A Minimally Invasive, Outpatient, Office Procedure for Severe Stress Urinary Incontinence in Women: Luksenburg Systems LSG3

Abstract

The worldwide prevalence of female urinary incontinence (UI) is reported at 55%, and about 27% of UIs are severe. The complications in cases of severe UI treated surgically and the ineffective or incomplete results of prolonged treatments with thermal energies motivated us to develop an innovative treatment. Our hypothesis was based on correcting the descent and/or urethral hypermotility and repositioning the descended bladder urethral junction. We have designed a system for the development of a dense and resistant fibrosis that supports the urethra and can correct the alterations of severe UI, Luksenburg systems procedure, LSG3. A group of 652 women between the age of 46 and 74 years, post-menopausal, with more than 2 vaginal births and severe UI, documented by the clinical presentation and the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) score index, were enrolled. Originally developed polycaprolactone threads were placed in suburethral space using specific designed tools (LSG3). Immediate results—24 hours (P < .05): 469 patients without clinical UI (72% efficacy), 122 patients with grade 1 UI (drops) (18% improvement), and 59 patients with grade 3 UI (unchanged 9%). Thirty-day results (P < .05): 560 patients without UI (86% efficacy), 58 patients with grade 1 UI (drops) (9% improvement), and 34 patients with grade 3 UI (unchanged 5%). Fifteen-month results (P < .05): 542 patients without UI (83%), 74 patients with grade 1 UI (drops) (11%), and 36 patients with grade 3 UI (6%). No complications or secondary effects were found after the procedure in the 15 months of follow-up. We have developed an innovative system called “suburethral spider web” to treat and cure severe (grade 3) UI in office, as outpatient, that is effective, safe, and cheap.