Andonian Sero, St-Denis Benoit, Lemieux Marie-Claude, Corcos Jacques
Department of Urology, Sir Mortimer B. Davis - Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
Eur Urol. 2007 Jul;52(1):245-51. doi: 10.1016/j.eururo.2006.12.035. Epub 2007 Jan 10.
Obtape and DUPS are modifications of the original TVT procedure. To test these new products in terms of safety and efficacy, we designed a prospective clinical trial with a follow-up of at least 1 yr.
We randomized 190 consecutive females with SUI for this study. They were evaluated by history, ICIQ-SF, physical examination, cystoscopy, UDS, and the 1-h pad test. Patients were reevaluated at 1, 6, and 12 mo. The ICIQ-SF and pad test were repeated at 1-yr follow-up.
There were 78, 32, and 80 patients in the Obtape, DUPS, TVT arms, respectively. An interim analysis after 32 patients in each arm indicated postoperative retention rates of 3 (9.4%), 6 (18.8%), and 4 (12.5%) patients in Obtape, DUPS, and TVT groups, respectively. Because of higher retention rate and suprapubic discomfort, DUPS was discontinued. At the end of the study, complete retention rates were 6 (7.8%), 6 (18.8%), and 6 (7.5%) in Obtape, DUPS, and TVT, respectively. TVT was the only procedure with bladder perforations at a rate of 14%. However, Obtape and DUPS were associated with more postoperative complications including complete retention, urethrolysis, hematoma, mesh erosion, UTI, and wound infection (13%, 28%, and 8%; p< or =0.025). At 1 yr, 83%, 94%, and 86% of patients in the Obtape, DUPS, and TVT groups were objectively cured (p>0.05).
TVT was the only procedure associated with bladder perforation, but there were more postoperative complications with Obtape and DUPS. No statistically significant differences in cure rates were observed at 1-yr follow-up. Longer follow-up is needed to confirm these results.
Obtape和DUPS是对原始经阴道无张力尿道中段吊带术（TVT）的改良术式。为了从安全性和有效性方面对这些新产品进行测试，我们设计了一项随访至少1年的前瞻性临床试验。
我们将190例连续性压力性尿失禁女性患者随机纳入本研究。通过病史、国际尿失禁咨询问卷-简表（ICIQ-SF）、体格检查、膀胱镜检查、尿动力学检查以及1小时护垫试验对她们进行评估。患者在1、6和12个月时接受重新评估。在1年随访时重复进行ICIQ-SF和护垫试验。
Obtape组、DUPS组和TVT组分别有78例、32例和80例患者。每组32例患者后的中期分析表明，Obtape组、DUPS组和TVT组术后尿潴留率分别为3例（9.4%）、6例（18.8%）和4例（12.5%）。由于较高的尿潴留率和耻骨上不适，DUPS被停止使用。在研究结束时，Obtape组（7.8%）、DUPS组（18.8%）和TVT组（7.5%）的完全尿潴留率分别为6例、6例和6例。TVT是唯一出现膀胱穿孔的术式，发生率为14%。然而，Obtape和DUPS与更多术后并发症相关，包括完全尿潴留、尿道松解术、血肿、网片侵蚀、尿路感染和伤口感染（分别为13%、28%和8%；p≤0.025）。在1年时，Obtape组、DUPS组和TVT组分别有83%、94%和86%的患者客观上治愈（p>0.05）。
TVT是唯一与膀胱穿孔相关的术式，但Obtape和DUPS术后并发症更多。在1年随访时未观察到治愈率有统计学显著差异。需要更长时间的随访来证实这些结果。
