Urolastic—A New Bulking Agent for the Treatment of Women with Stress Urinary Incontinence: Outcome of 12 Months Follow Up

Abstract

Objective. To evaluate the efficacy and safety of the new injectable implant, Urolastic, in women with stress urinary incontinence (SUI) after 12-month followup. Materials and Methods. A prospective, cohort study included adult women with SUI. Patients were treated with Urolastic periurethral injections under local anaesthesia. The injection procedure was repeated after 6 weeks when indicated. Patients were evaluated for efficacy and safety parameters 6 weeks, 3 months, and 12 months after therapy. Results. Twenty women 56 (33–71) years old were included. Thirteen patients (65%) received one injection each (overall average of 2,1 mL); 7 patients (35%) received a second injection. Nineteen patients complete the 12-month followup. The mean Stamey incontinence grade significantly decreased from 1.9 at baseline to 0.4 at 12 months (visit IV) (P < 0.001). None of the patients were dry at baseline; 68% of them were dry at 12 months. The mean number of incontinence episodes significantly decreased from 6/day at baseline to 1.6/day at visit IV (P < 0.001). Reduction in pad weight went from 20.2 to 7.8 g at one year. The mean I-QoL score significantly increased from 51 at baseline to 76 at visit IV (P < 0.001). Six patients (30%) developed minor complications related to the injection procedure. Conclusions. Urolastic is effective and long-standing urethral bulking agent with moderate adverse events.

Treatment of Stress Urinary Incontinence in Neurological Patients With an Injectable Elastomer Prosthesis: Preliminary Results

“…Many promising agents have received preliminary approval from the U.S. Food and Drug Administration, before being subsequently withdrawn for this reason, such as autologous fat and Teflon [8]. In our experience, patients did not complain of the loss of efficacy, confirming the observations made by Zajda and Farag [4], who did not encounter migration in 19 patients over a 12-month follow-up period. He stated that Urolastic was effective and durable, which can be explained by the flexibility of the implant, which enables it to adapt itself to the shape of the local environment during injection, reducing the likelihood of migration.…”

“…The soft-cuff effect is potentially advantageous in these cases, as in the long term it might reduce the risk of erosion compared to artificial sphincters or Adjustable Continence Therapy (Medtronic, MN, Minnesota, USA) balloons, which have a more rigid composition. Urolastic hardens in situ into a flexible rubberlike plug, which adapts itself to the shape of the local environment [4]. We acknowledge that this advantage is only hypothetical for the moment, and should be confirmed by cystoscopy; nevertheless, none of the patients presented with clinical suspicion or signs of urethral erosion.…”

“…He stated that Urolastic was effective and durable, which can be explained by the flexibility of the implant, which enables it to adapt itself to the shape of the local environment during injection, reducing the likelihood of migration. Zajda and Farag [4] also stated in the same article that Urolastic is a biocompatible and nonbiodegradable agent, contributing to its long-term efficacy. In the present case series, we were able to confirm these findings in neurological patients.…”

“…Urolastic (Urogyn BV, Nijmegen, The Netherlands) is a new bulking agent, the efficacy of which has already been described in the management of female SUI [4], and is considered to be an effective and long-lasting treatment, with more than 1 year of efficacy. It is composed of a titanium-coated, nonbioabsorbable vinyl dimethyl polydimethylsiloxane elastomer.…”

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

“…A complication rate of 30% was reported by Zajda and Farag [6] in a similar group of 24 patients. In their study, there was a follow-up of one year.…”