Urology

KADINLARDA STRES İNKONTİNANSIN TEDAVİSİNDE CERRAHİ İLE KOLLAJEN ENJEKSİYONLARININ KARŞILAŞTIRILDIĞI ÇOK MERKEZLİ RANDOMİZE KLİNİK BİR ÇALIŞMA
KADINLARDA STRES İNKONTİNANSIN TEDAVİSİNDE CERRAHİ İLE KOLLAJEN ENJEKSİYONLARININ KARŞILAŞTIRILDIĞI ÇOK MERKEZLİ RANDOMİZE KLİNİK BİR ÇALIŞMA
J. CORCOS, J. P. COLLET, S. SHAPIRO, S. HERSCHORN, S. B. RADOMSKI, E. SCHICK, J. B. GAJEWSKI, A. BENEDETTI, E. MACRAMALLAH ve B. HYAMS
From the Department of Urology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada; Department of Epidemiology and Biostatistics, McGill University, and the Centre for Clinical Epidemiology and Community Studies, Sir Mortimer B. Davis Jewish General Hospital, Montreal, Quebec, Canada; Division of Urology, University of Toronto School of Medicine, Toronto, Ontario, Canada; Department of Urology, Université de Montréal, Montreal, Quebec, Canada; Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada; and Department of Radiology, McGill University, Montreal, Quebec, Canada
Article Language: TR
ÖZET
Amaç. Kollajen enjeksiyonları ile cerrahiyi, etkinlik, yaşam kalitesi, memnuniyet ve komplikasyonlar açısından, çok merkezli, randomize klinik bir çalışmada karşılaştırmak. Metodlar. Stres idrar inkontinansı olan 133 kadından 66'sı kollajen enjeksiyonu, 67'si de cerrahi (6 iğne ile mesane boynu süspansiyonu, 19 Burch ve 29 sling) uygulanmak üzere randomize edilmiştir. Randomizasyondan sonra, kadınların 15'i, ayrıldıkları tedavi grubuna katılmayı reddetmiştir. 'Tedavi amaçlanan' ve 'protokol uyarınca' analizleri yapılmıştır. Kollajen enjeksiyonu grubuna ayrılan kadınlarda, işlemin başarısız olduğu sonucuna, üç enjeksiyondan sonra varılmıştır. Tam iyileşmeden sonraki 3 ay içinde bir "ikmal" enjeksiyonuna izin verilmiştir. Birincil sonuç olan başarı, 12. ayda, sadece tayin edilen girişimin uygulanmasından sonra 24 saatlik ped testi sonucunun kuru (2.5 g veya daha az idrar) olması şeklinde tanımlanmıştır. Bulgular. Protokol uyarınca analizi, kollajen enjeksiyonundan 12 ay sonra elde edilen başarı oranının (%53), cerrahiden sonra elde edilen orana (%72.2) göre çok daha düşük olduğunu göstermiştir. Aradaki fark %19.1'dir (%95 güven aralığı %-36.2 ile %-2). Rand Tıbbi Sonuçlar çalışması 36 maddelik Sağlık Araştırması ve İnkontinans Etkisi Soru Formu ile ölçülen, genel ve hastalığa özgül yaşam kalitesi puanları, iki grupta benzer bulunmuştur (P= 0.306). Ortalama olarak, cerrahi ile tedavi edilen kadınların, kollajen enjeksiyonu ile tedavi edilenlere göre daha fazla memnun oldukları (sırasıyla %79.6 ve %67.2) gözlenmiştir; ancak aradaki fark anlamlı bulunmamıştır (P= 0.228). Son olarak, kollajen enjeksiyo-nunda komplikasyonların daha nadir ve daha düşük şiddette olduğu saptanmıştır: kollajen enjeksiyonu için 23 olguda 36 olay, cerrahi için 34 olguda 84 olay (P= 0.03). Sonuçlar. Girişimden bir yıl sonra, stres inkontinansın tedavisin-de kollajen enjeksiyonunun başarı oranı, cerrahininkinden %19 kadar daha düşük olmuştur. Bunun, her iki gruptaki yaşam kalitesi ve memnuniyet değişikliklerinin birbirine benzer ve cerahiden sonraki komplikasyonların sayı ve şiddetinin, kollajen enjeksiyonundan sonra görülenlere göre çok daha ağır olması ile dengelenmesi gerekir. Bu çalışmanın bulguları, stres idrar inkontinansının tedavisinde kollajen enjeksiyonlarının, cerrahiye, denemeye değer bir alternatif olabileceğini ortaya koymaktadır
ABSTRACT
Objectives. To compare, in a multicenter, randomized clinical trial, collagen injections versus surgery with regard to efficacy, quality of life, satisfaction, and complications. Methods. Of 133 women with stress urinary incontinence, 66 were randomized to collagen injection and 67 to surgery (6 needle bladder neck suspensions, 19 Burch, and 29 slings). After randomization, 15 women refused their allocated treatment. "Intent-to-treat" and "per protocol" analyses were applied. Women assigned to collagen injection could receive up to three injections before it was considered a failure. A "top-up" injection was allowed within 3 months after cure. Success as the primary outcome at 12 months was defined as a dry 24-hour pad test (2.5 g or less of urine) after having received only the allocated inter-vention. Results. The per protocol analysis showed that the success rate 12 months after collagen injections (53.1%) was much lower than that after surgery (72.2%). The difference was 19.1% (95% confi-dence interval -36.2% to -2%). The general and disease-specific quality-of-life scores measured by the Rand Medical Outcomes Study 36-item Health Survey and Incontinence Impact Question-naire were similar in the two groups (P= 0.306). Women treated by surgery were, on average, more satisfied (79.6%) than those treated by collagen injection (67.2%), but the difference was not significant (P= 0.228). Finally, complications were less frequent and severe with collagen injection: 36 events in 23 subjects for collagen injection versus 84 events in 34 subjects for surgery (P= 0.03). Conclusions. One year after intervention, the success rate of collagen injection as a treatment for stress urinary incontinence was about 19% lower than that after surgery. This has to be tempered by the similar changes in quality of life and satisfaction in both groups and that the number and severity of complications were much greater after surgery than after collagen injection. The results of this study indicate that collagen injections might be a worthwhile alternative to surgery for the treatment of stress urinary incontinence.

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