Patients with Neurogenic Lower Urinary Tract Dysfunction (NLUTD) often associate with other problems, such as bowel dysfunction, sexual dysfunction, and psychological disorders. Until now, there is no instrument for comprehensive evaluation of these symptoms in patients with NLUTD. This study aims to design and evaluate a comprehensive patient-reported outcome measure for patients with NLUTD.

Based on literature review and opinions of the patients, professionals and experts, a draft questionnaire was generated. This newly designed questionnaire included seven domains including urine storage symptoms, urination symptoms, post micturition symptoms, intestinal symptoms, anxiety symptoms, pain symptoms and sexual symptoms. Patients with NLUTD were recruited to complete the questionnaire. The critical ratio method was used to assess the program quality. Cronbach’s alpha and test-retest reliability were used to test the reliability of the scale. Exploratory factor analysis, the content validity index, the content validity ratio, kappa statistics and concurrent validity were used to test the validity of the questionnaire.

A comprehensive neurogenic lower urinary tract dysfunction scale (CNLUTDS) was designed and evaluated. Ninety patients completed the questionnaire twice. It demonstrated good internal consistency (Cronbach’s alpha =0.762), test–retest stability (0.825–0.992), and validity (Kaiser-Meyer-Olkin=0.727, content validity index≥0.89, content validity ratio≥0.78, and kappa statistics≥0.89). The correlation between the dimensions of the scale and the total scale was 0.306-0.720 (p<0.05); the correlation between the SF-36 and the total scale was -0.354 (p<0.05). The questionnaire results were presented as a radar chart to allow better visualization of the changes in the patients’ symptoms.

The clinical assessment of NLUTD relies heavily on patient-reported outcome measure (PROM). The current questionnaires are limited by their lack of comprehensive evaluation of symptoms in patients with NLUTD. Comprehensive evaluation of patients’ status by accomplishing all of the present measurements is a very time-consuming process and is not available for the routine diagnosis and follow-up of patients with NLUTD. Hence, a comprehensive, concise and intuitive PROM for patients with NLUTD is urgently needed. Our study developed a PROM to comprehensively assess systemic symptoms related to NLUTD. This new instrument provides an intuitive, valid, and reliable method for the diagnosis and follow-up assessment of patients with NLUTD, based on their systemic symptoms. The CNLUTDS demonstrated good reliability, validity, and test–retest reliability in the target population.

CNLUTDS is a novel patient-reported outcome measure to assess the whole changes of patient's symptoms with strong reliability and validity. This instrument can facilitate the treatment and follow-up of patients with NLUTD.