This single-center RCT was conducted at The First Affiliated Hospital of Wenzhou Medical University to estimate effectiveness of KAP model combined with digital health management on postoperative self-management in BPH patients. This randomized controlled trial was independently developed for the present research objectives and was not embedded within any larger departmental or institutional urology program. The trial was registered in the clinical trial registry under the identifier MR-33-2-0766-47. A total of 120 patients were assessed for eligibility. Out of them, 80 met inclusion criteria and were enrolled. The participants were all male patients (aged ≥60 years) who had undergone surgical treatment for BPH within past month. Additional inclusion criteria were: The patients having basic capability for self-management (cognitive and physical ability to participate in care). The patients were included who have ability to use smartphone or digital device (either personally or with caregiver assistance).

All patients were provided written informed consent to participate. The patients were excluded if patients have severe uncontrolled comorbidities or cognitive impairments. They were excluded if they are having significant post-surgical complications (e.g., recurrent urinary retention, severe infection or re-operation) at baseline. In addition, the patients were excluded if they had inability to complete follow-up (e.g., lack of contact or planning to relocate). The study followed ethical guidelines approved by Clinical Research Ethics Committee of the First Affiliated Hospital of Wenzhou Medical University (Ethical approval number: YS2023, No.286). The trial profile was illustrated using the CONSORT 2025 flow diagram as shown in Figure 1.

Patients were randomly assigned in a 1:1 ratio to Intervention group or Control group using a computer generated random number table. Group allocations were masked in sealed opaque envelopes which were opened after enrollment. Both groups received standard care as per hospital protocols. This included routine discharge education on postoperative expectations, catheter care when applicable, and warning signs; dietary advice to avoid bladder irritants and maintain hydration; guidance on gradually resuming activity; instruction in daily pelvic floor (Kegel) exercises; and medication management for antibiotics, analgesics, and α-blockers. Patients were scheduled for routine follow-up at 1 and 3 months, with additional visits as needed.

On the other hand, the intervention group received additional KAP-based nursing and digital health management measures. Due to nature of intervention, blinding of patients and care providers was not feasible. However, outcome assessors were blinded to group allocation when questionnaires were administered.

Primary outcomes were used to evaluate domains of self-management and recovery. These outcomes included self-efficacy, illness perceptions, health-promoting lifestyle behaviors, and health-related quality of life. The following validated instruments were used to assess postoperative self-management and recovery:

Secondary outcomes included clinical recovery indicators abstracted from medical records and patient self-reports. Firstly, the postoperative complications within 3 months were recorded. Secondly, we recorded the restoration of normal urination by 3 months (defined as ability to void without dysuria, with frequency <8 times/day and minimal urgency, based on patient bladder diaries and physician evaluation). Thirdly, presence of lower urinary tract symptoms (LUTS) like urgency at 3 months was noted. Patients maintained daily urinary diaries for the first month, noting voiding frequency, volumes, and any incontinence episodes or urgent symptoms, and a 3-day diary was repeated at 3 months. These objective logs, along with follow-up exam findings, were used to assess urinary outcomes.

Baseline assessments were conducted postoperatively at enrollment (just prior to intervention initiation). Follow-up assessments occurred at approximately 1 month (end of the intensive intervention period) and at 3 months. The research nurses who collected questionnaire data at follow-ups were not involved to deliver the intervention and were blinded to group allocation. For patients who could not return to hospital for follow-up, assessments were done via secure video call or phone interview and by reviewing their submitted diary records. To promote follow-up completion, reminder calls were made and transportation assistance was offered for in-clinic visits when feasible. All participants completed a 3-month follow-up period, and the overall data collection for the study was completed within a 10-month window, allowing sufficient time for enrollment, follow-up assessments, and verification of submitted records.

Data were analyzed by using SPSS version 29. Continuous variables were presented as mean ± standard deviation (SD). Similarly, categorical variables were presented as frequency (percentage). Baseline comparisons between the control and intervention groups were performed using independent (unpaired) Student’s t-tests for continuous variables and chi-square tests for categorical variables to confirm successful randomization. Because repeated measurements were obtained from the same individuals at baseline, 1 month, and 3 months, group differences over time were evaluated using a two-way repeated-measures ANOVA (Group × Time), which appropriately accounts for within-subject correlations. When Mauchly’s test indicated violation of sphericity, the Greenhouse–Geisser correction was applied. Significant interaction or main effects were followed by post-hoc pairwise comparisons between groups at each time point. To address the risk of alpha inflation due to multiple comparisons, post-hoc pairwise analyses were adjusted using the Benjamini–Hochberg false discovery rate (FDR) procedure. For outcomes assessed repeatedly over time (GSES, HPLP-II, SF-36, and IPQ domains), a two-way repeated-measures ANOVA (Group × Time) was applied, followed by FDR-corrected post-hoc comparisons where appropriate.

Out of 120 patients screened, 80 met the inclusion criteria and were randomized (40 to each group). All of the 80 patients completed the 3-month follow-up with no dropouts. Baseline demographic and clinical characteristics of the two groups are shown in Table 1. The mean age was ~66 years in both groups. The average duration of BPH symptoms before surgery was about 10 years in each, with no significant difference. Baseline International Prostate Symptom Scores (IPSS) were similar. Crucially, there were no significant differences between the control and intervention groups in baseline GSES, total IPQ score, HPLP-II, or SF-36 scores (all p > 0.5). This indicated the successful randomization, as both groups were comparable in initial self-efficacy, illness perceptions, lifestyle behaviors, and quality of life prior to intervention. All post-hoc pairwise comparisons were adjusted using the Benjamini–Hochberg false discovery rate (FDR) correction to account for multiple statistical testing across repeated outcome measurements.

The intervention group demonstrated a significantly greater increase in GSES scores over time compared with the control group. Repeated-measures ANOVA showed a significant Group × Time interaction for GSES scores (p < 0.001), indicating that changes in self-efficacy over time differed significantly between groups. Baseline GSES scores (around 23–24 out of 40) indicated moderate self-efficacy in both groups and did not differ significantly (Table 2, Figure 2). After 1 month, the intervention group’s mean GSES had increased to 28.42 ± 3.42, significantly higher than control group’s 25.12 ± 3.65 (p = 0.001). This improvement in the intervention arm became even more pronounced by 3 months. The intervention group reached a mean GSES of 32.76 ± 4.12 vs. 27.87 ± 5.12 in controls (p = 0.001). Thus, over time the KAP + digital intervention group exhibited a robust gain in self-efficacy, whereas the control group showed only a modest increase. The between-group differences at both follow-ups were highly significant. Importantly, 90% of patients in intervention group achieved a GSES score ≥30 (indicating high confidence) by 3 months, compared to only 55% in the control group.

Participants receiving the KAP-based digital intervention showed markedly larger improvements in overall HPLP-II lifestyle scores than those receiving standard care. Repeated-measures ANOVA demonstrated a significant Group × Time interaction for HPLP-II scores (p < 0.001), with the intervention group showing greater improvements in lifestyle behaviors across follow-up. At baseline, the overall HPLP-II scores indicated moderate engagement in health-promoting behaviors (approx. 129 out of 208 in both groups, with no significant difference). Over time, the intervention group adopted significantly healthier lifestyles than controls (Table 2 and Figure 2). After 1 month, the HPLP-II score of intervention group rose to 138.85 ± 9.43 vs. 130.62 ± 8.46 in controls (p = 0.007). By 3 months, this gap increase with intervention group averaged at 147.76 ± 8.54 as compared to 137.98 ± 8.43 in controls (p = 0.001). Notably, the intervention group improved in all subdomains of the HPLP-II, with largest gains was observed in physical activity and health responsibility. For instance, 80% of intervention patients reported exercising at least 3 times per week by month 3, versus about 50% of controls. Dietary habits also improved; more patients in intervention adopted recommended diets consistently. The control group showed some improvement, but it was markedly smaller.

SF-36 scores increased significantly more in the intervention group than in the control group, indicating broader gains in postoperative well-being. Repeated-measures ANOVA revealed a significant Group × Time interaction for SF-36 scores (p < 0.001), indicating larger QoL improvements in the intervention group compared with controls. Health-related quality of life improved in both groups after surgery. However there was more significant improvement in intervention group. Baseline SF-36 total scores (~64 to 65) reflected the impact of BPH symptoms on well-being of participants prior to intervention. By 1 month, SF-36 score of intervention group increased to 74.26 ± 6.45, compared to 66.18 ± 6.76 in controls (p = 0.001). By 3 months, intervention group achieved mean SF-36 of 78.54 ± 6.76, which surpassed SF-36 of control group, i.e., 70.32 ± 8.43 (p = 0.001), as shown in Table 2 and Figure 2. This indicated a broad enhancement in quality of life domains for intervention patients, approaching levels seen in healthy older adults. In contrast, control patients still lagged behind in overall recovery of well-being. The domains of physical functioning and role limitations (physical) showed particularly large between-group differences. By 3 months, 85% of intervention patients reported no limitation in moderate activities (like walking a few blocks or carrying groceries), versus 60% of controls. Mental health and vitality scores were also higher in intervention group, which showed the improvement in illness perceptions and reduction in anxiety.

We examined illness perceptions of patients by using key IPQ domains (Consequences, Timeline, Control/Cure). Repeated-measures ANOVA demonstrated significant Group × Time interactions across the IPQ Consequences (p < 0.01), Timeline (p < 0.01), and Control/Cure (p < 0.001) domains, indicating that changes in illness perceptions differed substantially between groups over time. Compared with controls, intervention participants showed greater reductions in negative illness perceptions and larger increases in perceived control/cure. At baseline, both groups held comparable insights about BPH. They moderately acknowledged its consequences and chronic nature, and had similar beliefs in controllability (Table 2, Figure 3A, baseline rows; all p > 0.5). After intervention, significant divergences emerged. In consequences domain, this reflects the perceived severity and life impact of condition. At 1 month, the Consequences score of intervention group dropped to 14.82 ± 2.54 from 18.13 at baseline. It indicated that patients viewed impact of BPH as less severe. Meanwhile, the control group remained higher at 17.65 ± 4.32. The difference was significant (p = 0.001). By 3 months, the score of intervention group further improved to 12.74 ± 2.87, versus 16.52 ± 3.56 in controls (p = 0.002). Lower scores in this domain suggest intervention patients felt their condition was better managed and less debilitating over time. In timeline domain, this represents how long-term or chronicity of the patients. At 1 month, intervention patients had lower Timeline score (12.18 ± 2.24) than controls (15.92 ± 3.12; p = 0.001), and similarly at 3 months (11.54 ± 2.43 vs. 14.75 ± 2.65; p = 0.009). Thus, the intervention group moved showed illness as less prolonged or more likely to be resolved, compared to the control group who continued to see it as a longer-term issue. In Control/Cure domain, the degree of optimism was measured about controlling or curing the condition. Higher scores are better here. After 1 month, intervention group reported significantly greater perceived control (16.72 ± 2.98) than controls (13.47 ± 3.65; p = 0.003). By 3 months, this gap increased and showed 18.54 ± 4.74 in the intervention vs. 14.17 ± 2.92 in controls (p = 0.001). Intervention patients grew more confident that their actions and treatment could manage or cure their condition.

In addition to psychosocial measures, we tracked concrete clinical outcomes up to 3 months (Table 3, Figure 3B). The incidence of postoperative complications (primarily mild urinary tract infections and transient urinary retention episodes) was lower in the intervention group (4 patients, 10%) as compared to the control group (10 patients, 25%). Although this difference did not reach conventional statistical significance (χ² = 2.16, p = 0.14) but still it suggested a positive trend. Notably, all complications were minor and managed conservatively. There were no re-hospitalizations for BPH-related issues in intervention group and two in control group (one for urinary retention which requires catheterization, one for severe LUTS which requires medication adjustment).

A significant difference was found in rate of return to normal urination by 3 months. In the intervention group, 37 out of 40 patients (92.5%) had resumed normal voiding patterns, compared to 24/40 (60%) in control group (χ² = 10.65, p = 0.02). Patients in the intervention group reported fewer persistent LUTS. Only 25% reported urgency symptoms at 3 months, versus 45% in controls. Although, this difference was not statistically significant (p = 0.10). The better urinary outcomes in the intervention arm coincide with higher adherence to pelvic floor exercises and earlier reporting of symptoms (due to close monitoring), which allowed timely interventions (like bladder training advice or medication where appropriate).