Short title: CONQUER-score

Aim: To develop and validate a symptom-based scoring system for urinary dysfunction after treatment for non-muscle invasive bladder cancer (NMIBC)

Number of patients: We expect to include 1000 patients from the cross-sectional study.

Method: For this study we will develop and validate a scoring system for urinary, sexual and bowel dysfunction after treatment. The primary draft of the questionnaire for the score will be based on a thorough review of the literature and assessment by an expert panel. Questionnaires regarding symptoms and QoL will be sent to all eligible patient identified in the The National Patient Registry (LPR). Patients are eligible if they are above the age of 18 years, have a primary bladder cancer pTa or pT1a and are treated with TUR-B.

Associations between items and QoL will be computed by binomial regression analyses. The important/significant items will be selected and regression analysis will be performed in order to find the adjusted risk ratios. Individual score values will be designated items to form the symptom-score, dividing the outcome into “no impact,” “minor impact,” and “major impact on QoL”. Validity will be tested by receiver operating characteristic (ROC) curve and Spearman’s rank correlation and discriminant validity will be tested by Student t tests.

Sites: This study is a national study, inviting patients treated at all sites in Denmark.