Stricker P, Haylen B
St Vincent's Clinic, Darlinghurst, NSW.
Med J Aust. 1993 Jan 18;158(2):89-91. doi: 10.5694/j.1326-5377.1993.tb137530.x.
To assess the safety, efficacy and durability of injectable glutaraldehyde cross-linked (GAX) collagen in the treatment of type 3 female stress incontinence.
A prospective study of incontinent women attending a private practice for clinical and urodynamic assessment.
Fifty women who had had an average of 1.8 previous operations for stress urinary incontinence took part in the study. Each had been diagnosed as having type 3 genuine stress incontinence (poor or nonfunctioning urethral sphincter mechanism in the presence of a bladder neck which is well supported, usually by scar tissue from previous surgery). Subject to a negative skin test for allergy, each patient underwent the implantation of GAX collagen (Contigen), a biocompatible product causing no foreign body reaction.
The implant was performed by a short day-only procedure involving cystoscopically controlled periurethral (71%) or transurethral (29%) injection of Contigen. The aim was to achieve closure of the urethra at the bladder neck and increase resistance to urine loss. Top-up injections were used as required. The follow-up period ranged from one to 21 months (mean, 11 months).
Of these first 50 female patients, 41 (82%) were successfully treated. Twenty-one (42%) were no longer incontinent; 20 (40%) desired no further treatment because their condition was improved; seven (14%) did not respond to treatment and two patients were awaiting top-up injections. The average number of injections given was 1.9 and the average volume injected was 14.4 mL. There were no allergic reactions or infections. Side effects were temporary and of a minor nature.
Injectable GAX collagen appears to be a safe and effective treatment for type 3 stress urinary incontinence. Its durability awaits further follow-up.
评估注射用戊二醛交联（GAX）胶原蛋白治疗3型女性压力性尿失禁的安全性、有效性和持久性。
一项针对在私人诊所接受临床和尿动力学评估的尿失禁女性的前瞻性研究。
50名平均曾因压力性尿失禁接受过1.8次手术的女性参与了该研究。每位患者均被诊断为3型真性压力性尿失禁（在膀胱颈通常由既往手术瘢痕组织良好支撑的情况下，尿道括约肌机制薄弱或无功能）。经皮肤过敏试验阴性后，每位患者接受了GAX胶原蛋白（Contigen）植入，这是一种无异物反应的生物相容性产品。
通过仅需一天的短程手术进行植入，包括经膀胱镜控制的尿道周围（71%）或经尿道（29%）注射Contigen。目的是实现膀胱颈处尿道闭合并增加抗尿失禁能力。根据需要进行补充注射。随访期为1至21个月（平均11个月）。
在这首批50名女性患者中，41名（82%）得到成功治疗。21名（42%）不再失禁；20名（40%）因病情改善无需进一步治疗；7名（14%）对治疗无反应，2名患者正在等待补充注射。平均注射次数为1.9次，平均注射量为14.4毫升。未发生过敏反应或感染。副作用为暂时性且轻微。
注射用GAX胶原蛋白似乎是治疗3型压力性尿失禁的一种安全有效的方法。其持久性有待进一步随访观察。
