A Pelvic Floor Muscle Training–Based Complex Intervention for Community-Dwelling Older Women with Urinary Incontinence: A Feasibility Study (CIA)
Introduction
Urinary incontinence (UI) refers to involuntary urine leakage and is more common among older women. Globally, UI prevalence in older women ranges from about 22% to 80%, with more than a quarter of Chinese women aged 60 and older affected. UI goes beyond physical discomfort; it can trigger anxiety or depression, limit daily activities, and erode self-confidence. The economic burden is substantial, with UI costs estimated at €69.2 billion annually in the European Union (2023) and roughly $82.6 billion in the United States (2020). Clinical guidelines designate pelvic floor muscle training (PFMT) as first-line therapy due to its accessibility, cost-effectiveness, and minimal risk. Yet many patients hesitate to seek help, and more than half of older women with UI do not perform PFMT. Notably, over 80% of Chinese older women with UI report mild to moderate symptoms, which PFMT could effectively manage. Improving PFMT uptake and maximizing its benefits remain key challenges.
Although PFMT’s effectiveness is well established, real-world effectiveness often suffers from poor implementation and adherence. With China’s limited treatment rates and healthcare resources, strategies that focus only on pelvic floor function fall short of fully addressing UI. Therefore, complex interventions that combine multiple interacting components have been proposed to strengthen PFMT implementation fidelity and boost adherence among older women, ultimately enhancing treatment effects. Consequently, we developed a complex intervention for community-dwelling older women with UI, following Medical Research Council guidance. The core PFMT component was integrated with six supporting elements, derived from qualitative interviews to address barriers and facilitators of PFMT adherence in community settings. This evidence-based complex intervention was refined and finalized through multidisciplinary expert consensus.
A feasibility study is a preliminary investigation that informs the design of a subsequent main trial. Before a full-scale trial evaluating effectiveness or implementation, a small-scale feasibility study helps identify methodological uncertainties and assess acceptability, appropriateness, and feasibility of the complex intervention among the target population. Additionally, a process evaluation within a feasibility study assesses whether the intervention was implemented as intended and identifies factors affecting the implementation, aiding refinement for future deployment. This study aimed to evaluate the feasibility of implementing a PFMT-based complex intervention in the community and to identify factors that facilitate or hinder its implementation.
Materials and Methods
This study has two parts. First, a cluster-randomized controlled pilot trial examined the implementation feasibility of the complex intervention, enrolling 36 participants who received either a six-week PFMT-based complex intervention or health education. Primary outcomes focused on acceptability, appropriateness, and feasibility. This portion followed the CONSORT 2010 extension for randomized pilot and feasibility trials. Second, guided by a process evaluation framework, a mixed-methods process evaluation was conducted. Quantitative data came from intervention-period research logs to gauge fidelity, while qualitative data came from post-intervention interviews to identify factors shaping the implementation. The pilot trial is registered in the Chinese Clinical Trial Registry (ChiCTR2300076166).
The Cluster Randomized Controlled Pilot Trial
Participants and Recruitment
Setting
Community daycare centers were chosen as study sites because they provide accessible, familiar environments aligned with older women’s preferences and suitable space for group PFMT sessions. These government-funded, community-oriented facilities are part of China’s elder care system, offering services such as health rehabilitation, social engagement, and health education during daytime hours. In recent years, such centers have become more widespread and well established in China. Eligibility criteria for daycare centers included: (i) a suitable space for group PFMT, and (ii) manager approval.
Participants
Eligible women were: (i) aged 60 years or older and able to walk into the daycare centers independently; (ii) experiencing mild to moderate UI, as measured by the ICIQ-SF (scores 1–14); and (iii) willing to participate. Exclusion criteria included: (i) significant sensory or cognitive impairments that would hinder participation; (ii) current UI treatment; (iii) involvement in other intervention programs.
Recruitment Process
Four daycare centers in Changsha, Hunan, were recruited. After center manager consent, centers were randomly assigned to either the intervention or control arm. Participant recruitment and informed consent occurred after randomization, using on-site presentations and online announcements with center-manager assistance. Community-dwelling older women meeting eligibility criteria were enrolled.
Randomization and Masking
Randomization occurred at the daycare-center level, with all participants at a center assigned to the same arm. A researcher not involved in the trial used a random-number table to assign centers, concealing allocations in sequential opaque envelopes until a center was enrolled. Due to intervention features, participants and implementers were aware of allocations; outcomes were self-reported and assessors were not blinded.
Interventions
The pilot’s primary aim was feasibility rather than effectiveness. Thus, a six-week intervention period was deemed sufficient to assess acceptability, appropriateness, and feasibility. The intervention arm received the six-week PFMT-based complex intervention, which centers on PFMT and includes six supplementary components: symptom and quality-of-life assessment, health education, reminders and supervision, group discussions, a reward system, and a flexible schedule. Trained researchers with a medical background delivered the program. Details are provided in Table 1.
The control arm received six weeks of health education, comprising the health-education component of the complex intervention. Health education is a common approach for community-dwelling older women with UI in China.
Outcomes
Data were collected at baseline, week 3 (midpoint), and week 6 (end). Socio-demographic data (age, marital status, education) were gathered at baseline via a self-developed questionnaire.
Primary outcomes were acceptability, appropriateness, and feasibility of the complex intervention versus health education, measured with the Chinese versions of the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each instrument contains four items rated on a 5-point Likert scale, with a maximum total of 20 points; higher scores indicate better outcomes.
Secondary outcomes included UI symptoms, quality of life, and safety. UI symptoms were assessed with the ICIQ-SF (0–21, higher is worse). Quality of life was measured by the Incontinence Quality of Life (I-QOL) questionnaire (22 items, 0–100, higher is better), covering behavioral restrictions, psychological impact, and social embarrassment. Safety was monitored with a self-developed adverse-events questionnaire detailing specific events, onset, and duration.
Statistical Analysis
A minimum sample size of 12 per arm was deemed appropriate for a pilot based on existing guidance. Categorical socio-demographic data were analyzed with Fisher’s exact test due to small sample sizes; continuous data were checked for normality with Shapiro–Wilk and analyzed with t-tests when appropriate.
Primary and secondary outcomes were analyzed using linear mixed models to account for clustering. Effect sizes were reported as mean differences with 95% confidence intervals. Primary outcomes used a scale-constant covariance structure to address clustering; secondary outcomes used a first-order autoregressive structure. The model included fixed effects for treatment arm and time, with random effects for daycare centers and participants. Safety data were described in detail.
Analyses followed the intention-to-treat principle, comparing outcomes by the center’s randomized group regardless of adherence. Analyses were performed in SPSS 21.0, with p < 0.05 considered significant.
Process Evaluation
Study Design
A mixed-methods process evaluation captured quantitative and qualitative data (see Supplemental Table 2).
Quantitative Data Collection
Implementation metrics during the six-week intervention included recruitment strategies and consent rates, reach (attendance at group sessions), delivery (content and duration), and unintended consequences (adverse events).
Qualitative Data Collection
Interviews with daycare center managers and participants explored contextual factors during implementation, guided by purposive sampling. Interviews occurred after the six-week period, were audio-recorded with consent, and continued until data saturation. Two interview guides were prepared for participants and managers, drawing on the Consolidated Framework for Implementation Research (CFIR) domains: innovation, external context, internal resources, individuals’ needs and opportunities, and implementation process. Home-practice adherence was also explored due to observed low engagement with home training.
Data Analysis
Quantitative data were summarized descriptively. Qualitative data were transcribed within 24 hours and analyzed with content analysis using NVivo 12. A CFIR-based coding manual directed the categorization of statements into facilitators, barriers, or neutral factors. Two researchers independently coded data, resolving disagreements through discussion or a third reviewer. A final list of influencing factors emerged from group discussion.
Results
Pilot Trial Findings
Participant Basics
From October 2023 to January 2024, four daycare centers participated (two in the intervention arm, two in the control). The trial enrolled 36 eligible older women: 22 in the intervention group and 14 in the control group. The participant flow is shown in Figure 1. The baseline characteristics were similar between groups. The average age was 65.0 years (SD 4.98); most reported mild UI symptoms (77.8%), with a mean ICIQ-SF score of 5.75 (SD 3.05).
Acceptability, Appropriateness, and Feasibility
Intervention-related scores on AIM, IAM, and FIM were higher than the control, with mean differences (MD) of 1.25 (AIM) and 1.25 (IAM), and 2.29 (FIM); however, the difference for appropriateness was not statistically significant. Full results are in Table 3 and supplemental materials.
UI Symptoms and Quality of Life
The intervention group showed a lower ICIQ-SF score than the control (MD −1.10, 95% CI −2.73 to 0.52), a difference that was not statistically significant. For quality of life, the intervention group demonstrated a substantial improvement (MD +13.88, 95% CI 6.11 to 21.65), with gains across all I-QOL domains: behavioral limitations (MD +5.07), psychological impact (MD +4.04), and social embarrassment (MD +2.75).
Adverse Events
During the intervention, two adverse events occurred in two participants within separate training groups: lumbar and abdominal soreness in the first week, which improved with rest and progression. No adverse events were reported in the control arm.
Process Evaluation Findings
Recruitment and Reach
Of five invited daycare centers, four joined. Around 75 eligible older women expressed interest, and 36 were enrolled. In the intervention arm, 22 women formed 12 PFMT-focused sessions, with varying attendance: eight women (36%) attended all 12 sessions; 14 (64%) attended at least 10 sessions; 18 (82%) attended eight or more sessions. In the control arm, 14 women were enrolled; four withdrew in week three and two withdrew in week six, with some absences due to scheduling.
Influencing Factors
Interviews with eight participants and two managers identified 23 influencing factors: 18 facilitators, four barriers, and one neutral factor, distributed mainly across the innovation, individual, and implementation-process domains of CFIR. Overall, responses to the complex intervention were positive, but four barriers affected implementation and adherence: low motivation without supervision for home PFMT; monotonous PFMT content reducing engagement; limited promotion and awareness; and the belief that UI is a normal part of aging. Quotes and detailed findings are provided in the supplementary materials and Figure 2.
Home Training Adherence
Interviews revealed that most older women practiced home PFMT irregularly, lacking fixed schedules or clear intensity, contributing to low adherence.
Discussion
This feasibility study examined the practicality of deploying a PFMT-based complex intervention in the community. Feasibility and acceptability were supported by positive primary outcomes and participant/manager feedback. The process evaluation highlighted 23 factors that can inform refinements for future implementation.
Although the results are preliminary due to the small sample size, they indicate meaningful potential and justify a larger confirmatory trial. Notably, the complex intervention achieved higher acceptability than health education, likely due to the group PFMT format that aligns with older women’s preferences, fosters peer support, reduces stigma, and optimizes resource use. The community-based delivery within daycare centers further supports adherence and sustainability. Appropriateness did not differ significantly, possibly due to limited power or because both approaches are relevant for this population.
The control arm’s high withdrawal rate (43%) could affect reliability and may reflect that health education alone struggles to engage older women or retain them for longitudinal data collection. Conversely, it may underscore the need for more engaging interventions. Future studies should consider incentives and clearer communication to minimize dropouts while preserving data quality.
We explored UI symptom and quality-of-life outcomes, though the small sample and short duration limit definitive conclusions. The complex intervention showed a favorable trend in symptoms and a significant improvement in quality of life, particularly in activity limitations, psychological well-being, and social functioning, consistent with PFMT’s known benefits. Two mild discomfort events were reported, suggesting a cautious, progressive approach in future implementations. Qualitative findings point to potential enhancements, such as diversifying exercises (e.g., incorporating yoga or Tai Chi) and adopting stepwise training to ease progression.
Strengths and limitations
Strengths include using reliable, validated measures for implementation outcomes and conducting a process evaluation that incorporated perspectives from both recipients and center managers, informing optimization for future studies. Limitations include selective participation limited to those able to access daycare centers (excluding more stigmatized or mobility-impaired individuals), lack of blinding due to the nature of the intervention, and reliance on self-reported outcomes which may bias results. Additionally, only two managers in the intervention centers participated in the qualitative interviews, which may not capture all perspectives.
Conclusion
Preliminary findings suggest that a PFMT-based complex intervention, designed with participants’ preferences and key implementation determinants in mind, is feasible and acceptable in a community setting, supporting progression to a larger, confirmatory trial. These results help refine future trial designs, improve data collection strategies, consider objective outcome measures, and optimize intervention components based on process-evaluation insights.
Data Sharing
Data from this study are available from the corresponding author on reasonable request.
Ethics and Consent
The Xiangya School of Public Health Ethics Committee approved the study (No. XYGW-2023-65). The study adhered to the Declaration of Helsinki. Written informed consent was obtained from trial participants; verbal consent was provided by interviewees.
Consent for Publication
No identifiable personal data are included; participants and interviewees consented to the use of anonymized data and quotes.
Acknowledgments
The authors acknowledge the assistance of the study team and participants. Note: The manuscript mentions the use of an AI writing tool (ChatGPT-5 mini) to improve language clarity, with authors maintaining responsibility for content quality.
Funding
This work was funded by the National Key R&D Program of China (2020YFC2008600), Hunan Province Science and Technology Innovation Plan (S2022ZCKPZT0047), the Special Funding for the Construction of Innovative Provinces in Hunan (2019SK2141), and the China Oceanwide Holding Group Project Fund (143010100). The funders had no role in study design, data collection, analysis, interpretation, or publication decisions.
Disclosures
The authors declare no conflicts of interest.
Selected References
Key references span guidelines on PFMT effectiveness, prevalence of UI in older women, tools for UI assessment (ICIQ-SF, I-QOL), CFIR-based process evaluation, and prior trials comparing group PFMT to other approaches. These sources support the study’s methodology and interpretation of feasibility and implementation factors.
