Hypothesis / aims of study
Chronic pelvic pain (CPP) in women often presents with overlapping symptoms from the lower urinary tract, genital organs, and neuromuscular structures, leading to diagnostic delays (the “diagnostic odyssey”). Existing Patient-Reported Outcome Measures (PROMs) primarily assess symptom severity rather than identifying the anatomical source of pain. We hypothesized that a domain-specific questionnaire could accurately differentiate between urological, gynecological, and neuromuscular causes of CPP at the initial consultation.
Study design, materials and methods
A systematic, stepwise approach was used to develop the questionnaire:
Item generation: Literature review of 7 validated instruments (GUPI, PUF, O’Leary/Sant, VSQ, etc.) and patient interviews (n=45) generated an initial item pool.
Content validation: Expert panel (urologist, gynecologist, neurologist) assessed relevance using Content Validity Index (CVI). Cognitive interviewing (n=45) refined item clarity.
Psychometric validation: The final 11-item version was tested in 195 women: 50 with chronic recurrent cystitis, 50 with gynecological pathology, 25 with interstitial cystitis/bladder pain syndrome (IC/BPS), 25 with neuromuscular pelvic pain, and 45 healthy controls. Internal consistency was assessed using Cronbach’s α. Diagnostic accuracy was determined using ROC analysis, with clinical diagnosis as the gold standard. Sample size calculations ensured adequate power for subgroup analyses.
Results
The final questionnaire comprised 11 questions grouped into three domains: Lower Urinary Tract (LUT, 5 items), Female Genital Organs (FGO, 3 items), and Neuromuscular Structures (NMS, 2 items), plus one Quality of Life visual analog scale. The total score range is 0–30.
Internal consistency: Cronbach’s α was 0.85 for the total score; 0.80 (LUT), 0.75 (FGO), and 0.70 (NMS) for the domains.
Diagnostic accuracy: The area under the ROC curve (AUC) for distinguishing patients (n=150) from healthy controls (n=45) was 0.94 (95% CI 0.91–0.97). Domain-specific cut-off values demonstrated high diagnostic efficacy:
Diagnosis Defining Domain Cut-off Sensitivity (%) Specificity (%)
Gynecological pathology FGO ≥6 88.2 84.6
Chronic recurrent cystitis LUT ≥7 85.7 83.1
Neuromuscular CPP NMS ≥2 79.3 81.8
Interstitial cystitis/bladder pain syndrome (IC/BPS) LUT + NMS (total) ≥10 83.9 89.5
Mean completion time was 4.8 ± 1.3 minutes.
Interpretation of results
The three-domain structure effectively differentiates between conditions that often present with similar symptoms. The high AUC (0.94) confirms excellent discriminative ability. The combination of high LUT and NMS scores (total ≥10) is indicative of IC/BPS, aligning with the ICS framework that recognizes the involvement of both urological and neuromuscular domains in chronic pelvic pain syndromes. The tool also captures comorbidity (e.g., high FGO and LUT scores suggesting combined gynecological pathology and chronic recurrent cystitis), which is common in clinical practice but often missed by single-disease instruments.
Concluding message
The “Questionnaire for the Diagnosis of Pelvic Organ Conditions and Syndromes in Women” is the first Russian-language tool validated specifically for differential diagnosis rather than just symptom severity assessment. With high reliability (α=0.85), strong diagnostic accuracy (AUC 0.94), and a short completion time, it is a practical, valid instrument for urologists, gynecologists, and neurologists to identify the primary source of pelvic pain, potentially shortening the diagnostic pathway and facilitating personalized treatment.