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

Abstract

Introduction: 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®. Materials and 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.

Complications of urethral bulking therapy for female stress urinary incontinence

“…de Vries et al could not demonstrate any significant correlation between the volume of bulk, the number of previous procedures or age and the complications observed in their study assessing the subjective improvement and safety of Urolastic™‐based UBT. Furthermore, the distributions of complications were not significantly different between General Hospitals and Tertiary Referral centers in terms of their grading according to the Clavien‐Dindo system …”

“…The objective outcome after mid‐urethral sling surgery might be better, however a meta‐analysis in 2015 has shown that the subjective outcomes after UBT do not differ significantly from other surgical treatment options . This may mean that; “less‐invasiveness” might balance for lower efficacy in a selected group of patients …”

“…13 This may mean that; "less-invasiveness" might balance for lower efficacy in a selected group of patients. 14 UBT should be accepted as a staged treatment rather than a single intervention after which urinary incontinence will be eliminated completely since, multiple injections and/or further surgical interventions may be required to achieve continence. 15 It has also been shown that; prior UBT seems not to negatively influence outcomes if future anti-incontinence surgery is needed.…”

Urethral bulking agents for female stress urinary incontinence

“…This is thought to reduce the risk of migration . In a clinical trial in the Netherlands, 76‐88% of the patients showed subjective improvement at 12‐25 months follow‐up …”

Mini-Sling Ophira at 8 Years Follow-Up: Does It Sustain Results?

“…Patients with recurrent urinary incontinence have worse outcomes and a higher likelihood of failure in any subsequent anti-incontinence technique, mostly in the long term, and fibrotic tissue around urethra can limit its mobility and prevent sling to achieve ideal support to the urethra [16][17][18][19][20][21]. Although SIMS is a very heterogeneous group, worse long-term results among patients with previous surgeries support the hypothesis that longstanding success could depend on the grade and pattern of interaction between the sling and suburethral support tissues [22].…”