An open study of the bladder neck support prosthesis in genuine stress incontinence

Objective To determine the proportion of unselected women with genuine stre ss incontinence in whom a bladder neck support prosthesis could be fitted s uccessfully by three gynaecologists with no prior knowledge of the device, and to measure efficacy of the device. Design Prospective interventional study. Setting Two metropolitan urodynamic units. Sample Eighty women with genuine stress incontinence. Main outcome measures 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 t est, and urine flow rate. Results 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 medica l reasons. In five women (13%) the device was never effective; six withdrew because of adverse events and two required devices that were larger or sma ller 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 thre e declined to complete all outcome measures. Urine now rates revealed no ev idence of outflow obstruction. At the sixth month, 18 of 26 patients (69%) were wearing the device successfully; 15 of these women continued to the 12 th month, and all but one were objectively dry. Conclusions The bladder neck support prosthesis is a useful addition to the range of treatments available for the management of genuine stress inconti nence, but may be difficult to fit in women who are oestrogen-deprived or h ave undergone multiple surgical procedures. The demands of the trial protoc ol were found to be onerous by frail elderly women.