Implantable Microballoons: An Attractive Alternative in the Management of Intrinsic Sphincter Deficiency

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Abstract
Purpose: 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. Material and Methods: 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. Results: 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. Conclusion: 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.

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