RESUMEN
PURPOSE: All current bulking agents employed for treating intrinsic sphincter deficiency (ISD) have some limitations due to various side effects, technical difficulties and inadequate long-term results. Self-detachable balloon system (SDBS) was tested as a new therapeutic modality for female urinary incontinence. MATERIALS AND METHODS: SDBS which consists of the self-detachable cross-linked silicone balloon, biocompatible filler material and a delivery system was implanted. Fourteen famale patients with ISD were included in the prospective trials. Two to five balloons were implanted per patient. Patients were followed up with incontinence questionnaire, pad tests and determination of Valsalva leak point pressure (VLPP) at 1, 3, 6, 12 and 18 months. RESULTS: The biocompatibility of the microballoons was excellent. With a mean follow-up of 10.1 months, 28.9% (4/14) of the patients were completely dry. 21.1% (3/14) of the patients showed socially dry and 3 patients (21.1%) showed improvement. 28.9% (4/14) of patients were deteriorated during follow-up. Three patients had spontaneous delivery of SDBS. The pad test improved from a preoperative mean of 102.1g to a postoperative mean of 22.4g. The VLPP increased from a preoperative mean of 49.7cmH2O to a postoperative mean 89.8cmH2O. CONCLUSIONS: The implantation of microballoons is a safe, well-tolerated, minimally invasive and clinically effective modality for the treatment of ISD.