title: An Open Multicenter Study of Clinical Efficacy and Safety of Urolastic, an Injectable Implant for the Treatment of Stress Urinary Incontinence: One-Year Observation.
abstract: The prevalence of stress urinary incontinence rises and affects up to 30% of women after 50 years of age. Midurethral slings are currently the mainstay of surgical anti-incontinence therapy. Some patients experience recurrent SUI (RSUI) which is defined as a failure of anti-incontinence surgery after a period of time or persistence of SUI after the procedure aimed at correcting it. The urethral bulking agent application decreases invasiveness of treatment and meets patients requirements. The objective of this study was to assess the safety and clinical efficacy of Urolastic injection. One hundred and five patients with SUI (including 91 patients with RSUI) were treated with Urolastic in three tertiary gynecological clinics. The efficacy of the procedure was assessed objectively at each follow-up visit by means of cough test and a standard 1-hour pad test. Objective success rate after 12 months after primary procedure in RSUI patients was found in 59.3% of patients. In 14 patients with primary SUI improvement after 1 year was found in 71.4% of patients. Although cure rates after MUS are up to 90% there is still place for less invasive treatment option like periurethral injection of bulking agents, especially in patients with previous SUI surgical management.
authors.affiliation: 2nd Department of Gynecology, Medical University of Lublin, Ulica Jaczewskiego 8, 20-954 Lublin, Poland.
authors.forename: Konrad
authors.identifier: 0000-0001-7864-666X
authors.initials: K
authors.lastname: Futyma
authors.affiliation: 2nd Department of Gynecology, Medical University of Lublin, Ulica Jaczewskiego 8, 20-954 Lublin, Poland.
authors.forename: Paweł
authors.initials: P
authors.lastname: Miotła
authors.affiliation: 2nd Department of Gynecology, Medical University of Lublin, Ulica Jaczewskiego 8, 20-954 Lublin, Poland.
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Gałczyński
authors.affiliation: Department of Gynecology and Gynecologic Oncology, Military Institute of Medicine, Ulica Szaserów 128, 04-141 Warsaw, Poland.
authors.forename: Włodzimierz
authors.initials: W
authors.lastname: Baranowski
authors.affiliation: Department of Gynecology and Gynecologic Oncology, Military Institute of Medicine, Ulica Szaserów 128, 04-141 Warsaw, Poland.
authors.forename: Jacek
authors.initials: J
authors.lastname: Doniec
authors.affiliation: Department of Gynecology and Gynecologic Oncology, Military Institute of Medicine, Ulica Szaserów 128, 04-141 Warsaw, Poland.
authors.forename: Agnieszka
authors.identifier: 0000-0002-6040-7158
authors.initials: A
authors.lastname: Wodzisławska
authors.affiliation: Department of Gynecology and Gynecologic Oncology, Medical University of Białystok, Ulica M. Skłodowskiej-Curie 24a, 15-276 Białystok, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Jóźwik
authors.affiliation: Department of Gynecology and Gynecologic Oncology, Medical University of Białystok, Ulica M. Skłodowskiej-Curie 24a, 15-276 Białystok, Poland.
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Oniszczuk
authors.affiliation: 2nd Department of Gynecology, Medical University of Lublin, Ulica Jaczewskiego 8, 20-954 Lublin, Poland.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Rechberger
mesh_terms: D000368:Aged; D001672:Biocompatible Materials / Q000009:adverse effects* / Q000627:therapeutic use; D004129:Dimethylpolysiloxanes / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007267:Injections; D008875:Middle Aged; D019736:Prostheses and Implants / Q000009:adverse effects*; D014025:Titanium / Q000009:adverse effects* / Q000627:therapeutic use; D016896:Treatment Outcome; D014521:Urethra / Q000503:physiopathology; D014550:Urinary Incontinence, Stress / Q000503:physiopathology / Q000628:therapy*
chemical_list: D001672:Biocompatible Materials; D004129:Dimethylpolysiloxanes; C000620953:urolastic; D014025:Titanium