Ajust~与TVT-O^(TM)治疗压力性尿失禁的前瞻性研究

The Prospective Study of Ajust~ and TVT-O^(TM) in the Treatment of SUI

目的:比较Ajust与TVT-OTM对于治疗女性压力性尿失禁的主观/客观治愈率、术后疼痛感、术后并发症,以及对于生活质量的影响。方法:将2012年1月—2013年5月期间收治的327例压力性尿失禁(SUI)患者随机分为Ajust手术组163例、TVT-OTM手术组164例。采用治愈率、手术并发症、术后疼痛感、患者整体印象改善度(Patient Global Impression of Improvement,PGI-I)、尿失禁问卷表简表(ICIQ-SF)评价疗效。结果:Ajust组患者术后疼痛感较TVT-OTM组显著减轻(P<0.05)。Ajust组手术时间及术中出血量小于TVT-OTM组(P=0.00)。2组围手术期并发症差异无统计学意义(P>0.05)。Ajust组与TVT-OTM组比较,主观治愈率及客观治愈率差异无统计学意义(分别为92.0%比89.6%和95.1%比93.9%,P>0.05)。Ajust组患者术后可以更早恢复正常生活(P=0.00)。2组患者术后生活质量评分较术前均有显著提高(P=0.00),但2组患者生活质量平均改善情况差异无统计学意义(P=0.235)。结论:Ajust治疗SUI操作简便,安全有效。与TVT-OTM相比手术简便快捷,术中出血少,术后疼痛程度轻,恢复时间短。

Objective：To compare the patient-reported and objective cure rates, postoperative pain, postoperative complications, and postoperative quality of life of Adjustable Single-incision Sling（Ajust） versus Tension-free Vaginal Tapeobturator（TVT-O^TM） in the treatment of female stress urinary incontinence（SUI）. Methods：A randomised trial was conducted in the period between January 2012 and May 2013, with the 327 SUI female patients randomised to either Ajust group（163 cases）or TVT-O^TM group（164 cases）. Evaluations were performed to compare the patient-reported and objective cure rates,postoperative complications, postoperative pain profile using Visual Analogue Scale（VAS）, Patient Global Impression of Improvement Scale（PGI-I） and International Consultation on Incontinence Questionnaire-Short Form（ICIQ-SF） of these two groups. Results：Compared with the TVT-O^TMgroup, patients in the Ajust group had a significantly lower postoperative pain（P〈0.05）, shorter operative duration, and less intraoperative blood loss（P =0.00）. No significant difference in peri-operative complications was shown between these two groups. Patient-reported and objective cure rates between the Ajust and TVT-O^TM groups were： 92.0% versus 89.6% and 95.1% versus 93.9% respectively, but this did not reach statistical significance（P〉0.05）.In comparison with the TVT-O^TMgroup, the Ajust group showed an earlier recovery to normal activities（P=0.00）. It is proved in PGI-I that both Ajust and TVT-O^TM groups had a significant improvement of life quality（P=0.00）, but no significant difference was shown about the average improvement of life quality between these two groups（P=0.235）. Conclusions：Ajust procedure is simple, safe and effective treatment of SUI. Compared with TVT-O^TM, Ajust is simpler and faster, less intraoperative blood loss,generates less postoperative pain and quicker recovery.