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An open study of the bladder neck support prosthesis in genuine stress incontinence
Objective:
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.
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 test, 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 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.
Conclusions:
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.