Implantable microballoons: an attractive alternative in the management of intrinsic sphincter deficiency

All current bulking agents employed for treating stress urinary incontinence (SUI) have significant limitations due to various side effects, technical difficulties and inadequate long-term results. Implantable microballoons were therefore tested as a new therapeutic modality for female urinary incontinence.

The microballoons are implanted with a new system which consists of the self-detachable cross-linked silicone balloon, biocompatible filler material and a delivery system. Nineteen female patients (mean age 63.3 years) with SUI grade 1 or 2 were studied prospectively. Using the Blaivas-Olsson classification, 6 patients had stress incontinence type I, 4 had type II and 9 had type III. Three to seven balloons (mean 4.2) were implanted per patient. Patients were followed up with pad tests (g) and determination of leak point pressure (LPP; cm H2O) and maximal urethral closing pressure (Pura max; cm H2O) at 1, 3, 6, 12 and 18 months.

The biocompatibility of the microballoons was excellent. No significant adverse events were associated with the procedure. With a mean follow-up of 14.4 months (range 10-18) 42.1% (8/19) of the women are dry. In the latter the pad test improved from a preoperative mean of 22.6 g (2-75) to 0 and the LPP increased from a preoperative mean of 38.5 cm H2O (25-60) to 80.5 cm H2O (68-106). 36.8% (7/19) of the patients showed significant improvement of their incontinence. In this group the pad test improved from a preoperative mean of 39.1 g (8-112) to 9.7 g (2-29) and LPP from a mean of 37.1 cm H2O (25-50) to 42.0 cm H2O (30-58). In 4 patients (21.05%) the technique failed. Seven of the 8 cured patients had type III incontinence; the eighth patient had type I incontinence. It failed in all patients with type II incontinence.

The implantation of microballoons is a safe, well-tolerated and clinically effective modality for the treatment of type III SUI, i.e. intrinsic sphincter deficiency.