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Urolastic — In-Situ Polymerizing Silicone Bulking Implant

Urolastic (PDMS-U) is a silicone implant that polymerizes after periurethral injection. It differs from Macroplastique, whose silicone particles are already formed before injection. Urolastic's clinical evidence includes observational studies reporting improvement, but also retention, pain, exposure, erosion, and removal of implanted material.[1][2]

Material and Procedure Boundaries​

The two-component material forms an elastomeric implant after mixing and injection. Its nondegradable design does not guarantee permanent continence or exclude displacement, exposure, or erosion.[3][2]

Published protocols generally used periurethral injections with an applicator, often without continuous cystoscopic visualization. Injection locations and volumes varied between studies; this page does not substitute an old study protocol for a current product-specific instruction for use.[4][2]

Small studies enrolled women with recurrent SUI, previous oncologic surgery, low flow, or neurologic voiding problems. These are study selection characteristics, not a verified current list of approved indications or proof that Urolastic is the preferred treatment for those conditions. In one such 20-patient cohort, eight developed a residual volume over 150 mL; it persisted in one patient who preferred catheter management.[5]

Efficacy: Keep the Endpoint and Denominator​

StudyDesign and populationFindings
Futyma 2015Uncontrolled multicenter study, 105 women, including 91 with recurrent SUIAt 12 months, objective success was reported in 59.3% of the recurrent-SUI group. Ten of 14 women with primary SUI improved.[6]
Futyma 201666 women with recurrent SUI; 24-month follow-upReported objective success was 32.7% and complete dryness 22.4% among those evaluated; corresponding intention-to-treat estimates were 24.2% and 16.7%. Success and dryness are distinct outcomes.[4]
Capobianco 2018Systematic review of five studies, follow-up 6–24 monthsObjective-success estimates pooled to 57% (95% CI 38–75%), with substantial heterogeneity (I²=82.3%). Reinjection pooled to 20%. This does not establish a durable cure rate or equivalence to another treatment.[7]
Casteleijn 2020Cross-sectional assessment: 110/202 eligible patients participated, 87 completed questionnaires; median 25 months44/87 were satisfied; 40/87 met the study's “subjective cure” definition of much/very much better, rather than necessarily dry. A negative cough stress test occurred in 35/74 tested; 74/87 still reported SUI symptoms.[2]

Comparison With Midurethral Sling​

The 2023 prospective nonrandomized comparison treated 131 women with Urolastic and 153 with midurethral sling. At the reported one-year assessment, subjective-cure outcomes favored sling (101/112 versus 40/87), as did negative cough stress tests (98/109 versus 58/92). The smaller assessment denominators, treatment selection, and residual confounding matter even after statistical adjustment.[8]

The same study reported lower mean total costs with Urolastic (€3,567 versus €6,688), not simply lower device acquisition cost. Cost-effectiveness conclusions differed by the quality-of-life measure used; those setting-specific findings do not establish a universal economic advantage.[8]

Safety and Removal​

In the 2020 cohort, recorded events included 24/110 retention, 16/110 pain, 16/110 dyspareunia, eight exposures, and six events classified as erosion. Twenty of 110 underwent excision. Missing participation, retrospective reporting, and incomplete baseline data limit estimates; the different follow-up groups do not constitute a longitudinal durability comparison.[2]

The 2016 recurrent-SUI series recorded complications in 17/66 (25.8%) and intravesical material in 3/66 (4.5%). Material in the bladder does not by itself establish whether the mechanism was migration, erosion, or initial misplacement.[4]

The 2021 systematic review identified an erosion rate as high as 24.6% in one Urolastic study. Its heterogeneous, largely noncomparative evidence cannot establish that Urolastic has the highest risk in every setting, or that another implant has zero future risk. Absence of reported erosion in the reviewed Bulkamid studies is not a guarantee.[9]

What the Learning-Curve Study Means​

A secondary analysis of 203 procedures by nine physicians assessed predefined safety targets. Among the five physicians with at least 20 procedures, two reached the specified competence thresholds, at procedure 20 and 40 respectively. Procedure count was not significantly associated with complications. This does not prove that training or technique is irrelevant: the authors noted variable techniques and possible retrospective underreporting.[10]

Current Use and Prior-Implant Care​

Urolastic remains listed on a European distributor's website, but a product listing does not establish an active CE certificate, an FDA approval, or the current country-specific instructions. A current manufacturer IFU and regulatory authorization were not verified in this review. Confirm both before considering use; historical publications do not establish present eligibility or procedural restrictions.[3]

In patients with prior Urolastic, assess leakage, emptying, pain, hematuria, infection, and exposure. Significant complications may require removal.[2]

See also: Bulkamid, Macroplastique, Coaptite, and Urethral Bulking Agents — Procedure.

References​

1. Hussain SM, Bray R. Urethral Bulking Agents for Female Stress Urinary Incontinence. Neurourology and Urodynamics. 2019;38(3):887-892. doi:10.1002/nau.23924

2. Casteleijn FM, Kowalik CR, Berends C, et al. Patients' Satisfaction and Safety of Bulk Injection Therapy Urolastic for Treatment of Stress Urinary Incontinence: A Cross-Sectional Study. Neurourology and Urodynamics. 2020;39(6):1753-1763. doi:10.1002/nau.24417

3. NeoMedic GmbH. Urolastic product information. Distributor product page. Accessed September 12, 2026.

4. Futyma K, Nowakowski Ł, Gałczyński K, Miotła P, Rechberger T. Nonabsorbable Urethral Bulking Agent — Clinical Effectiveness and Late Complications Rates in the Treatment of Recurrent Stress Urinary Incontinence After 2 Years of Follow-Up. European Journal of Obstetrics, Gynecology, and Reproductive Biology. 2016;207:68-72. doi:10.1016/j.ejogrb.2016.10.011

5. Kowalik CR, Casteleijn FM, van Eijndhoven HWF, Zwolsman SE, Roovers JWR. Results of an Innovative Bulking Agent in Patients With Stress Urinary Incontinence Who Are Not Optimal Candidates for Mid-Urethral Sling Surgery. Neurourology and Urodynamics. 2018;37(1):339-345. doi:10.1002/nau.23299

6. Futyma K, Miotła P, Gałczyński K, et al. An Open Multicenter Study of Clinical Efficacy and Safety of Urolastic, an Injectable Implant for the Treatment of Stress Urinary Incontinence: One-Year Observation. BioMed Research International. 2015;2015:851823. doi:10.1155/2015/851823

7. Capobianco G, Azzena A, Saderi L, et al. Urolastic®, a New Bulking Agent for Treatment of Stress Urinary Incontinence: A Systematic Review and Meta-Analysis. International Urogynecology Journal. 2018;29(9):1239-1247. doi:10.1007/s00192-018-3703-6

8. Casteleijn FM, de Vries AM, Tu LM, et al. Cost-Effectiveness of Urethral Bulking Polydimethylsiloxane-Urolastic® Compared With Mid-Urethral Sling Surgery for Stress Urinary Incontinence: A Two-Arm Cohort Study. BJOG. 2023;130(6):674-683. doi:10.1111/1471-0528.17396

9. Hoe V, Haller B, Yao HH, O'Connell HE. Urethral Bulking Agents for the Treatment of Stress Urinary Incontinence in Women: A Systematic Review. Neurourology and Urodynamics. 2021;40(6):1349-1388. doi:10.1002/nau.24696

10. Casteleijn F, Latul Y, van Eekelen R, Roovers JP. A Clinical Learning Curve Study of Polydimethylsiloxane Urolastic for Stress Urinary Incontinence: Does Safety Improve When Expertise Grow? Gynecologic and Obstetric Investigation. 2023;88(4):240-248. doi:10.1159/000530666