This study aims to create the first validated tool for the objective assessment of urological chronic pelvic pain using the ICS terminology which can be used in conjunction with history taking and examination.

Pain and lifestyle questions were devised with the use of ICS standards, literature review of established pain assessment questionnaires currently in use, expert opinion, and patient focus group for content and face validity.

Women reporting CPP (pelvic pain> 6 months), over 18 years of age, and with a good understanding of the English language were recruited to answer the newly devised questionnaire alongside the McGill’s pain questionnaire, which is a widely used validated pain questionnaire in Gynaecology. 

Pain location was assessed using body maps. Pain triggers such as bladder habits, menstruation, and sexual intercourse were assessed using frequency and severity scales. A pilot study was carried out to confirm feasibility and rationale for study and validation process for self-assessed questionnaire.  The questionnaire was devised with key themes of pain location and characteristics, exacerbating and relieving factors, impact on sexual function, mood, work, and lifestyle. Each symptom asked about had a severity of impact on quality of life (QoL) scale. Overall, a question-based questionnaire was selected.

Sample size power calculation of 310, for power of 0.8, SD 0.34, statistical significance 0.05. Sample size for construct validity of 50. To investigate the logical properties of the questionnaire and validity, participants were asked to complete the questionnaire about their current condition on presentation to the specialist clinic. Following this, they were asked additional questions on the usability of the questionnaire. All data were transformed to numerical form and statistical analysis was performed using SPSS. 
 Pearson's Correaltion was used to asess the test-retest reproducibility for each item. A score of 0 indicates no association, a score less than zero indicates a negative association and a score between 0-1 indicates a positive association. Positive r values indicate the strength of association such as small (0.1-0.3), medium (0.3-0.5) and strong (0.5-1). The presence of symptom and severity for item and subs-score were analysed with intraclass correlation coefficient (ICC). ICC > 0.9 refers to excellent, ICC > 0.75 to good, ICC >0.5 to moderate and ICC < 0.5 to poor correlation. 

Internal consistency was evaluated using Cronbach’s alpha for each subscale separately. A low Cronbach’s alpha indicates a lack of correlation between the items in a scale, thus makes summarising the items unjustified. A high Cronbach’s alpha suggests high correlations among the items on a scale.

Interrater reliability was assessed using Cohen’s Kappa, with <0 indicates no agreement, 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41- 0.60 as moderate, 0.61-0.80 as substantial and 0.81-1.00 as almost perfect agreement.

A total of 360 questionnaires were completed, including 50 which were repeated within 2 weeks for test-retest assessment. The method of completion was 293 and 17 questionnaires completed in paper form and electronically consecutively. 
Mean blank rate was 11.48% 90-46.7%) vs 22.19% 90-49.3%) for McGill's pain questionnaire.

Usability
To assess the usability and patient acceptance of the questionnaires, they were asked additional questions on the relevance, usability, and length of the questionnaire. The relevance was rate as ‘yes’ in 100% of participants with uCPP and 98% of overall CPP group. The overall usability was rated as ‘acceptable’ by 99% of participants (307/310 participants) and ‘somewhat acceptable’ by 0.7% (2/310 participants) and ‘unacceptable’ by 0.3% (1/310 participants). This was explained by  the participant feeling that a electronic version would be more environmentally friendly. The length was felt to be ‘too long' by 43% (133/310) and ‘just right/acceptable' by 57% (177/310).  

Test-Retest Reliability
Pearson’s correlation (test-retest was > 0.5 for all items but one (0.383), which was the description of pain type. For long term reliability, good to excellent values were found for all subitems but three.  The questions on being sexually active and pain characteristic of relation with bladder filling and pain distribution scored  ICC of 0.61,  0.71 and 0.56 respectively.

Internal consistency (Table 1)
Cronbach’s alpha coefficient results were above 0.9 (Excellent) for all 14 relevant question items. McGill’s questionnaire showed the variance of 0.63 (strong).

Criterion Validity
When compared to the McGill’s questionnaire for items on pain location, type and severity, strong correlation was found r^2 =0.63.

Interrater reliability
Cohen’s kappa (inter-rater reliability) of 0.64-0.76.

This is one of the only PROM questionnaire currently available which encompasses the quality of pain, patient symptomology, and it's impact of quality of life including sexual function and relationships. This is something not currently available in other widely used questionnaires. User evaluation of the questionnaire suggests that this tool is relevant and user friendly with a low blank rate. 

The calculation of subscale scores allows for the detection of key symptoms and those that impact significantly on the quality of life where pain may not be consistent across functional domains or may differ in pattern depending on the nature of the pathology.  The use of Likert scales with corresponding visual analogue scores for bother makes this an ideal tool for use as an initial assessment for women with bladder pain and as follow up assessment tool for treatments. This allows measurement of minimal important differences; these are patient derived scores that reflect changes in a clinical intervention that are meaningful to the patient. Many questionnaires currently available lack this 

The high Cohen’s kappa suggests a ‘substantial’ inter-rater and intra-rater reliability for the qualitative items of the questionnaire.  All items of the questionnaire good or excellent internal consistency suggesting that the items are worded appropriately and asked of an appropriate sample. Within the questionnaire, there are some items which are consistently unfilled as not relevant thus may need to be removed from the final version of the questionnaire which may not be apparent from statistical analysis.

The aims of this study were to develop a validated instrument for assessing chronic bladder pain, it’s associated symptoms and impact on lifestyle.  The data indicates that this is a validated and reliable questionnaire with a high content validity and internal consistency. At the time of writing, we believe that this is the only validated questionnaire focusing on urologic chronic pelvic pain.

Doggweiler, R., Whitmore, K. E., Meijlink, J. M., Drake, M. J., Frawley, H., Nordling, J., Hanno, P., Fraser, M. O., Homma, Y., Garrido, G., Gomes, M. J., Elneil, S., van de Merwe, J. P., Lin, A. T.L. and Tomoe, H. (2017), A standard for terminology in chronic pelvic pain syndromes: A report from the chronic pelvic pain working group of the international continence society. Neurourol. Urodynam., 36: 984–1008.doi:10.1002/nau.23072
Chalmers KJ, Catley MJ, Evans SF, Moseley GL. Clinical assessment of the impact of pelvic pain on women. Pain. 2017 Mar 1;158(3):498-504.
Cichowski S, Grzybowska ME, Halder GE, et al. International urogynecology consultation: patient reported outcome measures (PROs) use in the evaluation of patients with pelvic organ prolapse. Int Urogynecol J. 2022;33:2603–31.