Urinary incontinence (UI) is a common issue, especially among older women, with a prevalence ranging from 22% to 80% worldwide. In China, over a quarter of women aged 60 and above suffer from UI, which can lead to physical discomfort, anxiety, depression, and a loss of self-confidence. The economic burden is significant, with annual costs estimated at billions of euros in the EU and billions of dollars in the US. Despite clinical guidelines recommending pelvic floor muscle training (PFMT) as a first-line treatment due to its accessibility, cost-effectiveness, and limited risks, many patients are reluctant to seek help, and over half of older women with UI fail to perform PFMT. This is particularly concerning as most Chinese older women with UI experience mild to moderate symptoms, which could be effectively managed with PFMT. Thus, improving patient uptake and maximizing the benefits of PFMT remain crucial challenges.
The effectiveness of PFMT is well-established, but its practical effectiveness is often hindered by inadequate implementation and poor participant compliance. Given the low treatment rates and limited healthcare resources in China, interventions focused solely on improving pelvic floor function are insufficient for effective UI management. Therefore, complex interventions involving multiple interacting components have been proposed to enhance the implementation fidelity of PFMT and increase adherence among older women, ultimately optimizing the treatment effect.
Building upon the Medical Research Council guidance, a complex intervention for community-dwelling older women with UI has been developed. This intervention has PFMT as its core component, designed based on older women's preferences, and integrates six supporting components systematically derived from qualitative interviews to address barriers and facilitators of PFMT adherence and implementation in community settings. This evidenced-based complex intervention was refined and finalized through multidisciplinary expert consensus.
A feasibility study is a crucial preliminary research step to inform the design and conduct of a subsequent main trial. Before initiating a full-scale trial to evaluate effectiveness or implementation, a small-scale feasibility study is essential to identify methodological uncertainties and assess the acceptability, appropriateness, and feasibility of the complex intervention among the target population. Additionally, the process evaluation within a feasibility study helps evaluate whether the intervention is implemented as intended and identifies factors affecting the implementation process, contributing to the refinement of the complex intervention and informing future implementations. This study aims to assess the feasibility of implementing a PFMT-based complex intervention in the community setting and identify factors facilitating or hindering its implementation.
The study consists of two parts. First, a cluster randomized controlled pilot trial was conducted to evaluate the implementation feasibility of the complex intervention, enrolling 36 participants who received either a six-week PFMT-based complex intervention or health education. The primary outcomes were the acceptability, appropriateness, and feasibility of the complex intervention. This part was reported following the Consolidated Standards of Reporting Trials 2010 statement: extension to randomized pilot and feasibility trials. Second, guided by a process evaluation design and reporting framework, a mixed-methods process evaluation was conducted. Quantitative data were collected via research logs during the intervention period to assess implementation fidelity, while qualitative data were obtained through post-intervention interviews to identify factors influencing the implementation process.
The pilot trial was registered in the Chinese Clinical Trial Registry. Community daycare centers were selected as study sites due to their easily accessible and familiar environments, which align with older women's preferences and provide appropriate space for group-based PFMT sessions. These government-funded and community-oriented facilities offer daytime services such as health rehabilitation, social engagement, and health education for community-dwelling older adults, making them an essential component of China's elderly care system.
Eligible women were required to be aged 60 or above, capable of walking into the daycare centers independently, and experiencing mild to moderate UI, as assessed by the International Consultation on Incontinence Questionnaire-short form (ICIQ-SF), with scores ranging from 1 to 14. Women were excluded if they exhibited severe functional deficits in vision, hearing, and comprehension that would hinder participation, were currently receiving treatment for UI, or were involved in any other intervention programs.
Four community daycare centers that met the eligibility criteria were recruited in Changsha, Hunan, China. After obtaining consent from the center managers, the daycare centers were randomly assigned to either the intervention or control arm. Participant recruitment and informed consent were conducted after community daycare centers randomization, using a combination of on-site presentations and online announcements, with assistance from the daycare center managers.
The primary objective of a pilot study is to assess feasibility rather than effectiveness. Accordingly, a 6-week intervention period was considered sufficient to assess the intervention's acceptability, appropriateness, and feasibility. Participants in the intervention arm received a 6-week complex intervention developed previously, with PFMT as the core component and six supplementary components: symptom and quality of life assessment, health education, reminder and supervision, group discussion, reward system, and flexible schedule. The intervention was delivered by trained researchers with a medical background.
The control arm received a 6-week health education, consisting of the "health education" component from the complex intervention. Health education is a commonly used strategy for community-dwelling older women with UI in China. Data were collected at baseline, week 3 (mid-point), and week 6 (end-point). Socio-demographic characteristics such as age, marital status, and education level were collected at baseline using a self-developed questionnaire.
The primary outcomes were acceptability, appropriateness, and feasibility of the two interventions (the complex intervention or the health education), measured using the Chinese versions of the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each questionnaire consists of four items rated on a 5-point scale, with higher scores indicating better acceptability, appropriateness, and feasibility of the intervention.
The secondary outcomes included improvement in UI symptoms, quality of life, and safety. UI symptoms were assessed using the ICIQ-SF, a brief patient-reported questionnaire, with higher scores indicating more severe symptoms. Quality of life was assessed using the self-reported Incontinence Quality of Life Questionnaire (I-QOL), which consists of 22 items organized into three domains: behavioral restrictions, psychological impact, and social embarrassment. Safety information was assessed using a self-developed adverse events questionnaire.
A sample size of no less than 12 older women with UI per arm was estimated based on the literature recommendation for sample size in pilot studies. For the socio-demographic characteristics, categorical data were analyzed using Fisher's Exact test due to the sample size of less than 40. Normality of all continuous variables was assessed using the Shapiro–Wilk test. All continuous data were normally distributed, and Student's t-test was used for analysis.
The analysis of primary outcomes utilized a linear mixed model, with effect size quantified using the Mean Difference (MD) along with its 95% confidence interval (CI). For primary outcomes, a scale-constant covariance structure was assumed to account for the clustering effect. For secondary outcomes, a first-order autoregressive covariance structure was assumed to account for the clustering effect, acknowledging the inherent correlation between the repeated measures data. The model included fixed effects for treatment arm and time to repeated-measure, while random effects accounted for variations among different community daycare centers and participants. Safety-related information was described in detail.
The data analyses were carried out on the principle of intention to treat, comparing outcomes between participants according to their community daycare centers randomization assignment, regardless of their actual adherence to the intervention. All the analyses were conducted using SPSS 21.0, with P < 0.05 considered statistically significant.
A mixed-methods approach was used to collect both quantitative and qualitative data for the process evaluation. The main aspects assessed are outlined in the supplemental materials. Quantitative data on the implementation of the complex intervention were collected during the 6-week intervention period, with research logs serving as the primary tool to document recruitment, reach, delivery, and unintended consequences.
Qualitative interviews were conducted to obtain feedback from daycare center managers and older women and explore the contextual elements during the implementation of the complex intervention. These components are collectively referred to as the influencing factors in the implementation process. Purposive sampling was adopted to select the participants and managers from the community daycare centers in the intervention arm. After the 6-week intervention period, interviewees were invited to participate in face-to-face interviews, which were audio-recorded with oral consent. The sample size was determined according to the principle of data saturation.
Two versions of the interview guide were developed to capture perspectives from both participants and daycare center managers. The interview content covered five areas of the Consolidated Framework for Implementation Research (CFIR) framework: Innovation, External factors, Internal factors, Individuals, and Implementation process. Due to the poor adherence to home practice of the complex intervention, questions about home practice were added to the interview guides for participants to explore the compliance of participants at home practice and related reasons.
In the process evaluation, both quantitative and qualitative data were collected and analyzed. The quantitative data contained only categorical variables, which were summarized using frequencies and percentages for descriptive analysis. Qualitative data were analyzed using content analysis with the assistance of NVivo 12.0 software. First, a coding manual was formed based on the CFIR framework. Second, the meaningful statements in the transcriptions were coded and classified according to the coding manual. Finally, the categories were assessed as facilitators, barriers, or neutral factors.
From October 2023 to January 2024, four community daycare centers were enrolled in the pilot trial. Two daycare centers were randomized into the intervention arm, while the remaining two were assigned to the control arm. A total of 36 eligible older women participated in the intervention program, with 22 in the intervention arm and 14 in the control arm. The flow of participants through the study is shown in Figure 1.
As shown in Table 2, baseline characteristics of the participants were similar between arms. Overall, participants had a mean age of 65.00 years. Most of the participants had mild UI symptoms, with a mean ICIQ-SF score of 5.75.
The intervention arm exhibited higher AIM, IAM, and FIM scores compared to the control arm, with Mean Differences (MDs) and their corresponding 95% CIs being 1.25 (0.19, 2.31), 1.25 (−0.02, 2.53), and 2.29 (0.78, 3.81), respectively. However, no significant difference was observed in the appropriateness score. The results of the main effect are shown in Table 3.
Regarding UI symptoms, the intervention arm exhibited a lower ICIQ-SF score compared to the control arm, with a MD and a 95% CI of −1.10 (−2.73, 0.52), but no significant difference was observed. Regarding quality of life, the intervention arm exhibited a higher I-QOL score compared to the control arm, with a MD and a 95% CI of 13.88 (6.11, 21.65). The results for all three domains of the I-QOL showed that the complex intervention led to higher scores in behavioral limitation, psychological influence, and social embarrassment.
During the intervention period, the intervention arm reported two adverse events, each occurring in a separate training group. Specifically, two older women experienced lumbar and abdominal soreness during the first week of group-based training. These symptoms were relieved by rest and subsequently resolved as the training progressed. No adverse events were reported in the control arm.
Five community daycare centers were initially invited to participate, with four consenting and subsequently enrolled. One daycare center manager declined participation due to concerns about the training room's location on a relatively high floor, which might hinder accessibility for older women.
Following the randomization of the included daycare centers, recruitment of older women was initiated at each center. In total, 75 older women across all four daycare centers expressed a willingness to participate, and 36 of them met the eligibility criteria and were enrolled.
At the community daycare center level, each daycare center formed a distinct intervention group based on the number of participants enrolled. All intervention content was delivered by an implementation team consistently at each daycare center. In the intervention arm with 22 older women, the complex intervention comprised 12 sessions of group-based PFMT. Specifically, eight older women (36%) had a 100% attendance rate, 14 (64%) had an attendance rate of over 80%, and 18 (82%) had an attendance rate of over 67%.
In the control arm with 14 older women, four withdrew during the third week of data collection, and two withdrew in the sixth week, with no reasons provided. Additionally, three older women were absent from data collection in the third week due to scheduling conflicts but participated in the sixth week.
Eight older women and all two daycare center managers in the intervention arm were interviewed after the intervention period. A total of 23 influencing factors were identified, including 18 facilitators, four barriers, and one neutral factor. These factors cover five domains and 14 constructs of the CFIR, mainly distributed in the innovation, individual, and implementation process domains. Both daycare center managers and older women expressed positive responses to the complex intervention. However, four barriers affecting the implementation and adherence of the complex intervention were identified.
First, low motivation was identified due to the lack of supervision, which reduced the willingness to engage in home-based PFMT, often deprioritized relative to daily activities. Second, monotonous content of PFMT led to decreased interest and negatively affected adherence. Third, limited promotion hindered participation due to insufficient awareness of the intervention. Fourth, many older women perceived UI as a normal part of aging, and this misconception further impeded engagement.
The reasons for the low attendance rate of home training during the intervention period were that the majority of older women persisted unstructured home training at their discretion, lacking a fixed training schedule, consistent frequency, and clearly defined intensity.
The preliminary results of this pilot trial indicate that the PFMT-based complex intervention is feasible and acceptable in a community setting, as reflected by positive findings in the primary outcomes and feedback from interviews. The process evaluation identified 23 factors influencing the implementation of the complex intervention, providing valuable insights for refinement and future implementation.
Although the implementation outcomes are preliminary due to the small sample size, they suggest meaningful potential and support further evaluation in a larger confirmatory trial. The complex intervention exhibited significantly higher acceptability than health education, which may be attributed to the group-based PFMT component that aligns with older women's preferences. This format not only enhanced peer support and reduced stigma but also conserved human and financial resources. Additionally, components targeting factors affecting implementation likely contributed to the higher feasibility observed.
Delivering the complex intervention in community daycare centers, which align with both the elderly-centered institutional values and older women's preferences, further enhanced adherence and may promote long-term sustainability. However, differences in appropriateness were not statistically significant, which may be due to the limited sample size or may indicate that both interventions are practically relevant for addressing older women with UI.
Notably, the high withdrawal rate in the control arm (43%) may reduce the reliability of our findings. This could be due to selective retention of participants more positively inclined toward health education, leading to a lack of statistical significance and an underestimation of implementation outcomes. On the other hand, the high withdrawal rate may also support our results, as it probably reflects health education failing to engage older women effectively and reducing their commitment to longitudinal data collection.
Future studies should incorporate strategies such as incentive measures and clearer communication to minimize withdrawal while maintaining comparability and data quality during study design. The study also conducted a preliminary exploration of the effects of the complex intervention on UI symptoms and quality of life, as the primary focus was on assessing feasibility and acceptability. Although the intervention showed a positive trend in symptom improvement, the lack of statistical significance may be due to the short intervention duration and limited sample size.
Moreover, the complex intervention significantly improved participants' activity limitations, psychological impact, and social restrictions, contributing to enhanced quality of life, which aligns with previous evidence. Despite these results being preliminary, they suggest potential effects, supported by the observed positive trends and the well-established benefits of PFMT. Additionally, two cases of mild discomfort during the PFMT were reported, consistent with previous reports. These findings provide guidance for refining the intervention, indicating that stepwise training techniques should be adopted in future implementations.
The process evaluation indicated that the complex intervention could be implemented in the community as planned, while also identifying barriers for future optimization. Notably, 36% of older women in the intervention arm attended fewer than 80% of the group training sessions, possibly due to scheduling conflicts with competing priorities. To mitigate this anticipated challenge, home-based training was included as a supplementary component. However, unstructured home training was reported in practice, which may compromise the PFMT effectiveness.
Qualitative interviews revealed facilitators to implementation, including innovation (e.g., group-based PFMT, low cost), internal factors (e.g., availability of space), and individual factors (e.g., capability and opportunity), which ensured successful delivery and enhanced participants' adherence. Conversely, given the observed barriers, future studies could explore task-shifting approaches, such as training peer leaders among older women or community daycare center managers to organize supervised group training sessions. The monotonous training content could be addressed by integrating diverse forms of exercise, such as yoga or tai chi.
One of the main strengths of this study was the use of reliable and validated tools to assess the implementation outcomes of the complex intervention, which is essential for evaluating the success of implementation efforts. Additionally, a process evaluation was conducted to understand the influencing factors of the implementation. The involvement of both recipients of the complex intervention and managers of the implementation setting provided multiple perspectives about the complex intervention, hence, it provides the basis for the complex intervention optimization and promotion in future studies.
Several limitations of this study should be acknowledged. First, participation was restricted to older women who were able to access community daycare centers, thereby excluding those who faced stigma or had mobility issues. Even so, the findings hold important implications for older women experiencing mild to moderate UI symptoms. Second, blinding was not implemented due to the nature of the intervention, and the use of patient-reported outcomes may have led to underestimation of the outcomes, particularly among participants assigned to the less engaging control arm. Future studies could consider using objective outcome measures, such as pad tests or urodynamic assessments.
Third, while we included the two managers from both community daycare centers of the intervention arm in the qualitative interview for the process evaluation, this limited number of interviewees may not capture the perspectives of all daycare center managers. The preliminary findings indicate that the PFMT-based complex intervention, developed with consideration of participants' preferences and implementation influence factors,
