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Background: Urolithiasis has a significant impact on patients' health-related quality of life (HRQoL)., Objective: To develop a core patient-reported outcome measure (PROM) using modern psychometric methods to quantify the impact of urolithiasis and different treatments., Design, Setting, and Participants: Adult patients with urinary calculi, attending urology departments, covering all index categories and treatment spectrum, participated during different development phases. The pilot instrument was created from potential items (phases 1 and 2) within the conceptual framework. The instrument was pretested (phase 3) and then underwent psychometric evaluation in two parts (phases 4 and 5)., Outcome Measurements and Statistical Analysis: The validity and reliability of the new PROM were assessed using Rasch measurement theory (RUMM 2030 statistical software) and traditional analyses., Results and Limitations: In total, 683 patients (median age 51 yr, range 18-92 yr) participated during different phases. The initial 60-item draft (five scales) was completed by 212 patients (phase 4). A revised 25-item draft was produced after removal of unstable items. In the second field test, the revised version was evaluated by 369 patients. This led to the final Urinary Stones and Intervention Quality of Life (USIQoL; 15 items) with summated logit scores. The PROM includes three scales: pain with physical health (six items), psychosocial health (seven items) and work performance (two items). Lower scores indicate better outcomes. Results demonstrate that USIQoL is reliable (r ≥ 0.8) and internally consistent (α ≥ 0.7), and has good construct validity (good hypothesised correlations, r > 0.3) and satisfactory sensitivity to change (p < 0.01). All scales demonstrated unidimensionality with good item fit and person separation indices. A limitation is that USIQoL was developed in the English language within the UK population., Conclusions: USIQoL is a short, unidimensional, valid, and reliable PROM for assessing the HRQoL impact of urinary calculi and treatments. It is expected to serve as a core PROM across the entire spectrum of urolithiasis., Patient Summary: Kidney stones are a common condition for which various treatment options are available. The condition and treatments have a significant impact on a patient's quality of life. This can be measured objectively using a valid and reliable patient-reported outcome measure (PROM) developed using modern methods. We have developed a PROM that provides helpful and accurate measurement useful for all stakeholders., (Copyright © 2020 European Association of Urology. All rights reserved.)

Urinary stone disease is a common, often recurrent disease, that can have a negative impact on patients' health-related quality of life (HRQoL), often effecting working, productive members of society. The literature lacks data from structured, qualitative research which could give unique insight into patients' HRQoL. The objective is to understand the impact of urinary stone disease and treatments on patients' HRQoL, from patients' and their relatives' perspective using qualitative and quantitative methodologies. Semi-structured interviews and a focus group were used to understand the HRQoL issues of patients with urinary stones disease, covering the American Urology Association index stone categories. Thematic analysis was performed (using qualitative data analysis software). Familial impact was assessed using the family-related outcome measure (FROM-16©). 62 patients with stone disease and interventions (mean age 51, range 19-92) participated. Data collection stopped when data saturation was achieved. Analysis revealed negative impact of stone disease and interventions on the patients' HRQoL, affecting domains of pain, physical symptoms, outlook on life, work/career, change in lifestyle/diet, social life, difficulties of daily living, travel/holiday problems, relationships and family member impact (106 themes grouped under ten broad headings). Sub-group analyses revealed similar impact in either sex, ureteric and renal stone groups. Recurrent stones were associated with work/financial concerns and treatment preferences varied accordingly. Our qualitative study presents detailed insights into the multidimensional impact of urinary calculi and their treatments on various domains of the HRQoL, confirming previous findings and adding new observations. The findings are expected to help in the development of patient-centric measures and communication tools.

Introduction: Ureteral stents are frequently used in urology practice and have a significant impact on health-related quality of life (QoL). In 2003 . Joshi et al. developed the specific questionnaire for evaluation of QoL and stent-related symptoms, namely Ureteral Stent Symptoms Questionnaire (USSQ). USSQ consists of 40 questions and 2 visual analog scales (VAS), divided into 6 domains. Over the past decade, this questionnaire has been translated into 9 languages. A Russian version of the questionnaire has not been developed yet., Aim: To perform linguistic validation of the Russian version of the USSQ., Material and Methods: Linguistic validation of the original USSQ was performed through a standard process including translation, back translation and pilot study. A total of 103 patients undergone ureteral stent placement and successfully filled in the Russian USSQ at weeks 1 and 4 after stenting, and at week 4 after stent removal. In addition, 30 healthy people filled in the same questionnaires twice at 3-week intervals, as a control group. To evaluate reliability, validity and sensitivity to change of the Russian USSQ, statistical analysis was performed. External criteria included validated questionnaires (EQ-5D, IPSS and pain VAS)., Results: Content validity was approved by experts and proved during patients interviewing. Reliability test-retest was satisfactory for urinary symptoms, body pain, general health, and work performance domains (p<0,001 between test and retest evaluation). USSQ domains showed good correlations between each other (correlation coefficient was 0,80-0,94). Cronbach's alpha coefficient of internal reliability was 0.73-0.95. Correlation between other instruments and corresponding USSQ domains was good (p<0,001), proving criterial validity. Sensitivity to changes after stenting and stent removal was also good for most domains (p less or equal 0,001)., Conclusion: Russian version of USSQ is a valid, reliable and sensitive instrument for the assessment of QoL and stent-related symptoms and is ready for application in the routine clinical practice.

Introduction: Urinary stone disease is a common and often recurrent condition that can affect kidney function and requires a range of medical and surgical treatments, all of which can have a significant impact on patients' health-related quality of life (HRQoL) and treatment preferences., Objective: To review the literature systematically for all studies that include HRQoL measurement or patient preferences in the context of urinary stone disease., Methods: Ovid MEDLINE(R), Ovid MEDLINE(R) In-Process, EMBASE, SCOPUS, EconLit, and Web of Science were searched from inception to January 2016. All study designs with adult participants were included. Narrative synthesis was performed., Results: Thirty-five studies met the inclusion criteria (six randomized controlled trials and 29 observational studies) from 15 countries, including 5472 patients. Eleven studies showed that stone formers had worse HRQoL than the general population; it was noted that stone formers were more likely to suffer from depression. Women have significantly lower HRQoL than men. Twenty-six studies used a generic HRQoL measure and six were nonvalidated disease specific. Studies concerning patient preference were heterogeneous and showed that extracorporeal shock wave lithotripsy is still favored above other interventions and that a large number of patients would prefer the treatment pathway to be decided upon by their clinician., Conclusion: Urinary calculi and its treatment can have significant negative patient impact and influence patient preferences. Patients with stone disease tend to have worse physical and mental HRQoL, quantified using generic measures. Structured research with disease-specific measures underpinned by sound methodology would be beneficial and aid in development of patient-centric management., Systematic Review Registration: This review was prospectively registered with the international prospective register of systematic reviews-PROSPERO 2013:CRD42013006084.

Background and Purpose: Ureteral Stent Symptoms Questionnaire (USSQ) is an intervention-specific health-related quality-of-life (HrQoL) measure. We describe development and validation of the Spanish version., Materials and Methods: We followed established methods to develop the Spanish version of the original USSQ. After pilot testing, we conducted a formal validation study; 70 patients, undergoing placement of ureteral stents, successfully completed the Spanish USSQ as well as the EuroQoL-5D (male and female), the ICIQ male and female lower urinary tract symptoms questionnaires at weeks 1 and 4 after stent insertions, and at week 4 after their removal. In addition, 40 healthy people acted as a control group and completed the same questionnaires twice at 3-week intervals. Statistical analyses were performed to evaluate reliability, validity, and sensitivity to change of the Spanish USSQ., Results: After revision of the initial two drafts after translation, back translation, and pilot testing, a final draft was developed that underwent field testing. Psychometric analyses revealed satisfactory internal consistencies (Cronbach alpha coefficients: 0.73-0. 85) and test-retest reliability (Spearman correlation coefficient: >0.6) for the domains of urinary symptom, body pain, and general health. It demonstrated satisfactory discriminant validity (sensitivity to change, p<0.01), convergent validity (good correlations between the domains of the USSQ and existing validated questionnaires), and test-retest reliability (p<0.001). Analysis of the domains of the sexual matter (21.4%) and work performance (35.7%) were limited because of the small proportion of the study population for whom it was applicable., Conclusions: Results of our development and validation study demonstrate that the new Spanish version of the USSQ is a psychometrically valid intervention-specific measurer for use in the second most common language in the world. It is a reliable outcome measure that could be used for both clinical and research purposes.

Purpose: We validated the Italian version of the Ureteral Stent Symptoms Questionnaire in male and female patients with an indwelling ureteral stent., Materials and Methods: A double-back translation of the original Ureteral Stent Symptoms Questionnaire was performed by 3 urologists and 4 professional translators. A total of 78 patients (cases) with and 35 healthy subjects without (controls) an indwelling ureteral stent were asked to complete the Italian version of the Ureteral Stent Symptoms Questionnaire and a visual analog scale for pain as well as the International Prostate Symptom Score (men) and Urogenital Distress Inventory-6 plus Incontinence Impact Questionnaire-7 (women). Cases were evaluated at weeks 1 and 4 after stent placement, and at week 4 after removal, while controls were evaluated once. The psychometric properties of the questionnaire were analyzed., Results: A total of 66 cases and 30 controls were suitable for analysis. The questionnaire showed good internal consistency in all domains except global quality of life compared with that of the International Prostate Symptom Score (Cronbach's alpha >0.75). Test-retest reliability was good except for the sexual matters domain (Pearson's coefficient >0.7). Relatively high correlation coefficients (greater than 0.65) were found for the visual analog scale for pain, the International Prostate Symptom Score, the Urogenital Distress Inventory-6 and the Incontinence Impact Questionnaire-7 with the corresponding Ureteral Stent Symptoms Questionnaire domains, suggesting good convergent validity. Sensitivity to change and discriminant validity were also good (p <0.001)., Conclusions: The Italian version of the Ureteral Stent Symptoms Questionnaire is a reliable and robust instrument that can be self-administered to male and female Italian patients with an indwelling ureteral stent in the clinical and research settings.

Purpose: Ureteral stents are composed of different polymers and it is unclear if stent composition influences patient comfort. We compared the impact of stents composed of firm and soft polymer on patient health related quality of life., Materials and Methods: A total of 130 patients requiring insertion of ureteral stents during the treatment of urinary calculi were randomized to receive a stent composed of firm (Percuflex, group 1) or soft (Contour, group 2) polymer. Patients were asked to complete the Ureteric Stent Symptoms Questionnaire, a validated instrument, at weeks 1 and 4 with the stent in situ and 4 weeks after its removal, this served as the main outcome measure. Additional assessments included difficulty in stent insertion and the need for early stent removal., Results: There were 78 men and 38 women in total (61 in group 1 and 55 in group 2) with a mean age of 51 years (range 22 to 79) and no difference in age between the 2 groups (p = 0.9). Comparison of the results of the Ureteric Stent Symptoms Questionnaire survey at weeks 1 and 4 with stent in situ revealed no significant differences in the domain scores of urinary symptoms (p = 0.9 and p = 0.8), pain (p = 0.8 and p = 0.6) and general health (p = 0.6 and p = 0.4). Similarly, there were no differences in the number of days with reduced activities, work performance (p = 0.7) and sexual dysfunction between the 2 groups. A similar number of patients (8 and 7 in groups 1 and 2, respectively) required stent removal earlier than planned due to stent related symptoms., Conclusions: This randomized study showed no difference in the impact on patient quality of life between ureteral stents composed of firm or soft polymer.

Purpose: We developed the ureteral stent symptom questionnaire (USSQ), a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents., Materials and Methods: A total of 309 patients were asked to participate during different phases of our study. In phase 1 a structured literature search, 9 patient interviews and studies of 90 patients using existing instruments formed the foundation for the initial draft of our new questionnaire. In phase 2 the USSQ was pilot tested, reviewed by experts and field tested in 40 patients to produce a final 38-item draft. In phase 3 formal validation studies were performed in 55 patients to assess validity, reliability and sensitivity to change. Discriminant validation was performed by administering the questionnaire to 3 groups of patients without stents., Results: The final draft addressed various domains of health (6 sections and 38 items) affected by stents covering urinary symptoms, pain, general health, work performance, sexual matters and additional problems. The validation studies showed the questionnaire to be internally consistent (Cronbach's alpha > 0.7) with good test-retest reliability (Pearson's coefficient > 0.84). The questionnaire demonstrated good construct validity and sensitivity to change shown by significant changes in the score with and after removal of stents. The new USSQ discriminated patients with stents from healthy controls (p < 0.001) and patients with urinary calculi without stents and lower urinary tract symptoms., Conclusions: Indwelling ureteral stents have a significant impact on health related quality of life. The new USSQ is a valid and reliable instrument that is expected to become a standard outcome measure to evaluate the impact and compare different types of stents.

Purpose: We report the prevalence of symptoms associated with ureteral stents, their impact on health related quality of life and utility analysis based on the validation studies of the new ureteral stent symptom questionnaire (USSQ)., Materials and Methods: A total of 85 consecutive adult patients with unilateral indwelling ureteral stents who were asked to participate during the validation phases of the USSQ were considered for this analysis. They were asked to complete the USSQ and the EuroQol, a weighted utility instrument, 4 weeks after stent insertion and removal. In addition, 40 patients were asked to complete these questionnaires 1 week after stent insertion to assess the prevalence of symptoms and utility values at different times., Results: Of the 85 patients 62 (73%) with a mean age of 50 years completed the necessary questionnaires. Urinary symptoms and pain that affected work performance and general health were important stent related problems. Of the patients 78% reported bothersome urinary symptoms that included storage symptoms, incontinence and hematuria. More than 80% of patients experienced stent related pain affecting daily activities, 32% reported sexual dysfunction, and 58% reported reduced work capacity and negative economic impact. The mean EuroQol utility values, which indicate patient satisfaction with treatment, were significantly reduced following stent insertion., Conclusion: Urinary symptoms and pain associated with indwelling ureteral stents interfere with daily activities and result in reduced quality of life in up to 80% of patients. Stents are associated with negative functional capacity and reduced utility values. The results have implications in terms of routine clinical practice, patient counseling and future stent research.

Objectives: To prospectively assess the prevalence and bother of various urinary tract symptoms caused by indwelling ureteral stents using validated questionnaires., Methods: The study consisted of 60 patients with unilateral ureteral stents. Of these, 30 patients were asked to complete the International Prostate Symptoms Score questionnaire, with additional questions on dysuria, hematuria, and loin pain. The remaining 30 patients were asked to complete the International Continence Society questionnaire. These patients were also asked to complete frequency volume charts and undergo uroflowmetry studies. The questionnaires were completed with a stent in situ and 6 weeks after its removal., Results: Forty-eight patients (36 men and 12 women, mean age 52.8 years) completed the study. A large proportion (80%) of patients reported one or more urinary symptoms. Analysis of the IPSS data revealed impaired global quality of life owing to these urinary symptoms. The responses to additional questions on dysuria and hematuria showed a statistically significant difference, but most International Prostate Symptoms Score questions did not. The results of the International Continence Society study identified storage symptoms, incontinence (60%), and bladder pain (80%) as important bothersome problems. The results of the frequency volume charts were in agreement with the storage symptoms., Conclusions: Patients with indwelling ureteral stents have a wide range of urinary symptoms that affect their quality of life. Storage symptoms, bladder pain, and hematuria pose a major bother. None of the existing questionnaires covered the entire range of symptoms. The results are useful in better understanding the urinary symptoms associated with stents and in providing patient counseling.

Introduction: Upper urinary tract obstruction is often relieved by either a percutaneous nephrostomy tube (PCN) or a ureteric stent. Both can cause considerable morbidity and reduce patient's health-related quality of life (QoL). We have compared the QoL in these 2 groups., Patients and Methods: 34 patients (21 stent and 13 PCN) with unilateral ureteric obstruction were prospectively studied. Each patient completed a questionnaire, which included a common single health index (EuroQol EQ-5D) and intervention-specific questions to assess pain, urinary symptoms and day-to-day problems., Results: There were 22 male and 12 female patients [mean age 56+/-9 years (PCN) and 55+/-14 years (stent)]. The mean duration between the intervention and conduct of the survey was 12+/-5 days for PCN and 28+/-14 days for stent. There was no different in the mean EuroQol score (p = 0.199) and analogue score (p = 0.596) indicating no differences in the gross defects in physical and psychosocial function and the utility between the 2 groups. There was a significant difference in the urinary symptoms (p<0.0001) with patients who had a stent experiencing significantly more irritative urinary symptoms. This group also suffered discomfort for a greater duration and in various postures requiring more analgesia (although not significant with Bonferroni correction). Patients with PCN required more help in the daily care of the nephrostomy tube. There was no difference in the incidence of infections and the need for antibiotics., Conclusions: Patients with 'JJ' stents have significantly more irritative urinary symptoms and a high chance of local discomfort than patients with nephrostomy tubes (PCN). However, based on the EuroQol analysis, there is no significant difference in the gross impact on the health-related QoL or the utility between these groups indicating no patient preference for either modality of treatment.

Background: Ureteral stents cause various side effects. We have evaluated health-related quality of life (HRQoL) in patients with stents using validated questionnaires and developed a new stent symptom (intervention)-specific questionnaire (SSQ)., Patients and Methods: Along with structured literature review and in-depth interviews, prospective sub-studies were carried out using generic (SF-36 [N = 30], EuroQol [N = 40], and Functional Status Questionnaire FSQ [N = 20]) and symptom-specific (IPSS [N = 30] and International Continence Society ICS [N = 30]) questionnaires both with a stent in situ and after removal. The results of these studies formed the foundation for a new SSQ that was pilot tested (N = 10) and field tested (N = 20) in order to develop a final draft of the questionnaire that is formally validated., Results: The qualitative research identified a range of problems. Urinary symptoms, pain, work performance, and general health were the most important. Most patients (80%) experienced bothersome urinary symptoms and stent-related pain. Storage symptoms and incontinence were significant urinary symptoms affecting quality of life. As many as 40% of patients experienced sexual dysfunction. The stent had a significant impact on patients' general health. None of the existing measures evaluated the complete impact. The SSQ includes five sections covering urinary symptoms, pain, sexual matters, general health, and work performance. The preliminary results showed it to be valid, reliable (alpha > 0.7) and responsive to the change in scores (p < 0.05) after stent removal., Conclusions: Indwelling ureteral stents are associated with significant morbidity, resulting in a reduced HRQoL in 80% of patients. The SSQ is a reliable intervention-specific instrument that would be useful as an outcome measure to evaluate the impact of stents.