Urolastic®, a new bulking agent for treatment of stress urinary incontinence: a systematic review and meta-analysis

Capobianco, Giampiero; Azzena, A; Saderi, Laura; Dessole, Francesco; Dessole, Salvatore; Sotgiu, Giovanni

doi:10.1007/s00192-018-3703-6

Cited by 11 publications

(5 citation statements)

References 26 publications

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“…It's unique feature is that it polymerizes in situ into a uniform elastomer, remaining flexible and adapting itself to the environment. 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 …”

Section: Resultsmentioning

confidence: 99%

“…This is thought to reduce the risk of migration. 38,39 In a clinical trial in the Netherlands, 76-88% of the patients showed subjective improvement at 12-25 months follow-up. 40 In conclusion, although, there have been a number of studies conducted to look at the short-term efficacy, durability and safety of UBAs, in order to guide future practice, further comparative randomised trials involving a placebo or conservative treatment arm are required with long-term follow up.…”

Section: Discussionmentioning

confidence: 99%

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Urethral bulking agents for female stress urinary incontinence

Hussain

Bray

2019

Neurourology and Urodynamics

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Urethral bulking agents (UBAs) to treat stress urinary incontinence was first described in the 1930s, when paraffin was used to increase urethral resistance. Since then, several agents have been introduced to the market, with varying degrees of safety, efficacy, and durability. The agents currently available include calcium hydroxyl apatite (Coaptite®), carbon coated zirconium (Durasphere®); polydimethylsiloxane elastomer (Macroplastique®); and polyacrylamide hydrogel (Bulkamid®). The latest product, PDMS‐U (Urolastic ®) is a silicone gel that polymerizes when injected. The short term efficacy of UBAs are generally encouraging; however, longer follow up results show the success rates are reduced and many women will require a repeat treatment. This review looks at the currently available UBAs, application techniques, and the clinical data on their safety and efficacy.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Urethral bulking agents for female stress urinary incontinence

Hussain

Bray

2019

Neurourology and Urodynamics

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“…Currently marketed is a solid implant, Urolastic ® , which consists of a vinyldimethyl terminated polydimethylsiloxane polymer, tetrapropoxysilane cross-linking agent, platinum vinyltetramethyl siloxane complex catalyst and titanium dioxide radiopacifying agent 48. The material polymerizes in situ to form an elastomer, changing from a liquid to a solid state to form a cuff effect around the urethra 48. Urolastic ® is associated with vaginal erosion rates of up to 21.5%, many of which required implant excision 49…”

Section: Discussionmentioning

confidence: 99%

Particulate Versus Non-Particulate Bulking Agents In The Treatment Of Stress Urinary Incontinence

Chapple¹,

Dmochowski²

2019

RRU

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Stress urinary incontinence (SUI) has been treated surgically with the midurethral sling but in recent years, this option has come under scrutiny and the risk–benefit balance continues to be reviewed. The low-risk alternative for women with uncomplicated SUI is the bulking agent, which aims to achieve continence through coaptation of the urethra. Two classes of bulking agents can be identified: those made from solid microparticles in an absorbable liquid or gel carrier (particulate agents) and those comprising a homogenous gel (non-particulates) that resists absorption. Polydimethylsiloxane®, carbon-coated zirconium oxide®, calcium hydroxyapatite® and polyacrylate polyalcohol copolymer® are currently marketed particulate agents. With the exception of calcium hydroxyapatite, the particles are non-degradable. Each agent achieves its long-term bulking effect through reactive changes around the persisting particles while the carrier volume is lost. Bulkamid® is a non-particulate agent with the bulking effect resulting from the volume of gel injected. The lasting network of fine fibers formed by the host tissue anchors the gel in situ. Foreign-body granulomas, erosion and migration/material extrusion and loss of bulk have been observed in connection with the particle-based products. Bulkamid may be mechanistically less liable to these events; however, there are minimal data directly comparing the two types of bulking agent. The question of durability is inevitable based on their differing modes of action.

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“…Theoretically, these characteristics result in more durable cure rates as compared to the more hydrophilic bulking agents that tend to be absorbed over time. Single surgeon prospective cohort studies showed objective cure rates following PDMS-U varying from 33% up to 67% [8]. Overall complications of PDMS-U occurred in 24% of patients and included urinary retention, pain, haematuria, infection, urinary issues (frequency, urgency, incontinence), and erosion of the urethra/vaginal wall [9].…”

Section: Introductionmentioning

confidence: 99%

A Clinical Learning Curve Study of Polydimethylsiloxane Urolastic for Stress Urinary Incontinence: Does Safety Improve when Expertise Grow?

Casteleijn¹,

Latul²,

Eekelen³

et al. 2023

Gynecol Obstet Invest

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Objectives: The aim of the study was to characterize the learning curve of bulk injection therapy polydimethylsiloxane Urolastic (PDMS-U) for stress urinary incontinence. Design: Secondary analysis from three clinical studies on efficacy and safety outcomes of PDMS-U was performed. Participants/Materials, Setting, Methods: PDMS-U-certified physicians who performed ≥4 procedures were included. The primary outcome was the number of PDMS-U procedures needed to achieve acceptable failure rates for “complications overall,” “urinary retention,” and “excision,” using the LC-CUSUM method. For the primary outcome, physicians who performed ≥20 procedures were used. For the secondary outcome, logistic and linear regression analysis was used to assess the relationship between number of procedures, complications (complications overall, urinary retention, pain, exposure, excision of PDSM-U), and duration of treatment. Results: In total, 203 PDMS-U procedures were performed by nine physicians. Five physicians were used for the primary outcome. For “complications overall,” “urinary retention,” and “excision,” two physicians reached a level of competence: one at procedure 20 and one at procedure 40. The secondary outcome showed no statistically significant association between procedure number and complications. There was a statistically significant increase in the duration of treatment with more physician experience (mean difference 0.83 min per 10 additional procedures, 95% CI: 0.16–1.48). Limitations: One limitation is that retrospectively collected data might have underreported the number of complications. Secondly, there was variation in the way the technique was applied between physicians. Conclusions: Physicians’ experience in the PDMS-U procedure did not influence safety outcomes. There was large inter-physician variability and most physicians did not reach acceptable failure rates. There was no relationship between PDMS-U complications and the number of performed procedures.

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Urolastic®, a new bulking agent for treatment of stress urinary incontinence: a systematic review and meta-analysis

Abstract: Urolastic® showed effectiveness in patients with SUI during a follow-up period of 6-24 months.

Cited by 11 publications

References 26 publications

Urethral bulking agents for female stress urinary incontinence

Urethral bulking agents for female stress urinary incontinence

<p>Particulate Versus Non-Particulate Bulking Agents In The Treatment Of Stress Urinary Incontinence</p>

A Clinical Learning Curve Study of Polydimethylsiloxane Urolastic for Stress Urinary Incontinence: Does Safety Improve when Expertise Grow?

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