Meschia Michele, Barbacini Pietro, Baccichet Roberto, Buonaguidi Arturo, Maffiolini Marco, Ricci Luisa, Braghin Chiara, Brusati Valentina, Dell'Utri Chiara, Spreafico Lorenzo
Department of Obstetrics and Gynecology, Ospedale G. Fornaroli, Magenta, Milan, Italy.
Int Urogynecol J. 2011 Feb;22(2):177-82. doi: 10.1007/s00192-010-1254-6. Epub 2010 Aug 27.
To evaluate the efficacy and safety of the minimally invasive Ajust™ system in the treatment of stress urinary incontinence.
This was a prospective multicentre study. All patients with primary urodynamic stress urinary incontinence were prospectively selected to receive the Ajust™ procedure. The International Consultation on Incontinence-Short Form (ICI-SF), Women Irritative Prostate Symptoms Score (W-IPSS), PGI-S, and PGI-I questionnaires were used to evaluate the impact of incontinence and voiding dysfunction on QoL and to measure patient's perception of incontinence severity and improvement.
From January 2009 to October 2009, 111 consecutive subjects were enrolled in the study. At 6 months, 102 were available for outcomes analysis. The subjective and objective cure rates were 85.7% and 91.4%, respectively. The ICI-SF and W-IPSS questionnaires showed a statistical significant improvement in symptom scores.
In the short-term follow-up, the Ajust™ system was effective in restoring continence in more than 85% of subjects with a highly significant improvement in QoL.
评估微创Ajust™系统治疗压力性尿失禁的疗效与安全性。
这是一项前瞻性多中心研究。所有原发性尿动力学压力性尿失禁患者均被前瞻性地选入接受Ajust™手术。采用国际尿失禁咨询委员会简表（ICI-SF）、女性刺激性前列腺症状评分（W-IPSS）、PGI-S和PGI-I问卷来评估尿失禁和排尿功能障碍对生活质量的影响，并衡量患者对尿失禁严重程度及改善情况的感知。
2009年1月至2009年10月，共有111名连续受试者纳入本研究。6个月时，102名受试者可进行结果分析。主观治愈率和客观治愈率分别为85.7%和91.4%。ICI-SF和W-IPSS问卷显示症状评分有统计学意义的改善。
在短期随访中，Ajust™系统能使超过85%的受试者恢复控尿功能，生活质量有显著改善。
