Background: Urinary incontinence mainly affects women regardless of age and, as it affects their quality of life, influences work, sex life and independence for activities of daily living. The treatment of stress urinary incontinence including urethral volume injection therapy can provide an intermediate option over non-surgical and surgical therapies. One of the mechanisms for stress continence depends on the effective coaptation of the urethra during the increase in intra-abdominal pressure. The bulking agents can be injected transurethral or periurethral retrogradely, using direct vision from a cystoscope. Purpose: To evaluate the feasibility and preliminary outcome performance of the bacterial polysaccharide gel used as biological bulking agent applied in female patients with stress urinary incontinence. Methods: A prospective clinical pilot study was performed, in a single institution, including female patients who were admitted to the urologic outpatient clinic with Stress Urinary Incontinence (SUI) without previous treatments and they were selected and underwent bulking agent procedure. The evaluation was performed at the time of enrollment and 6 months after treatment. The primary outcome was Quality of Life (QOL) using the ICIQ-SF Questionnaire. The amount of urine leakage measured by the 1-HOUR PAD-TEST was the second outcome. Results: Fifteen women (with an average age of 53 years) were submitted to the application of bacterial cellulose gel and she was analyzed. Only two patients presented unchanged incontinence. The study considered as primary outcome the improvement or disappearance of symptoms after six months of intervention. Post-intervention Quality of Life (QOL) questionnaire indicated that all of these patients related a better quality of life (62.5%). Through the PAD-test it was possible to observe a decrease in urinary leak of 85% comparing the results pre and post-intervention (BCA—Bacterial Cellulose Application) with p-value equal to 0.000009. Conclusions: The results of this pilot study suggest that the use of biological bulking agent is a promising approach to treat stress urinary incontinence in female patients. Trial registration: Registration number and date of registration should be instated in this section.
References
[1]
Nelson, H.D., Cantor, A., Pappas, M. and Miller, L. (2018) Screening for Urinary Incontinence in Women: A Systematic Review for the Women’s Preventive Services Initiative. Annals of Internal Medicine, 169, 311-319. https://doi.org/10.7326/M18-0225
[2]
Ford, A.A., Rogerson, L., Cody, J.D., et al. (2017) Mid-Urethral Sling Operations for Stress Urinary Incontinence in Women (Review). Cochrane Database of Systematic Reviews, No. 7, CD006375. https://doi.org/10.1002/14651858.CD006375.pub4
[3]
Lightner, J.D., Knoedler, J.J. and Linder, B.J. (2017) Periurethral Bulking Agent Injection in the Treatment of Female Stress Urinary Incontinence. In: Goldman, H.B., Ed., Complications of Female Incontinence and Pelvic Reconstructive Surgery, Springer, Berlin, 297-305. https://doi.org/10.1007/978-3-319-49855-3_27
[4]
Serati, M., Soligo, M., Braga, A., et al. (2019) 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 International, 123, 353-359. https://doi.org/10.1111/bju.14550
[5]
Paterson-Beedle, M., Kennedy, J.F., Melo, F.A.D., et al. (2000) A Cellulosic Exopolysaccharide Produced from Sugarcane Molasses by a Zoogloea sp. Carbohydrate Polymers, 42, 375-383. https://doi.org/10.1016/S0144-8617(99)00179-4
[6]
Pinto, F.C.M., De-Oliveira, A.C.A.X., De-Carvalho, R.R., et al. (2016) Acute Toxicity, Cytotoxicity, Genotoxicity and Antigenotoxic Effects of a Cellulosic Exopolysaccharide Obtained from Sugarcane Molasses. Carbohydrate Polymers, 137, 556-560. https://doi.org/10.1016/j.carbpol.2015.10.071
[7]
Oliveira, M.H., Pinto, F.C.M., et al. (2020) BIO-NAIL: A Bacterial Cellulose Dressing as a New Alternative to Preserve the Nail Bed after Avulsion. Journal of Materials Science: Materials in Medicine, 31, 121. https://doi.org/10.1007/s10856-020-06456-9
[8]
Silva, L.G., Albuquerque, A.V., et al. (2021) Bacterial Cellulose an Effective Material in the Treatment of Chronic Venous Ulcers of the Lower Limbs. Journal of Materials Science: Materials in Medicine, 32, 79. https://doi.org/10.1007/s10856-021-06539-1
[9]
Maia, A.L., Lins, E.M., Aguiar, J.L.A., et al. (2019) Bacterial Cellulose Biopolymer Film and Gel Dressing for the Treatment of Ischemic Wounds after Lower Limb Revascularization. Revista do Colégio Brasileiro de Cirurgiões, 46, e20192260. https://doi.org/10.1590/0100-6991e-20192260
[10]
Silveira, F.C., Pinto, F.C., et al. (2016) Treatment of Tympanic Membrane Perforation Using Bacterial Cellulose: A Randomized Controlled Trial. Brazilian Journal of Otorhinolaryngology, 82, 203-208. https://doi.org/10.1016/j.bjorl.2015.03.015
[11]
Cavalcanti, L.M., Pinto, F.C.M., et al. (2017) Efficacy of Bacterial Cellulose Membrane for the Treatment of Lower Limbs Chronic Varicose Ulcers: A Randomized and Controlled Trial. Revista do Colégio Brasileiro de Cirurgiões, 44, 72-80. https://doi.org/10.1590/0100-69912017001011
[12]
Vilar, F.O., Pinto, F.C., Albuquerque, A.V., et al. (2016) A Wet Dressing for Male Genital Surgery: A Phase II Clinical Trial. International Brazilian Journal of Urology, 42, 1220-1227. https://doi.org/10.1590/s1677-5538.ibju.2016.0109
[13]
Lima, S.V.C., Rangel, A.E.O. andrade, J.L.A., et al. (2014) A New Bulking Agent to Treat Vesicoureteral Reflux: An Experimental Study with Early and Long Term Results. European Urology Supplements, 13, e665. https://doi.org/10.1016/S1569-9056(14)60655-2
[14]
Lima, S.V.C., Rangel, A.E.O., Lira, M.M.M., et al. (2015) The Biocompatibility of a Cellulose Exopolysaccharide Implant in the Rabbit Bladder When Compared with Dextranomer Microspheres plus Hyaluronic Acid. Urology, 85, 1520.e1-6. https://doi.org/10.1016/j.urology.2015.02.028
[15]
Avery, K., Donovan, J., Peters, T.J., Shaw, C., Gotoh, M. and Abrams, P. (2004) ICIQ: A Brief and Robust Measure for Evaluating the Symptoms and Impact of Urinary Incontinence. Neurourology and Urodynamics, 23, 322-330. https://doi.org/10.1002/nau.20041
[16]
Cordeiro-Barbosa, F.A., Aguiar, J.L.A., Lira, M.M.M., et al. (2012) Use of a Gel Biopolymer for the Treatment of Eviscerated Eyes: Experimental Model in Rabbits. The Arquivos Brasileiros de Oftalmologia, 75, 267-272. http://www.scielo.br/pdf/abo/v75n4/10.pdf https://doi.org/10.1590/S0004-27492012000400010
[17]
Fragoso, A.S., Silva, M.B., Melo, C.P., et al. (2014) Dielectric Study of the Adhesion of Mesenchymal Stem Cells from Human Umbilical Cord on a Sugarcane Biopolymer. Journal of Materials Science: Materials in Medicine, 25, 229-237. https://doi.org/10.1007/s10856-013-5056-5
[18]
Howard, D.L., McGlynn, A. and Greer, J.A. (2018) Complications of Sling Surgery for Stress Urinary Incontinence among Female Military Beneficiaries. Journal of Women’s Health, 27, 830-835. https://doi.org/10.1089/jwh.2017.6503
[19]
Vardar, E., Vythilingam, G., Pinnagoda, K., et al. (2019) A Bioactive Injectable Bulking Material, a Potential Therapeutic Approach for Stress Urinary Incontinence. Biomaterials, 206, 41-48. https://doi.org/10.1016/j.biomaterials.2019.03.030
[20]
de Vries, A.M., Wadhwa, H., Huang, J., et al. (2017) Complications of Urethral Bulking Agents for Stress Urinary Incontinence: An Extensive Review Including Case Reports. Female Pelvic Medicine & Reconstructive Surgery, 24, 392-398. https://doi.org/10.1097/SPV.0000000000000495
[21]
Kocjancic, E., Mourad, S. and Acar, O. (2018) Complications of Urethral Bulking Therapy for Female Stress Urinary Incontinence. Neurourology and Urodynamics, 38, S12-S20. https://doi.org/10.1002/nau.23877
[22]
Fontaine, F., Le Mai Tu, F., Carrol, M.S. and Morim, M. (2018) Agreement between Simple Catheter Method and 3D Transperineal Ultrasound for Assessing Urethral Length Measurement before Stress Urinary Incontinence Treatment. Neurourology and Urodynamics, 37, 2875-2880. https://doi.org/10.1002/nau.23805
[23]
Lima, S.V.C., Machado, M.R., Pinto, F.C.M., et al. (2017) A New Material to Prevent Urethral Damage after Implantation of Artificial Devices: An Experimental Study. International Brazilian Journal of Urology, 43, 335-344. https://doi.org/10.1590/s1677-5538.ibju.2016.0271
[24]
Davis, N.F., Kheradmand, F. and Creagh, T. (2013) Injectable Biomaterials for the Treatment of Stress Urinary Incontinence: Their Potential and Pitfalls as Urethral Bulking Agents. International Urogynecology Journal, 24, 913-919. https://doi.org/10.1007/s00192-012-2011-9
[25]
Hussain, S.M. and Bray, R. (2019) Urethral Bulking Agents for Female Stress Urinary Incontinence. Neurourology and Urodynamics, 38, 887-892. https://doi.org/10.1002/nau.23924
[26]
Üre, I., Gürocak, S., Tan, O., et al. (2016) Subureteral Injection with Small-Size Dextranomer/Hyaluronic Acid Copolymer: Is It Really Efficient? BioMed Research International, 2016, Article ID: 2168753. https://doi.org/10.1155/2016/2168753
[27]
Serati, M., Giammò, A., Carone, R., Ammirati, E., Gubbiotti, M., Ruffolo, A., et al. (2021) Bulking Agents for the Treatment of Recurrent Stress Urinary Incontinence: A Suitable Option? Minerva Urology and Nephrology. https://www.minervamedica.it/en/journals/minerva-urology-nephrology/article.php?cod=R19Y9999N00A21050501
