Gloria D'alessandro1,2, Maurizio Leone3, Jacopo Antolini4, Simone Ferrero3,5, Paolo Sala3, Guglielmo Melloni4, Giuseppe Fasolis4, Claudio Gustavino3. 1. Academic Unit of Obstetrics and Gynecology, San Martino IRCCS and Polyclinic Hospital, Genoa, Italy - gloria.dalessandro@libero.it. 2. Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Genoa, Italy - gloria.dalessandro@libero.it. 3. Academic Unit of Obstetrics and Gynecology, San Martino IRCCS and Polyclinic Hospital, Genoa, Italy. 4. Department of Urology, San Lazzaro Hospital, ASL-CN2, Alba, Cuneo, Italy. 5. Department of Neurosciences, Rehabilitation, Ophthalmology, Genetics, Maternal and Child Health (DiNOGMI), University of Genoa, Genoa, Italy.
Abstract
BACKGROUND: The purpose of the study is to report three years follow-up of single incision slings for the treatment of stress urinary incontinence (SUI). The main outcomes are to evaluate the efficacy of the device and to assess safety, adverse events, quality of life, demographic features of treated women and prognostic factors for SUI. METHODS: We performed a retrospective, double-center, single-arm study. Data were collected by medical records and a telephone interview 3 years after the implant of the mini-sling. Complication rate, subjective efficacy and degree of satisfaction were investigated. RESULTS: Fifty-four patients were treated between March 2015 and March 2017, of which 47 answered the survey. Forty-one of 47 procedures (87.2%) were considered effective. Among more relevant complications, there was one case of extrusion of mesh and three cases of new onset of urinary disfunction, of which two cases of urgency urinary incontinence (UUI) and one case of de-novo SUI. Most complications were solved within few days after the procedure. Concerning the subjective impression of improvement, investigated by using the Patient Global Impression of Improvement (PGI-I) questionnaires, 41 patients reported subjective satisfaction, three reported no change in quality of life and three patients had worsening of symptoms. CONCLUSIONS: The procedure was safe and effective for the treatment of SUI but more data are needed to confirm our preliminary results.
BACKGROUND: The purpose of the study is to report three years follow-up of single incision slings for the treatment of stress urinary incontinence (SUI). The main outcomes are to evaluate the efficacy of the device and to assess safety, adverse events, quality of life, demographic features of treated women and prognostic factors for SUI. METHODS: We performed a retrospective, double-center, single-arm study. Data were collected by medical records and a telephone interview 3 years after the implant of the mini-sling. Complication rate, subjective efficacy and degree of satisfaction were investigated. RESULTS: Fifty-four patients were treated between March 2015 and March 2017, of which 47 answered the survey. Forty-one of 47 procedures (87.2%) were considered effective. Among more relevant complications, there was one case of extrusion of mesh and three cases of new onset of urinary disfunction, of which two cases of urgency urinary incontinence (UUI) and one case of de-novo SUI. Most complications were solved within few days after the procedure. Concerning the subjective impression of improvement, investigated by using the Patient Global Impression of Improvement (PGI-I) questionnaires, 41 patients reported subjective satisfaction, three reported no change in quality of life and three patients had worsening of symptoms. CONCLUSIONS: The procedure was safe and effective for the treatment of SUI but more data are needed to confirm our preliminary results.