Study design, materials and methods
A cross-sectional study was conducted between May 2023 and January 2024, involving 539 women with SUI admitted for sling surgery. Participants completed multiple PRO instruments, including the RAND SF-36 for general health assessment, the PFDI-20 and ICIQ-SF for evaluating pelvic floor distress and urinary symptoms, the HADS for measuring anxiety and depression, and the PISQ-12 for assessing sexual function. The presence of OAB symptoms was determined using the PFDI-20 questionnaire. The reliability and validity of the P-QoL questionnaire in this population were tested. Statistical analysis included Mann-Whitney tests, generalized linear models, and correlation analysis.
Results
Among 539 participants, 440 (81.6%) exhibited OAB symptoms, while 99 (18.4%) did not. Table 1 shows QoL variables by SF-36, PFDI-20 and ICIQ-SF in the total sample and in women with and without OAB. The physical and mental component summary scores of the SF-36 were below 50 in both groups, indicating decreased QoL. Women with OAB had significantly lower physical component scores (p<0.001), but no significant differences were observed in the mental component scores. PFDI-20 and ICIQ-SF scores were significantly higher in the OAB group (p<0.001), confirming greater symptom severity. Abdominal pain was reported in 32% of women, with significantly higher prevalence in the OAB group (42.6% vs. 22%, p<0.001). Anxiety levels were higher in women with OAB (mean HADS-A score: 6.7±3.7 vs. 5.2±3.6, p<0.001), as was depression (mean HADS-D score: 4.8±3.3 vs. 3.5±2.9, p<0.001). No difference in the total score of the PISQ-12 in patients with and without OAB was found: 20.5±0.5 vs 18.3±1.0, p>0.05 (Fig.1). The internal consistency of P-QoL in SUI patients was confirmed by a high Cronbach’s alpha of 0.93 for the entire questionnaire. Significant associations between all domains of P-QoL and ICIQ-SF total score were revealed (p<0.001) – Spearman correlation coefficient varied from 0.177 (personal relationships, 95%CI: 0.054-0.266) to 0.317 (social limitations, 95%CI: 0.235-0.395). Women with OAB had significantly lower QoL across all P-QoL domains compared to those without OAB (Fig.2).
Interpretation of results
The results of this study confirm a significant negative impact of SUI on various dimensions of QoL, especially in women with coexisting OAB symptoms. Patients with OAB demonstrated worse scores in physical health domains, pelvic floor distress, and urinary symptom severity. Additionally, they experienced higher levels of anxiety, depression, and abdominal pain, further contributing to their impaired well-being. Despite no significant differences in sexual function, overall functional limitations were more pronounced in the OAB group. Importantly, the P-QoL questionnaire showed high internal consistency and strong correlation with established instruments (e.g., ICIQ-SF), validating its use in assessing QoL in SUI populations. These findings support the need for a comprehensive, symptom-specific assessment approach in women undergoing evaluation for surgical treatment of SUI, especially those presenting with OAB features, to guide clinical decision-making and improve patient outcomes.