Treatment of mild to moderate stress urinary incontinence with a novel polycaprolactonebased bioresorbable urethral bulking agent

Submitted: 15 February 2022
Accepted: 13 May 2022
Published: 23 May 2022
Abstract Views: 1575
PDF: 309
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Authors

A fully bioresorbable polycaprolactonebased bioresorbable bulking agent was evaluated for safety and efficacy in female patients with mild to moderate stress urinary incontinence who attempted and failed prior pelvic floor muscle training. Fifty female subjects were treated by transurethral sub-mucosal injection. Safety was evaluated over a 24-monts follow-up period. At the 12-months visit, a cystoscopy was performed for visual inspection of the injected area. Efficacy was assessed with the same intervals with the Stamey Grading System (SGS) among others. Only 6/50 subjects reported transient mild adverse events. The results show for the SGS grade more than 55% of the participants had an improvement in SGS grade, 40% of whom were cured within the first 12 months after treatment. During the second year of follow- up the effect seems to falter with an improvement of 50% of the subjects of whom 25% were cured. The results of the study suggest that treatment of mild-tomoderate stress urinary incontinence with a bioresorbable PCL-based bulking agent is a safe and effective alternative to permanent bulking agents and intermediate treatment option before the use of the permanent midurethral sling.

Dimensions

Altmetric

PlumX Metrics

Downloads

Download data is not yet available.

Citations

Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol 2004;6:29–47.
Lukacz ES, Santiago-Lastra Y, Albo ME, Brubaker L. Urinary incontinence in women a review. JAMA 2017;318:1592–604. DOI: https://doi.org/10.1001/jama.2017.12137
Blaivas JG, Purohit RS, Benedon MS, et al. Safety considerations for synthetic sling surgery. Nat Rev Urol 20151;2:481–509. DOI: https://doi.org/10.1038/nrurol.2015.183
Davis NF, Kheradmand F, Creagh T. Injectable biomaterials for the treatment of stress urinary incontinence: their potential and pitfalls as urethral bulking agents. Int Urogyn J 2013;24:913–9. DOI: https://doi.org/10.1007/s00192-012-2011-9
Laeschke K. Biocompatibility of microparticles into soft tissue fillers. Semin Cutan Med Surg 2004;23:214–7. DOI: https://doi.org/10.1016/j.sder.2004.09.005
Nicolau PJ. Long-lasting and permanent fillers: biomaterial influence over host tissue response. Plastic Reconstruct Surg 2007;119:2271–86. DOI: https://doi.org/10.1097/01.prs.0000260710.30934.a1
Morhenn VB, Lemperle G, Gallo RL. Phagocytosis of different particulate dermal filler substances by human macrophages and skin cells. Dermatol Surg 2002;28:484–90. DOI: https://doi.org/10.1046/j.1524-4725.2002.01273.x
Galadari H, van Abel D, al Nuami K, et al. A randomized, prospective, blinded, split-face, single-center study comparing polycaprolactone to hyaluronic acid for treatment of nasolabial folds. J Cosmetic Dermatol 2015;14:27–32. DOI: https://doi.org/10.1111/jocd.12126
Moers-Carpi MM, Sherwood S. Polycaprolactone for the correction of nasolabial folds: a 24-month, prospective, randomized, controlled clinical trial. Dermatol Surg 2013;39:457–63. DOI: https://doi.org/10.1111/dsu.12054
Figueiredo VM. A five-patient prospective pilot study of a polycaprolactone based dermal filler for hand rejuvenation. J Cosmetic Dermatol 2013;12:73–7. DOI: https://doi.org/10.1111/jocd.12020
Woodruff MA, Hutmacher DW. The return of a forgotten polymer—Polycaprolactone in the 21st century. Progress Polymer Sci 2010;35:1217–56. DOI: https://doi.org/10.1016/j.progpolymsci.2010.04.002
Middleton JC, Tipton AJ. Synthetic biodegradable polymers as orthopedic devices. Biomaterials 2000;21:2335–46. DOI: https://doi.org/10.1016/S0142-9612(00)00101-0
Gunatillake PA, Adhikari R, Gadegaard N. Biodegradable synthetic polymers for tissue engineering. Eur Cells Mat 2003;5:1–16. DOI: https://doi.org/10.22203/eCM.v005a01
Hutmacher D, Hürzeler MB, Schliephake H. A Review of material properties of biodegradable and bioresorbable polymers and devices for GTR and GBR. Applications 1996;11:667–78.
Sinha VR, Bansal K, Kaushik R, et al. Poly-epsilon-caprolactone microspheres and nanospheres: an overview. Int J Pharm 2004;278:1–23. DOI: https://doi.org/10.1016/j.ijpharm.2004.01.044
Falcone SJ, Doerfler AM, Berg RA. Novel synthetic dermal fillers based on sodium carboxymethylcellulose: comparison with crosslinked hyaluronic acid-based dermal fillers. Dermatol Surg 2007;33:S136-43. DOI: https://doi.org/10.1111/j.1524-4725.2007.33353.x
Turaev AS. Dependence of the biodegradability of carboxymethylcellulose on its supermolecular structure and molecular parameters. Chem Natural Comp 1995;31:254–9. DOI: https://doi.org/10.1007/BF01170220
Zopf DA, Hollister SJ, Nelson ME, et al. Bioresorbable airway splint created with a three-dimensional printer. New Engl J Med 2013;368:2043–5. DOI: https://doi.org/10.1056/NEJMc1206319
Kim JA, van Abel D. Neocollagenesis in human tissue injected with a polycaprolactone-based dermal filler. J Cosmet Laser Ther 2015;17:99–101. DOI: https://doi.org/10.3109/14764172.2014.968586
Christen MO, Vercesi F. Polycaprolactone: How a well-known and futuristic polymer has become an innovative collagen-stimulator in esthetics. Clin Cosmet Investig Dermatol 2020;13:31–48. DOI: https://doi.org/10.2147/CCID.S229054
Klovning A, Avery K, Sandvik H, Hunskaar S. Comparison of two questionnaires for assessing the severity of urinary incontinence: The ICIQ-UI SF versus the incontinence severity index. Neurourol Urodynam 2009;28:411–5. DOI: https://doi.org/10.1002/nau.20674
World Medical Association. World Medical Association declaration of Helsinki: Ethical principles for medical research involving human subjects. World Medical Association, 2018. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
Brubaker L, Norton PA, Albo ME, et al. Adverse events over two years after retropubic or transobturator midurethral sling surgery: Findings from the Trial of Midurethral Slings (TOMUS) study. Am J Obst Gynecol 2011;205:498.e1-498.e6. DOI: https://doi.org/10.1016/j.ajog.2011.07.011
Lavelle ES, Zyczynski HM. Stress urinary incontinence: Comparative efficacy trials. Obstet Gynecol Clin North Am 2016;43:45-57. DOI: https://doi.org/10.1016/j.ogc.2015.10.009
Kowalik CR, Casteleijn FM, van Eijndhoven HWF, et al. Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid-urethral sling surgery. Neurourol Urodynam 2018;37:339–45. DOI: https://doi.org/10.1002/nau.23299
Siddiqui ZA, Abboudi H, Crawford R, Shah S. Intraurethral bulking agents for the management of female stress urinary incontinence: a systematic review. Int Urogynecol J 2017;28:1275–84. DOI: https://doi.org/10.1007/s00192-017-3278-7
Zajda J, Farag F. Urolastic-a new bulking agent for the treatment of women with stress urinary incontinence: outcome of 12 months follow up. Adv Urol 2013;2013:724082. DOI: https://doi.org/10.1155/2013/724082
Haneke E. Managing complications of fillers: rare and not-so-rare. J Cutan Aesthetic Surg 2015;8:198–210. DOI: https://doi.org/10.4103/0974-2077.172191
Wollina U, Goldman A. Dermal fillers: facts and controversies. Clin Dermatol 2013;31:731–6. DOI: https://doi.org/10.1016/j.clindermatol.2013.05.010
Serati M, Soligo M, Braga A, et al. Efficacy and safety of polydimethylsiloxane injection (Macroplastique ®) for the treatment of female stress urinary incontinence: results of a series of 85 patients with ≥3 years of follow-up. BJU Int 2019;123:353–9. DOI: https://doi.org/10.1111/bju.14550
Elmelund M, Sokol ER, Karram MM, et al. Patient characteristics that may influence the effect of urethral injection therapy for female stress urinary incontinence. J Urol 2019;202:125–30. DOI: https://doi.org/10.1097/JU.0000000000000176
Kmietowicz Z. Use mesh implants for stress urinary incontinence only as last resort, says NICE. BMJ 2018;363:k4242. DOI: https://doi.org/10.1136/bmj.k4242
Ong HL, Sokolova I, Bekarma H, et al. Development, validation and initial evaluation of patient-decision aid (SUI-PDA©) for women considering stress urinary incontinence surgery. Int Urogynecol J 2019;30:2013–22. DOI: https://doi.org/10.1007/s00192-019-04047-z

How to Cite

Koldewijn, E. L., Oerlemans, D. J., Beulens, A., de Wildt, M. J., Vandoninck, V., & De Wachter, S. . (2022). Treatment of mild to moderate stress urinary incontinence with a novel polycaprolactonebased bioresorbable urethral bulking agent. Urogynaecologia, 34(1). https://doi.org/10.4081/uij.2022.287