title: Implantable microballoons: an attractive alternative in the management of intrinsic sphincter deficiency.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Urology, University of Vienna, Austria. uroldep@akh-wien.ac.at
authors.forename: A
authors.initials: A
authors.lastname: Pycha
authors.forename: C H
authors.initials: CH
authors.lastname: Klingler
authors.forename: A
authors.initials: A
authors.lastname: Haitel
authors.forename: G
authors.initials: G
authors.lastname: Heinz-Peer
authors.forename: M
authors.initials: M
authors.lastname: Marberger
mesh_terms: D000328:Adult; D000368:Aged; D001672:Biocompatible Materials; D002404:Catheterization / Q000295:instrumentation*; D004867:Equipment Design; D005260:Female; D006801:Humans; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D019736:Prostheses and Implants; D001743:Urinary Bladder / Q000473:pathology; D014550:Urinary Incontinence, Stress / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D014563:Urodynamics; D013520:Urologic Surgical Procedures / Q000295:instrumentation* / Q000379:methods
chemical_list: D001672:Biocompatible Materials