Peri-urethral silicone microimplants (Macroplastique) for the treatment of genuine stress incontinence

To establish the safety and efficacy of the periurethral injection of silicone microimplants (Macroplastique) for the treatment of genuine stress incontinence in women.

Forty women (median age 50 years, range 27-74) with genuine stress incontinence confirmed on medium-fill video-cystometry were recruited to the study. Macroplastique (3-7 mL) was injected periurethrally 1 cm distal to the bladder neck at three or four points 'around the clock' under cystoscopic control. Where possible, the urodynamic study was repeated after 3 months. Results were graded as excellent (dry, no protection), good (better, but not totally dry) or poor (no improvement).

Three months after a single injection, 16 (40%) were completely dry, 13 (33%) were improved and 11 (27%) were no better. Four patients who were improved were rendered dry by a second injection. After 3 years, 16 (40%) remained completely dry, seven (18%) were improved and 17 (42%) required alternative treatment with a Stamey bladder neck suspension. Dysuria for 48 h occurred in almost all patients; two were catheterized overnight and one required a catheter for 6 weeks. A comparison of maximum voiding pressures and flow rates before and 3 months after a single injection of Macroplastique revealed no urodynamic evidence of obstructed voiding (n = 25).

Injectable silicone microimplants produced a good to excellent result in 73% of patients in the short-term and 58% of women maintained this response after 3 years. The injection is a day-case procedure which provides a satisfactory medium-term outcome in over half of patients with genuine stress incontinence. There are few side-effects and those patients with no improvement may go on to be treated by open surgery without complication.