Long-term efficacy and safety of a bioresorbable polycaprolactone-based injectable in female stress incontinence
Published: 4 April 2024
Abstract Views: 1923
PDF: 441
SUPPLEMENTARY MATERIAL: 282
SUPPLEMENTARY MATERIAL: 282
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.
Altmetrics
Downloads
Download data is not yet available.
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
Long-term efficacy and safety of a bioresorbable polycaprolactone-based injectable in female stress incontinence. (2024). 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.
Similar Articles
- F. Bernasconi, V. Napolitano, M. Primicerio, D. Lijoi, E. Leone, F. Armitano, M. Luerti, G.C. Sugliano, D. Vitobello, D. Riva, D. Gregori, SUI AND TVT IUS ND TVT SECURE SYSTEM: A PROSPECTIVE OBSERVATIONAL MULTICENTRIC STUDY. MORBIDITY AND SHORT-TERM PERCENTAGES OF SUCCESS , Urogynaecologia: Vol. 23 No. 3 (2009)
- Giorgio Gugliotta, Gloria Calagna, Roberta Granese, Giorgio Adile, Antonio Martorana, Biagio Adile, Trans-obturator tape technique and bladder injury. Cysto-urethroscopic management of intravesically-exposed sling , Urogynaecologia: Vol. 28 No. 1 (2014)
- S. Bandiera, G. Giunta, A. Aloisi, M. Arena, I. Iozza, M.G. Matarazzo, R. Morello, G. Raciti, F. Rapisarda, S.G. Vitale, A. Cianci, SURGICAL TREATMENT OF STRESS URINARY INCONTINENCE: A 3-YEAR FOLLOW-UP , Urogynaecologia: Vol. 22 No. 1 (2008)
- Maxime Marcelli, Gilles Karsenty, Jean-Philippe Estrade, Aubert Agostini, Ludovic Cravello, Gérard Serment, Marc Gamerre, Factors influencing sexual function in women with genital prolapse , Urogynaecologia: Vol. 25 No. 1 (2011)
- Nuria L. Rodríguez-Mias, Jordi Sabadell-García, Elena Suárez-Salvador, Antonio Gil-Moreno, Jose Luis Poza-Barrasus, Behaviour of urinary incontinence in the face of sacrocolpopexy , Urogynaecologia: Vol. 30 No. 1 (2017)
- V. Leanza, S. Dati, A.A. Cavallaro, M. Bologna, CORRELATION BETWEEN OVERACTIVE BLADDER (OAB) AND QUALITY OF LIFE (QoL). , Urogynaecologia: Vol. 22 No. 3 (2008)
- Aniefiok J. Umoiyoho, Aniekan M. Abasiattai, Okon E. Akaiso, Review of obstetric fistulas in a rural hospital in South-South Nigeria , Urogynaecologia: Vol. 25 No. 1 (2011)
- A. PISCHEDDA, F. PIROZZI FARINA, A. MATTANA, M. DERIU, G. SOLINAS, E. BERCOVICH, THE ROLE OF PELVIC FLOOR IMPAIRMENT AS A CONTRIBUTORY FACTOR TO URINARY INCONTINENCE IN PATIENTS WITH BLADDER INSTABILITY , Urogynaecologia: Vol. 18 No. 2 (2004)
- G. QUADRI, N. NATALE, C. SPREAFICO, C. BELLONI, D. BARISANI, J. LAHODNY, Intravesical prostaglandin e2 effectiveness in the prevention of urinary retention after transvaginal reconstruction of the pubo-cervical fascia and short arm sling according to Lahodny: a prospective randomized clinical trial , Urogynaecologia: Vol. 14 No. 1 (2000)
- Mário Maciel De Lima Junior, Elizângela Castelo Branco, Prevalence of female urinary incontinence in the state of Roraima, Brazil , Urogynaecologia: Vol. 30 No. 1 (2017)
You may also start an advanced similarity search for this article.