Intraurethral sphincter prosthesis to treat hyporeflexic bladders in women: does it work?

Objective To assess the efficacy and safety of a new intraurethral sphincte r prosthesis to treat hyporeflexic bladders in women. Patients and methods Between July 1997 and December 1998, 18 women (mean ag e 45.8 years, range 26-84) with neurogenic voiding disorders and a hyporefl exic bladder were examined prospectively. All but one patient (who used the Crede manoeuvre) emptied their bladder using clean intermittent catheteriz ation. The women were fitted with a prosthesis consisting of a valve and a pump inside a short self-retaining silicone device, which was activated by a magnetic remote control unit. The evaluation before implantation comprise d a medical history, a neurological evaluation, urodynamic recordings and u rine cultures. The followup after implantation included a monthly clinical assessment, a symptom questionnaire, urine culture, ultrasonographic examin ations and replacement of the device if necessary. Urine samples were also cultured if there was any discomfort or fever. Results At 16 months of follow-up, only six of 18 patients continued to use the implant (mean followup 9.6 months) and were satisfied. In 10 patients major incontinence around the catheter, or irritation, led to removal of th e device. Two patients were unable to learn how to transfer to the toilet t o empty their bladder; therefore, their implant was removed and they were t reated with a suprapubic catheter. Two patients died from unrelated causes. Twelve patients had positive bacteriuria while fitted with the device; six of them became symptomatic. Usually, only symptomatic lower urinary tract infections were treated. Technical problems occurred often; 14 catheters sh owed technical dysfunction and had to be replaced early and three external remote control units broke for no reason. Despite normal short-term cystosc opic findings (three patients), long-term urethral damage cannot be exclude d. Indeed, the six patients who remain fitted with the device already show some widening of their urethra. Conclusion This experience with the new device was disappointing; in eight of the 18 patients incontinence appeared or worsened and led to removal of the device. Technical problems were common. The other concern is that signi ficant long-term urethral damage could be expected, as observed with indwel ling catheters over time. Thus, although this device may function for a sho rt period, it is unsuitable for long-term use.