Moore K H, Foote A, Burton G, King J
St George Hospital, University of New South Wales, Sydney, Australia.
Br J Obstet Gynaecol. 1999 Jan;106(1):42-9. doi: 10.1111/j.1471-0528.1999.tb08083.x.
To determine the proportion of unselected women with genuine stress incontinence in whom a bladder neck support prosthesis could be fitted successfully by three gynaecologists with no prior knowledge of the device, and to measure efficacy of the device.
Prospective interventional study.
Two metropolitan urodynamic units.
Eighty women with genuine stress incontinence.
Average number of leaks per day on a frequency volume chart, average number of pads worn per day, urine loss on a one-hour pad test, and urine flow rate.
Of the 80 recruits, 11 had exclusion criteria and four could not be fitted at the first visit. Of 65 participants, 39 (58%) withdrew from the study before week four. In 20 of 39 women (51%) post-surgical scarring made fitting difficult, and six (15%) withdrew for unrelated personal or medical reasons. In five women (13%) the device was never effective; six withdrew because of adverse events and two required devices that were larger or smaller than those presently available. Thus 38 of 65 participants (58%) could be fitted by the three gynaecologists. Of 26 women who wore the device for four weeks, median leaks per day fell from 2.5 (interquartile range (IQR) 1.9-4.6) to 1.0 (IQR 0-2); median number of pads per day fell from 1.5 (IQR 0.5-3) to 0 (IQR 0-1); and median pad test loss fell from 19 g/h (IQR 8-49) to 2 g/h (IQR 0-8). Sixteen of these 26 patients (62%) achieved objective success, six (23%) were socially continent, one failed to respond and three declined to complete all outcome measures. Urine flow rates revealed no evidence of outflow obstruction. At the sixth month, 18 of 26 patients (69%) were wearing the device successfully; 15 of these women continued to the 12th month, and all but one were objectively dry.
The bladder neck support prosthesis is a useful addition to the range of treatments available for the management of genuine stress incontinence, but may be difficult to fit in women who are oestrogen-deprived or have undergone multiple surgical procedures. The demands of the trial protocol were found to be onerous by frail elderly women.
确定在未经过筛选的真性压力性尿失禁女性中，三位对该器械毫无先验知识的妇科医生能够成功植入膀胱颈支撑假体的比例，并评估该器械的疗效。
前瞻性干预性研究。
两个大城市的尿动力学单位。
80例真性压力性尿失禁女性。
频率-尿量图表上每天的平均漏尿次数、每天使用的护垫平均数量、1小时护垫试验中的尿失禁量以及尿流率。
80名招募者中，11人有排除标准，4人在首次就诊时无法植入。65名参与者中，39人（58%）在第4周前退出研究。在39名女性中的20人（5I%），术后瘢痕形成导致植入困难，6人（15%）因个人或医疗无关原因退出。5名女性（13%）该器械从未有效；6人因不良事件退出，2人需要尺寸与现有器械不符的器械。因此，65名参与者中的38人（58%）能够被三位妇科医生成功植入。在佩戴该器械4周的26名女性中，每天漏尿的中位数从2.5次（四分位间距（IQR）1.9 - 4.6）降至1.0次（IQR 0 - 2）；每天使用护垫的中位数从1.5片（IQR 0.5 - 3）降至0片（IQR 0 - 1）；护垫试验中的尿失禁量中位数从19克/小时（IQR 8 - 49）降至2克/小时（IQR 0 - 8）。这26名患者中的16人（62%）取得了客观成功，6人（23%）在社交场合无尿失禁，1人无反应，3人拒绝完成所有观察指标。尿流率未显示有流出道梗阻的证据。在第6个月时，26名患者中的18人（69%）仍在成功佩戴该器械；其中15名女性持续到第12个月，除1人外均客观上无尿失禁。
膀胱颈支撑假体是真性压力性尿失禁现有治疗方法的有益补充，但对于雌激素缺乏或接受过多次手术的女性可能难以植入。体弱的老年女性认为试验方案要求过高。
