A Pelvic Floor Muscle Training-Based Complex Intervention for Community-Dwelling Older Women with Urinary Incontinence: A Feasibility Study and Process Evaluation.

Purpose: Urinary incontinence is a common health issue among older women, negatively affecting quality of life. Although pelvic floor muscle training (PFMT) is recommended as the first-line treatment, its uptake remains low. We previously developed a PFMT-based complex intervention to improved adherence and implementation fidelity among community-dwelling older women. This study aimed to test its acceptability and feasibility. Patients and Methods: This study consisted of two parts. First, a cluster randomized controlled pilot trial was conducted in Changsha, China. Four community daycare centers were randomly assigned to the intervention arm (receiving the PFMT-based complex intervention) or the control arm (receiving health education). Primary outcomes were the acceptability, appropriateness and feasibility of the complex intervention. Additionally, a mixed-method process evaluation was conducted to assess the implementation fidelity and the contextual factors influencing the implementation outcomes, with quantitative data collected from research logs and qualitative data from interviews, respectively. Results: From October 2023 to January 2024, the pilot trial enrolled 36 eligible older women, with 22 in the intervention arm and 14 in the control arm. Compared with health education, the complex intervention demonstrated greater acceptability, appropriateness, and feasibility, with mean differences and corresponding 95% confidence intervals being 1.25 (0.19, 2.31), 1.25 (-0.02, 2.53) and 2.29 (0.78, 3.81), respectively. The process evaluation revealed that the complex intervention was implemented successfully, with 48% of the approached older women enrolled and intervention content delivered as planned. However, low motivation, monotonous content, limited promotion and inadequate attention were identified as barriers requiring further improvement. Conclusion: Our preliminary findings indicate that the PFMT-based complex intervention, developed with consideration of participants' preferences and implementation influence factors, is acceptable and feasible. These findings support a larger confirmatory trial and indicate that future research should further improve data collection strategies, adopt objective outcome measures, and optimize intervention components.