Effectiveness of bulking agents in managing stress and mixed urinary incontinence: a systematic review and meta-analysis

Authors

DOI:

https://doi.org/10.22141/2307-1257.13.4.2024.482

Keywords:

stress urinary incontinence, mixed urinary incontinence, urethral bulking agents, efficacy, safety, cure rates

Abstract

Stress urinary incontinence and stress-predominant mixed urinary incontinence are prevalent conditions that significantly impair quality of life, particularly among women. Urethral bulking agents have emerged as a non-surgical treatment option for patients who are hesitant to undergo surgical interventions. The aim of this systematic review and meta-analysis is to evaluate the efficacy and safety of various urethral bulking agents, specifically Bulkamid, Macroplastique, and Urolastic, in treating stress urinary incontinence and stress-predominant mixed urinary incontinence. The review encompasses 15 studies, including rando­mized controlled trials and cohort studies, with a total of 1,120 patients. The analysis focuses on cure and improvement rates, complications, and the risk of bias associated with the included studies. The fin­dings indicate that bulking agents demonstrate cure and improvement rates ranging from 70 to 80 %, with a pooled average of 75 %. Subgroup analyses reveal cure rates of 76 % for Bulkamid, 73 % for Urolastic, and 77 % for Macroplastique. Despite significant statistical heterogeneity, particularly for Bulkamid and Urolastic, the results suggest that these agents can serve as effective non-surgical options. The outcomes appear consistent across all continents included in this study, reinforcing their potential as reliable alternative glo­bally. Ho­wever, the review highlights the necessity for well-designed randomized controlled trials to further assess the long-term efficacy and safety of these treatments, ultimately aiming to optimize patient outcomes.

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References

Nitti VW. The prevalence of urinary incontinence. Rev Urol. 2001;3(Suppl 1):S2-6.

Viereck V, Bader W, Lobodasch K, Pauli F, Bentler R, Kölbl H. Guideline-Based Strategies in the Surgical Treatment of Female Urinary Incontinence: The New Gold Standard is Almost the Same as the Old One. Geburtshilfe Frauenheilkd. 2016 Aug;76(8):865-868. doi: 10.1055/s-0042-107079.

Corrado B, Giardulli B, Polito F, Aprea S, Lanzano M, Dodaro C. The Impact of Urinary Incontinence on Quality of Life: A Cross-Sectional Study in the Metropolitan City of Naples. Geriatrics (Basel). 2020 Nov 20;5(4):96. doi: 10.3390/geriatrics5040096.

American Urogynecologic Society (AUGS). Coding for Urethral Bulking. Silver Spring, MD: AUGS; 2018. 3 p.

Sikora M, Gamper M, Zivanovic I, et al. Current Treatment of Stress Urinary Incontinence by Bulking Agents and Laser Therapy-An Update. J Clin Med. 2024 Feb 28;13(5):1377. doi: 10.3390/jcm13051377.

Lemperle G, Lemperle SM. Injectable Bulking Agents for the Treatment of Stress Urinary Incontinence. SM Gerontol Geriatr Res. 2017;1(1):1-9. doi: 10.36876/smggr.1005.

Serati M, Mancini V, Balzarro M. Urethral bulking agents for the treatment of female stress urinary incontinence. Int Urogynecol J. 2020 Aug;31(8):1493-1494. doi: 10.1007/s00192-019-04221-3.

Ghoniem G, Farhan B, Chowdhury ML, Chen Y. Safety and efficacy of polydimethylsiloxane (Macroplastique®) in women with stress urinary incontinence: analysis of data from patients who completed three years follow-up. Int Urogynecol J. 2021 Oct;32(10):2835-2840. doi: 10.1007/s00192-021-04827-6.

Lemmon B, Cardozo L, Bray R, Cortes E. Retrospective analysis of the efficacy and safety of polyacrylamide hydrogel (Bulkamid®) peri-urethral bulking injection at the time of pelvic floor repair in women with pelvic organ prolapse and urodynamic stress incontinence. A pilot study. Continence. 2024 Jun;10:101221. doi: 10.1016/j.cont.2024.101221.

Hoe V, Haller B, Yao HH, O'Connell HE. Urethral bulking agents for the treatment of stress urinary incontinence in women: A systematic review. Neurourol Urodyn. 2021 Aug;40(6):1349-1388. doi: 10.1002/nau.24696.

Brosche T, Kuhn A, Lobodasch K, Sokol ER. Seven-year efficacy and safety outcomes of Bulkamid for the treatment of stress urinary incontinence. Neurourol Urodyn. 2021 Jan;40(1):502-508. doi: 10.1002/nau.24589.

Tan X, Li G, Li C, Kong C, Li H, Wu S. Animal models, treatment options, and biomaterials for female stress urinary incontinence. Front Bioeng Biotechnol. 2024 Feb;12:1414323. doi: 10.3389/fbioe.2024.1414323.

Fleischmann N, Chughtai B, Plair A, et al. Urethral Bulking. Urogynecology (Phila). 2024 Aug 1;30(8):667-682. doi: 10.1097/SPV.0000000000001548.

Sebesta EM, Dmochowski RR. Mixed Urinary Incontinence: Diagnosis and Management. OBM Geriatrics. 2023 Oct 5;07(04):1-22. doi: 10.21926/obm.geriatr.2304251.

Saraluck A, Chinthakanan O, Kijmanawat A, Aimjirakul K, Wattanayingcharoenchai R, Manonai J. Autologous platelet rich plasma (A-PRP) combined with pelvic floor muscle training for the treatment of female stress urinary incontinence (SUI): A randomized control clinical trial. Neurourol Urodyn. 2024 Feb;43(2):342-353. doi: 10.1002/nau.25365.

Lord LM, McGinnis C, Densmore C. Addressing the unique needs and quality of life issues for adults receiving long-term home enteral nutrition. Nutr Clin Pract. 2023 Apr;38(2):257-276. doi: 10.1002/ncp.10965.

Braga A, Caccia G, Papadia A, et al. Urethral bulking agents for the treatment of recurrent stress urinary incontinence: A systematic review and meta-analysis. Maturitas. 2022 Sep;163:28-37. doi: 10.1016/j.maturitas.2022.05.007.

Tunn R, Baessler K, Knüpfer S, Hampel C. Urinary incontinence and pelvic organ prolapse in women. Dtsch Arztebl Int. 2023 Feb 3;120(5):71-80. doi: 10.3238/arztebl.m2022.0406.

Gaddi A, Guaderrama N, Bassiouni N, Bebchuk J, Whitcomb EL. Repeat midurethral sling compared with urethral bulking for recurrent stress urinary incontinence. Obstet Gynecol. 2014 Jun;123(6):1207-1212. doi: 10.1097/AOG.0000000000000282.

Pai A, Al-Singary W. Durability, safety and efficacy of polyacrylamide hydrogel (Bulkamid(®)) in the management of stress and mixed urinary incontinence: three year follow up outcomes. Cent European J Urol. 2015;68(4):428-433. doi: 10.5173/ceju.2015.647.

Rosenfeld EC, Christie A, Bacsu CD, Zimmern PE. Macroplastique outcome in women with stress urinary incontinence secondary to intrinsic sphincteric deficiency. Urol Sci. 2016 Dec;27(4):258-262. doi: 10.1016/j.urols.2015.02.001.

De Vries AM, van Breda HMK, Fernandes JG, Venema PL, Heesakkers JPFA. Para-Urethral Injections with Urolastic® for Treatment of Female Stress Urinary Incontinence: Subjective Improvement and Safety. Urol Int. 2017;99(1):91-97. doi: 10.1159/000452450.

Zivanovic I, Rautenberg O, Lobodasch K, von Bünau G, Walser C, Viereck V. Urethral bulking for recurrent stress urinary incontinence after midurethral sling failure. Neurourol Urodyn. 2017 Mar;36(3):722-726. doi: 10.1002/nau.23007.

Rodríguez D, Carroll T, Alhalabi F, Carmel M, Zimmern PE. Outcomes of Macroplastique injections for stress urinary incontinence after suburethral sling removal. Neurourol Urodyn. 2020 Mar;39(3):994-1001. doi: 10.1002/nau.24321.

Serati M, Giammò A, Carone R, et al.; Italian Society of Urodynamics. Bulking agents for the treatment of recurrent stress urinary incontinence: a suitable option? Minerva Urol Nephrol. 2022 Dec;74(6):747-754. doi: 10.23736/S2724-6051.21.04269-5.

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 Res Int. 2015;2015:851823. doi: 10.1155/2015/851823.

Clark R, Welk B. The use of polyacrylamide hydrogel in the setting of failed female stress incontinence surgery. Can Urol Assoc J. 2018 Apr;12(4):95-97. doi: 10.5489/cuaj.4838.

Dray EV, Hall M, Covalschi D, Cameron AP. Can urethral bulking agents salvage failed slings? Urology. 2019 Feb;124:78-82. doi: 10.1016/j.urology.2018.09.019.

Daly CME, Mathew J, Aloyscious J, Hagen S, Tyagi V, Guerrero KL. Urethral bulking agents: a retrospective review of primary versus salvage procedure outcomes. World J Urol. 2021 Jun;39(6):2107-2112. doi: 10.1007/s00345-020-03413-7.

Long CY, Lin KL, Shen CR, et al. A pilot study: effectiveness of local injection of autologous platelet-rich plasma in treating women with stress urinary incontinence. Sci Rep. 2021 Jan 15;11(1):1584. doi: 10.1038/s41598-020-80598-2.

Serati M, Braga A, Scancarello C, et al. Does the polydimethylsiloxane urethral injection (Macroplastique®) improve sexual function in women, in fertile age, affected by stress urinary incontinence? Medicina (Kaunas). 2023 Mar 15;59(3):580. doi: 10.3390/medicina59030580.

Imrey PB. Limitations of meta-analyses of studies with high heterogeneity. JAMA Netw Open. 2020 Jan 3;3(1):e1919325. doi: 10.1001/jamanetworkopen.2019.19325.

Gandhi AP, Shamim MA, Padhi BK. Steps in undertaking meta-analysis and addressing heterogeneity in meta-analysis. Evidence. 2023;1(1):78-92. doi: 10.61505/evidence.2023.1.1.7.

Campanella L, Gabrielli G, Chiodo E, et al. Minimally Invasive Treatment of Stress Urinary Incontinence in Women: A Prospective Comparative Analysis between Bulking Agent and Single-Incision Sling. Healthcare (Basel). 2024 Mar 29;12(7):751. doi: 10.3390/healthcare12070751.

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Published

2025-01-09

How to Cite

Paramita, A. D., Ustadi, F. F., Susanto, J., Ansori, M. A., Kurniawati, E. M., & Setyo Hadi, T. H. (2025). Effectiveness of bulking agents in managing stress and mixed urinary incontinence: a systematic review and meta-analysis. KIDNEYS, 13(4), 261–271. https://doi.org/10.22141/2307-1257.13.4.2024.482

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Reviews