Fractional Co 2 Laser Versus Urogynecological Physiotherapy in Women With Stress Urinary Incontinence: Study Protocol for a Randomized Clinical Trial

Abstract

Background: Stress urinary incontinence (SUI) is recognized as an involuntary loss of urine during physical exertion or a sudden increase in intra-abdominal pressure, such as sneezing and coughing. It is a condition that affects 15% to 30% of women and can negatively impact quality of life, including professional, social, psychological and sexual aspects. Although surgical treatment is considered the gold standard for SUI, it is necessary to offer non-invasive treatments for women with this condition. Pelvic floor muscle training (PFMT) is a physiotherapy modality with proven effectiveness for SUI. The carbon dioxide (CO 2 ) laser is a new tool that has been offered to women with urogenital atrophy, but its effectiveness for SUI is not yet known. We present a study protocol for a prospective non-inferiority randomized clinical trial, comparing the efficacy and safety of CO 2 laser versus physiotherapy for treatment in women with SUI. Methods: Participants recruited for this study (n = 94) will be randomly assigned to two groups. The laser group will receive three vaginal CO 2 laser applications at monthly intervals. The physiotherapy group will undergo 12 weeks of PFMT, twice a week. The impact on SUI, colorectal-anal, pelvic organ prolapse and sexual function will be assessed using validated questionnaires. The response rate to interventions will also be measured. Patients will be assessed at baseline, 3 and 6 months after the intervention. As this is a study protocol, the study is ongoing with an expected end of recruitment and analysis date of 2022. Discussion: The results of this trial will make it possible to evaluate the efficacy and safety of a non-invasive method for the treatment of women with SUI, and offer it as a conservative alternative and a potential option for doctors before making the surgical decision. To date, such evaluation has not been performed, and this intervention we will evaluate is the impact of laser therapy on SUI, quality of life, and sexual dysfunction. J Clin Gynecol Obstet. 2021;10(1):4-10 doi: https://doi.org/10.14740/jcgo713