和膀胱頸支持。每個氣球連接到一個埋入大陰唇的鈦開孔，術後可以調整氣球以達到最大效果。
研究者報告迄今植入此裝置的162名婦女的資料，其中分別有142、84和57人完成至少1、2和3年的追蹤。
所有婦女都有復發SUI，合併或未合併尿道過動。多數接受過至少1種抗失禁手術，將近半數接受至少2種未成功的手術。
在開始時檢測，之後在第6週、第3、6、9和12個月時進行追蹤檢測，之後每年檢測一次，包括刺激墊重量檢測(provocative pad weight test，PPWT)和確認問卷。
結果顯示，在1年時，Stamey分數減少至少1級者有75.4% (107/142名病患)、2年時有75.0% (63/8名病患)、3年時有83.9% (47/56名病患)。
進行手術植入裝置的困難度，排比為輕微者有62%的案例、中度有29%、嚴重有9%。
平均PPWT從開始時的48.9、44.3和44.5g分別降低到1、2和3年時的11.8、8.9和8.4g(P< .001)。
乾燥率定義為PPWT小於2g，分別是50.8%、63%和71.4%，1、2和3年時分別是79.7%、88.7%和83.3%，改善幅度超過50%。
確認問卷用來評估壓力型失禁程度、排尿障礙、性功能，整體生活品質顯示在追蹤3年時，各項測量都有顯著改善(P< .001)。
達到最大節制效果所需的氣球調整次數平均為2.9，裝置或手術相關併發症(氣球穿孔、開孔或氣球糜爛、氣球位置移動、開孔或氣球相關疼痛或不適、間歇性尿滯留)在第1年的報告率有25% (39/156名病患)，第2年時為18.6% (21/113名病患)、第3年時為13.7% (10/73名病患)，多數併發症被視為輕微且容易處置。
南加州Myrtle Beach、加州泌尿科研究中心/亞特蘭大泌尿科診所主任Neal Shore醫師在受訪時向Medscape Urology表示，依據篩選準則，傳統的吊帶治療成功率為15%-30%，相當樂見可用於難治型失禁的策略，特別是可以減少病患發病率和改善長期效果的話。
這篇研究在美國與加拿大的9處中心進行，接受Uromedica公司資助。Aboseif 醫師和Shore醫師皆宣告沒有相關財務關係。
美國泌尿科協會2010年科學會議：摘要1504。發表於2010年6月1日。
New Device is Effective for Recurrent Female Urinary Incontinence
By Jill Stein
Medscape Medical News
June 2, 2010 (San Francisco) – An investigational minimally invasive device, known as the Adjustable Continence Therapy (ACT, Uromedica, Inc.) system, seems to be an effective treatment for women with recurrent episodes of stress urinary incontinence (SUI) associated with intrinsic sphincter deficiency, researchers reported here at the American Urological Association 2010 Annual Scientific Meeting.
"Recurrent SUI after a failed surgical procedure continues to be a challenging problem," coinvestigator Sherif Aboseif, MD, director of the Neurourology and Reconstructive Surgery Program at Kaiser Permanente in Los Angeles, California, told Medscape Urology. "It can result from either persistent hypermobility of the vesicourethral segment or from [intrinsic sphincter deficiency] due to lack of coaptation of the urethral wall in response to a slight increase in intra-abdominal pressure."
Midurethral slings are considered the treatment of choice for genuine SUI, he continued. However, in recurrent cases, midurethral slings can be associated with high morbidity, which has led to the development of several minimally invasive options that "provide the hope of reasonable efficacy associated with minimal morbidity." Minimally invasive options include injections of bulking agents, injection of stem cells into the rhabdosphincter, and adjustable continence therapy devices.
"Our results suggest that the ACT system can be an effective, simple, safe, and minimally invasive treatment for recurrent SUI in a challenging group of patients. All women with recurrent incontinence are good candidates for this therapy," Dr. Aboseif said.
Good Mid-Term Results Seen With the Adjustable Device
The ACT device provides bulk at the bladder neck, with adjustable silicone balloons for urethral coaptation and bladder neck support. Each balloon is attached to a titanium port buried in the labia majora, allowing for postoperative titration of the balloons for maximal efficacy.
The investigators reported results from the 162 women implanted thus far, of whom 142, 84, and 57 have completed, respectively, at least 1, 2, and 3 years follow-up.
All women had recurrent SUI with or without urethral hypermobility. Most had undergone at least 1 previous anti-incontinence procedure, and nearly half had undergone at least 2 unsuccessful procedures.
Baseline and follow-up tests were performed at 6 weeks, at 3, 6, 9, and 12 months, and annually thereafter, and included the provocative pad weight test (PPWT) and validated questionnaires.
Results showed that a Stamey score reduction of at least 1 grade was achieved in 75.4% (107 of 142 patients) at 1 year, 75.0% (63 of 84 patients) at 2 years, and 83.9% (47 of 56 patients) at 3 years.
The difficulty of performing surgery to implant the device was rated as mild in 62% of cases, moderate in 29%, and severe in 9%.
The mean PPWT decreased from 48.9, 44.3, and 44.5?g at baseline, to 11.8, 8.9, and 8.4?g at 1, 2, and 3 years, respectively (P?< .001).
Dry rate, defined as less than 2?g on PPWT, was 50.8%, 63%, and 71.4%, respectively, and improved more than 50% in 79.7%, 88.7%, and 83.3% of patients at 1, 2, and 3 years, respectively.
Validated questionnaires assessing the degree of stress incontinence, voiding dysfunction, sexual function, and overall quality of life showed significant improvements on all measures during the 3 years of follow-up (P?< .001).
The mean number of balloon adjustments required to achieve maximum continence was 2.9. Device or procedure-related complications (bladder perforation, port or balloon erosion, balloon migration, port- or balloon-related pain or discomfort, and intermittent urinary retention) were reported in 25% (39 of 156 patients) during the first year, 18.6% (21 of 113 patients) during the second year, and 13.7% (10/73 patients) during year the third year. Most complications were considered mild and easily managed.
"Traditional sling therapies are unsuccessful in 15% to 30% of patients based on selection criteria," Neal Shore, MD, FACS, director of Carolina Urologic Research Center/Atlantic Urology Clinics in Myrtle Beach, South Carolina, told Medscape Urology in an interview. "Innovative strategies for addressing refractory incontinence are always welcome, especially if they can minimize patient morbidity and improve long-term efficacy."
The study, which was carried out at 9 centers in the United States and Canada, was funded by Uromedica, Inc. Dr. Aboseif and Dr. Shore have disclosed no relevant financial relationships.
American Urological Association (AUA) 2010 Annual Scientific Meeting: Abstract?1504. Presented June?1, 2010.