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.

Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid‐urethral sling surgery

“…Two studies in women with predominantly primary SUI showed an overall success (defined as a decrease in the Stamey Score by 1 grade compared to the baseline continence status) of 89% after 12 months follow up and 66% after 24 months follow up, whereas respectively 68% and 45% of patients were dry after 12 and 24 months . Two reports on women with mostly recurrent SUI reported that 59% and 22% of patients were completely dry after 12 and 24 months of follow up respectively …”

How cure rates drive patients' preference for urethral bulking agent or mid‐urethral sling surgery as therapy for stress urinary incontinence

“…Randomized trials comparing UBA with MUS surgery are needed to determine if UBA treatment achieves cure rates of 79% or higher. Cohort studies of bulking agent Urolastic report results lower to this threshold with subjective and objective cure rates of 56% to 68% and 59% to 65%, respectively, after 6‐ and 12‐month follow‐up . A systematic review of other bulking agents show on the other hand subjective and objective success rates up to 89% and 73% …”

“…Cohort studies of bulking agent Urolastic report results lower to this threshold with subjective and objective cure rates of 56% to 68% and 59% to 65%, respectively, after 6-and 12-month follow-up. 4,7,24 A systematic review of other bulking agents show on the other hand subjective and objective success rates up to 89% and 73%. 8 There is no worldwide consensus about the exact place of UBA in current treatment protocols.…”

“…With a low complication rate of 0% to 5.7%, the safety profile seems to be better than MUS surgery. 4,5 Variable clinical success rates of UBA of 50% to 89% after 1-year follow-up are reported. [6][7][8] The National Institute for Health and Care Excellence and the European Association of Urology (EAU) guidelines recommend UBA to be used for short-term management of SUI if conservative management has failed.…”

Para-Urethral Injections with Urolastic® for Treatment of Female Stress Urinary Incontinence: Subjective Improvement and Safety

“…Implants that caused pain were removed with an effortless procedure, using a small vaginal incision. The second study published is from Futyma et al [7] , who treated a group of 105 patients, 91 of whom were recurrent patients. A complication rate of 16.2% was reported and no serious adverse events were mentioned.…”