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Urethral Bulking Agents for the management of stress urinary incontinence: An Overview

Dr. Leon N. PlowrightMD, FACOG, FACS, UROS<br>
Dr. Leon N. PlowrightMD, FACOG, FACS, UROS
Assistant Professor of Obstetrics and Gynecology University of Florida-Jacksonvillle Medical Directorm UF Health Women’s Specialists – Elizabeth G. Means

Stress urinary incontinence (SUI) is a highly prevalent condition affecting a significant proportion of women across the lifespan. The gold standard treatment is the midurethral sling, which provides extrinsic support to stabilize the urethra and restore continence. While effective, slings are associated with potential complications, including mesh exposure, voiding dysfunction, and pelvic pain.

Urethral bulking agents (UBAs) offer a minimally invasive alternative, developed on the principle of enhancing intrinsic urethral coaptation to reduce leakage. Since their introduction in the 1970s, UBAs have evolved significantly. Early materials like polytetrafluoroethylene (Teflon) were abandoned due to safety concerns such as particle migration. In the 1990s, bovine collagen (Contigen) became the first FDA-approved agent but had limited durability due to rapid resorption.

Modern UBAs include carbon-coated beads (Durasphere), calcium hydroxylapatite (Coaptite), silicone-based Macroplastique, polyacrylamide hydrogel (Bulkamid), and silicone elastomer-based Urolastic. These agents offer improved biocompatibility and reduced inflammatory response. Bulkamid has gained popularity due to its excellent safety profile and favorable mid- to long-term outcomes.

Agent

Composition

Particulate?

Biocompatability

Durability

Long-term Success Rate

Bulk amid

Polyacrylamide hydrogel

No

Excellent – minimal fibrosis

Moderate to good (up to 5+ years)

57–70% (up to 5 years)

Macroplastique

Silicone particles in carrier gel

Yes

Good, but risk of granulomas

Moderate

30–50% (2–3 years)

Coaptite

Calcium hydroxylapatite

Yes

Good, some foreign body response

Moderate

25–45% (2 years)

Durasphere

Carbon-coated zirconium beads

Yes

Fair – more inflammatory response

Moderate

20–40% (1–2 years)

Contigen

Bovine collagen

No

Moderate – resorbed over time

Poor (reabsorbed quickly)

<25% (1 year)

Urolastic

Silicone elastomer-based polymer

No

Good – forms cohesive, stable implant

Moderate to good (2–3+ years)

40–65% (2–3 years)

While UBAs do not carry the same risk profile as synthetic slings, they are not without complications. Most adverse events are minor, including transient urinary retention, urinary tract infections, and hematuria. Rare but serious complications such as urethral erosion, abscess formation, or material migration have been reported. Outcomes depend heavily on patient selection and managing expectations.

UBAs are appropriate for a variety of clinical scenarios, including:

  • Patients who are poor surgical candidates.
  • Those wishing to avoid mesh.
  • Smokers unwilling to cease smoking.
  • Recurrent SUI after prior sling procedures.
  • Stress-predominant mixed incontinence.
  • Preference for a minimally invasive treatment of occult incontinence.
  • Previously irradiated patients with limited surgical options.
  • Women with high BMI in whom sling placement poses technical challenges.

Recent meta-analyses support the use of modern UBAs in selected populations. A 2021 review comparing UBAs to surgical options found that while slings offered higher subjective cure rates, UBAs demonstrated comparable safety with fewer perioperative complications. A 2024 analysis reported a 75% average cure and improvement rate across Bulkamid, Macroplastique, and Urolastic.

Although long-term durability is lower than that of slings or autologous fascial slings, urethral bulking remains a viable option for patients prioritizing minimally invasive care. Repeat injections may be required to sustain continence, and shared decision-making is key. UBAs continue to play a valuable role in the tailored management of SUI, especially in patients seeking lower-risk or non-surgical alternatives.

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References:

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4.      Aboseif SR, Waxman SW, Herschorn S, et al. The use of calcium hydroxylapatite for treating female stress urinary incontinence: results of a multicenter, randomized, controlled clinical trial. J Urol. 2007;177(3):1025–1029. doi:10.1016/j.juro.2006.10.046

5.      Lose G, Mouritsen L, Nielsen JB, et al. A randomized, double-blind, placebo-controlled study investigating the efficacy of polyacrylamide hydrogel (Bulkamid) for treatment of female stress and mixed urinary incontinence. Int Urogynecol J. 2010;21(12):1471–1478. doi:10.1007/s00192-010-1202-1

6.      Chapple CR, Toozs-Hobson P, Cardozo L, et al. Long-term safety and efficacy of polyacrylamide hydrogel (Bulkamid) for female stress urinary incontinence: a 5-year study. Neurourol Urodyn. 2021;40(2):588–595. doi:10.1002/nau.24611

7.      Mohr S, Ismail SI, Rosati M, et al. Effectiveness and safety of bulking agents versus surgical methods in women with stress urinary incontinence: a systematic review and meta-analysis. Neurourol Urodyn. 2021;40(4):987–1000. doi:10.1002/nau.24706

8.      Mohr S, Ismail SI, Lim CP, et al. Effectiveness of bulking agents in managing stress and mixed urinary incontinence: a systematic review and meta-analysis. Int Urogynecol J. 2024. Advance online publication. doi:10.1007/s00192-024-05791-3

9.      Ghoniem G, Corcos J, Comiter C, et al. The role of urethral bulking agents in the treatment of stress urinary incontinence: a consensus statement. Neurourol Urodyn. 2010;29(3):552–558. doi:10.1002/nau.20809

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11.  Kociszewski J, Rautenberg O, Eberhard J, et al. Urolastic: A new agent for treatment of stress urinary incontinence—a clinical pilot study. Neurourol Urodyn. 2012;31(3):421–424. doi:10.1002/nau.21214

12.  ACOG Practice Bulletin No. 155. Urinary incontinence in women. Obstet Gynecol. 2015;126(5):e66–e81. doi:10.1097/AOG.0000000000001142