Moore K N, Chetner M P, Metcalfe J B, Griffiths D J
Faculty of Nursing, University of Alberta, Edmonton, Canada.
Br J Urol. 1995 Mar;75(3):359-63. doi: 10.1111/j.1464-410x.1995.tb07349.x.
To evaluate the effectiveness of periurethral collagen (Contigen) implantation as a treatment for stress incontinence, using quantitative measures of urine loss and the patients' subjective response.
Twelve women, age range 46-87 years, had video urodynamic testing--confirming Type I or III stress urinary incontinence and were eligible for periurethral collagen implant. Eleven had had at least one anti-incontinence operation. One woman was withdrawn from the study because of a severe subcutaneous skin reaction 21 days after the skin-test and one patient declined follow-up. Ten patients had up to two implants each, introduced 3-5 months apart under local anaesthetic (5 mL collagen per implant). All patients underwent 10 h pad tests (with 2-hourly pad changes) at baseline and 8 weeks after collagen implant. The following quantitative measures of incontinence severity and voiding function were studied: urine loss during the 10 h test, number of wet pads, weight of urine in the wettest pad, maximum voided volume, residual volume on ultrasound, maximum flow rate and urinary flow curve pattern. Blind to the quantitative results, patients were asked to categorize their outcome as cured, improved and failed.
There was a significant decrease in urine loss (P = 0.007), number of wet pads (P = 0.05) and weight of the wettest pad (g) (P = 0.03) from baseline to 8 weeks after the second collagen implant. There was no significant difference at any point in maximum voided volume, maximum urinary flow rate and residual volume after voiding measured on ultrasound. Objectively, two women appeared cured (< 5 g urine loss on 10 h pad test); subjectively, both reported themselves as improved (not cured); one subject stated she was cured and on pad test had 11 g urine loss; two women stated there was no change yet urine loss decreased markedly by > 60% from 434 g to 123 g and 533 g to 199 g. The remaining six stated they were improved although, objectively, their urine loss after the collagen implant remained high (mean 132 g, range 87-185).
These results show a significant reduction in urine loss at 8 weeks after the second collagen implant and an objective cure rate of 18%. There was little relationship between the objective measure of success and the self-report. Of interest is the fact that no obstructive changes occurred in the voided amount, the flow curve and the residual volume after voiding.
采用尿失禁定量测量方法及患者主观反应，评估尿道周围胶原蛋白（Contigen）植入术治疗压力性尿失禁的有效性。
12名年龄在46至87岁之间的女性接受了影像尿动力学检查，确诊为I型或III型压力性尿失禁，符合尿道周围胶原蛋白植入术条件。其中11名患者至少接受过一次抗尿失禁手术。一名女性在皮肤试验21天后因严重的皮下皮肤反应退出研究，一名患者拒绝随访。10名患者每人最多接受两次植入，每次植入间隔3至5个月，在局部麻醉下进行（每次植入5毫升胶原蛋白）。所有患者在基线时及胶原蛋白植入后8周均接受10小时的尿垫试验（每2小时更换一次尿垫）。研究了以下尿失禁严重程度和排尿功能的定量指标：10小时试验期间的尿量损失、尿垫浸湿数量、最湿尿垫中的尿量、最大排尿量、超声测量的残余尿量、最大尿流率及尿流曲线模式。在不知定量结果的情况下，要求患者将其结果分为治愈、改善和失败三类。
从基线到第二次胶原蛋白植入后8周，尿量损失（P = 0.007）、尿垫浸湿数量（P = 0.05）和最湿尿垫重量（克）（P = 0.03）均显著减少。在超声测量的最大排尿量、最大尿流率及排尿后残余尿量方面，任何时间点均无显著差异。客观上，两名女性似乎治愈（10小时尿垫试验尿量损失<5克）；主观上，两人均称自己有所改善（未治愈）；一名受试者称自己已治愈，但尿垫试验尿量损失为11克；两名女性称无变化，但尿量损失从434克显著减少至123克以及从533克显著减少至199克，降幅>60%。其余六名女性称自己有所改善，尽管客观上她们在胶原蛋白植入后的尿量损失仍然很高（平均132克，范围87 - 185克）。
这些结果显示，第二次胶原蛋白植入后8周尿量损失显著减少，客观治愈率为18%。成功的客观测量与自我报告之间几乎没有关联。有趣的是，排尿量、尿流曲线及排尿后残余尿量均未出现梗阻性变化。
