https://doi.org/10.4081/uij.2024.324
Long-term efficacy and safety of a bioresorbable polycaprolactone-based injectable in female stress incontinence
Submitted: 27 January 2024
Accepted: 15 March 2024
Published: 4 April 2024
Accepted: 15 March 2024
Abstract Views: 1009
PDF: 210
SUPPLEMENTARY MATERIAL: 96
SUPPLEMENTARY MATERIAL: 96
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.
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 polycaprolactone (PCL)-based bulking agent was evaluated for safety and efficacy in female patients with mild to moderate stress urinary incontinence (SUI) who attempted and failed prior pelvic floor muscle training. A total of 44 adult female subjects with mild or moderate SUI (median age 60 and 57, respectively) were treated by transurethral sub-mucosal injection. Safety was evaluated at 6-, 12-, and 24-month follow-up visits. Efficacy was assessed at the same intervals with the Stamey grading system (SGS). SGS improvement was shown in both the mild and moderate SUI groups. At 24 months, most participants were continent: 78.1% in the mild SUI group and 66.7% in the moderate SUI group. All participants in the moderate SUI group showed an improvement in the SGS grade, and most participants were continent. The study shows that the PCL-based bioresorbable bulking agent treatment seems to be a safe and effective treatment option for women with mild to moderate SUI who attempted and failed prior pelvic floor exercises.
Blaivas JG, Purohit RS, Benedon MS, et al. Safety considerations for synthetic sling surgery. Nat Rev Urol 2015;12:481-509.
DOI: https://doi.org/10.1038/nrurol.2015.183
Dwyer L, Weaver E, Rajai A, et al. “Voice your choice”: a study of women’s choice of surgery for primary stress urinary incontinence. Int Urogynecol J 2020;31:769-77.
DOI: https://doi.org/10.1007/s00192-019-04202-6
Davis NF, Kheradmand F, Creagh T. Injectable biomaterials for the treatment of stress urinary incontinence: their potential and pitfalls as urethral bulking agents. Int Urogynecol J 2013;24:913-9.
DOI: https://doi.org/10.1007/s00192-012-2011-9
Rovner ES, Wein AJ. Treatment options for stress urinary incontinence. Rev Urol 2004;6:S29-47.
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
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. Plast Reconstr 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
Mojsović A, Koldewijn E. A retrospective analysis of 47 procedures using a bioresorbable polycaprolactone based injectable for the treatment of mild to moderate stress urinary incontinence in adult females. UIJ 2022;34(1).
DOI: https://doi.org/10.4081/uij.2022.283
Koldewijn EL, Oerlemans DJAJ, Beulens A, et al. Treatment of mild to moderate stress urinary incontinence with a novel polycaprolactone-based bioresorbable urethral bulking agent. Continence 2022;2:100342.
DOI: https://doi.org/10.1016/j.cont.2022.100342
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
Nicolau PJ, Marijnissen-Hofsté J. Neocollagenesis after injection of a polycaprolactone based dermal filler in a rabbit. Eur J Aesthetic Med Dermatol 2013;3:19-26.
Ryu JG, Yu SH, Jeong SH, et al. Transobturator tape for female stress urinary incontinence: preoperative valsalva leak point pressure is not related to cure rate or quality of life improvement. Korean J Urol 2014;55:265-9.
DOI: https://doi.org/10.4111/kju.2014.55.4.265
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 Urodyn 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
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 Obstet Gynecol 2011;205:498.e1-6.
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
Lin SL, Christen MO. Polycaprolactone-based dermal filler complications: a retrospective study of 1111 treatments. J Cosmet Dermatol 2020;19:1907-14.
DOI: https://doi.org/10.1111/jocd.13518
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 Aesthet 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
How to Cite
Mojsović, A., Beulens, A. J., & Koldewijn, E. L. (2024). Long-term efficacy and safety of a bioresorbable polycaprolactone-based injectable in female stress incontinence. Urogynaecologia, 36(1). https://doi.org/10.4081/uij.2024.324
Copyright (c) 2024 the Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
An Open Access Publication is one that meets the following two conditions:
- the author(s) and copyright holder(s) grant(s) to all users a free, irrevocable, worldwide, perpetual right of access to, and a license to copy, use, distribute, transmit and display the work publicly and to make and distribute derivative works, in any digital medium for any responsible purpose, subject to proper attribution of authorship, as well as the right to make small numbers of printed copies for their personal use.
- a complete version of the work and all supplemental materials, including a copy of the permission as stated above, in a suitable standard electronic format is deposited immediately upon initial publication in at least one online repository that is supported by an academic institution, scholarly society, government agency, or other well-established organization that seeks to enable open access, unrestricted distribution, interoperability, and long-term archiving.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work.
Similar Articles
- A. Albiero, A. Gazzoni, S. Giudici, S. Poggi, L. Fedele, EVALUATION OF EFFICACY OF DIFFERENT SURGICAL PROCEDURES IN THE TREATMENT OF SUI AND GENITAL PROLAPSE , Urogynaecologia: Vol. 15 No. 3 (2001)
- V. LEANZA, M. BOLOGNA, N. GASBARRO, TENSION-FREE TECHNIQUES IN UROGYNAECOLOGICAL SURGERY , Urogynaecologia: Vol. 19 No. 2-3 (2005)
- F. Magatti, P.L. Sirtori, C. Rumi, C. Belloni, TVT PROCEDURE FOR THE TREATMENT OF SUI: OUR EXPERIENCE , Urogynaecologia: Vol. 16 No. 1 (2002)
- S. Bandiera, G. Raciti, A. Aloisi, M. Arena, R. Giordano, G. Giunta, M.G. Matarazzo, R. Morello, F. Rapisarda, S.G. Vitale, A. Cianci, DOUBLE TRANSOBTURATOR APPROACH TO TREATING CYSTOCELE , Urogynaecologia: Vol. 22 No. 3 (2008)
- Stephanie W. Zuo, Jaden R. Kohn, Chi Chiung Grace Chen, Laura Tellechea, Harley Roberts, Ilir Agalliu, Ava Leegant, Nitya Abraham, Melissa Laudano, Assessing frailty in urogynecology patients: a comparative analysis of the Edmonton frail scale and pelvic floor symptom severity , Urogynaecologia: Vol. 35 No. 1 (2023)
- Munir'deen A. Ijaiya, Hadijat O. Raji, Treatment of pelvic organ prolapse , Urogynaecologia: Vol. 26 No. 1 (2012)
- J. BECO, J. MOUCHEL, PERINEOLOGY: A NEW AREA , Urogynaecologia: Vol. 17 No. 2 (2003)
- Gabriela Marini, Angélica M. Pascon Barbosa, Débora C. Damasceno, Selma M. Michelin Matheus, Rodrigo de Aquino Castro, Manoel João B. Castello Girão, Marilza V. Cunha Rudge, Morphological changes in the fast vs slow fiber profiles of the urethras of diabetic pregnant rats , Urogynaecologia: Vol. 25 No. 1 (2011)
- Thibault Thubert, Yohann Dabi, Anne Sophie Boudy, Marion Joubert, Christophe Vaessen, Emmanuel Chartier-Kastler, Jean-Pierre Lefranc, Morgan Rouprêt, Comparison of functional outcomes after robot-assisted laparoscopic sacrocolpopexy in women with a BMI below and above 30 , Urogynaecologia: Vol. 30 No. 1 (2017)
- M. Tamburello, V. Farruggia, S.M. Rubino, TWO CASES OF BLADDER PROLENE® TAPE EXPOSURE AFTER TVT PROCEDURE , Urogynaecologia: Vol. 16 No. 1 (2002)
You may also start an advanced similarity search for this article.