Para-Urethral Injections with Urolastic® for Treatment of Female Stress Urinary Incontinence: Subjective Improvement and Safety.
BACKGROUND
Female stress urinary incontinence (SUI) is often treated surgically. Urethral bulking agents are a minimally invasive alternative, especially in patients suffering from intrinsic sphincter deficiency, but often with limited long-term efficacy. Urolastic® is a non-deformable, non-resorbable silicone elastomer that is used as an injectable. Its properties might result in a more durable response after injection. If this durability factor can be combined with a low complication rate, this can become a useful treatment option. We therefore assessed the subjective improvement and safety after treatment with Urolastic®.


METHODS
In 2 Dutch hospitals, 65 patients were treated with Urolastic®. The subjective improvement was assessed and the medical charts were reviewed for complications that appeared during the follow-up period. The complications were classified using the Clavien-Dindo classification.


RESULTS
We found that 76-88% of the patients showed subjective improvement at 12-25 months follow-up. The rate of improvement experienced was 50-70%. The rate of complications classified as Clavien-Dindo >II was 24-33%. The 12 patients with 75-100% subjective improvement after 2 months, showed 85% improvement after a median of 25 months.


CONCLUSIONS
With careful patient selection, Urolastic® seems to be a safe, durable and effective treatment option for female SUI.
Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands.
Allert M
AM
de Vries
Hendrikje M K
HMK
van Breda
Jimmy G
JG
Fernandes
Pieter L
PL
Venema
John P F A
JPFA
Heesakkers
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004129:Dimethylpolysiloxanes / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007267:Injections; D008875:Middle Aged; D009426:Netherlands; D017060:Patient Satisfaction; D018579:Patient Selection; D020127:Recovery of Function; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D014025:Titanium / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014521:Urethra / Q000503:physiopathology*; D014549:Urinary Incontinence / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D055815:Young Adult
D004129:Dimethylpolysiloxanes; C000620953:urolastic; D014025:Titanium
Complications; Female stress urinary incontinence; Injectable; Urethral bulking agent; Urolastic