Hypothesis / aims of study
Primary Sjögren’s syndrome (pSS) is a systemic autoimmune disease characterized by exocrine gland dysfunction and various extra-glandular manifestations. While lower urinary tract symptoms (LUTS) are increasingly recognized in pSS, nocturia, as a highly bothersome symptom, has rarely been analyzed as a distinct outcome. This study aimed to estimate the prevalence of nocturia in patients with pSS and identify its clinical and serological determinants.
Study design, materials and methods
We conducted a single-centre retrospective cross-sectional study in a rheumatology outpatient cohort. Participants were identified from a dedicated electronic database of patients with pSS, covering the period from February 2023 to April 2025. All included patients fulfilled the 2016 ACR/EULAR classification criteria for pSS and had documented nocturnal voiding data. Nocturia was defined as waking to void ≥1 time during the main sleep period. Clinical data, including the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI), Patient Reported Index (ESSPRI), sleep quality, and laboratory parameters, were collected and compared between patients with and without nocturia. Multivariable logistic regression was employed to identify independent risk factors for nocturia.
Results
The prevalence of nocturia in the final analytic cohort was 39.2% (280/714). Multivariable analysis revealed that older age (Adjusted OR 1.017, 95% CI 1.001–1.032, P=0.033), poorer sleep quality (Grade 4 vs. 1: OR 2.864, P=0.014), and higher pharyngeal dryness (Grade 4 vs. 1: OR 2.381, P=0.012) were independently associated with a higher risk of nocturia. Conversely, ANA positivity was associated with a lower likelihood of nocturia (OR 0.500, P=0.001). No significant associations were observed between nocturia and systemic disease activity (ESSDAI), renal function, or routine inflammatory markers.
Interpretation of results
These findings suggest that nocturia in pSS is a highly prevalent yet under-recognized symptom and is more closely linked to symptom burden than to classical measures of systemic inflammatory activity or renal impairment. Although age did not differ between nocturia and non-nocturia groups in unadjusted comparisons, its independent association in the multivariable model is consistent with the age-related increase in nocturia risk and may reflect unmeasured comorbidities and medication exposures. The pattern of higher ESSPRI scores driven mainly by dryness and fatigue rather than pain supports a dryness-sleep-fatigue symptom cluster rather than a pain-dominant phenotype. Clinically, this supports routinely asking about nocturnal urinary symptoms in patients with poor sleep or sicca complaints. Associations with poor sleep and pharyngeal dryness also suggest bidirectional relationships among nocturnal awakening, thirst or mucosal dryness, and passing urine. Given that nocturia is linked to sleep fragmentation, impaired daytime functioning and fatigue, a similar interaction in pSS is plausible. The inverse association with ANA positivity raises the possibility that nocturia may cluster within a more symptom-dominant subset of pSS. The lack of independent associations with ESSDAI and routine inflammatory markers indicates that conventional systemic activity measures may not fully capture this aspect of patient burden. However, interpretation should remain cautious because this was a retrospective cross-sectional study, nocturia was not assessed with bladder diaries, and important confounders were not systematically recorded.
Concluding message
Our study reveals that nocturia affects about 40% of Chinese patients with pSS, and is more closely aligned with dryness, fatigue and sleep disturbance than systemic disease activity. Furthermore, the independent association with ANA negativity suggests that nocturia may be a hallmark of a specific symptom-dominant phenotype within pSS.
Clinically, these results underscore the necessity for rheumatologists to proactively screen for nocturia, particularly in patients reporting significant sicca symptoms and sleep disturbances. Managing nocturia through targeted interventions for sleep hygiene and mucosal dryness may serve as a tangible strategy to reduce the overall symptom burden and improve the quality of life for patients with pSS.