Comparison of the efficacy of Uretero-renoscopic Lithotripsy with Extracorporeal Shock Wave Lithotripsy (ESWL) on clinical and patient-reported outcomes among patients with proximal ureteric stones- A Randomized Controlled Study.

Patients with ureteric calculus measuring size less than 1.5 cm after standard clinical assessment and investigations will be assesed for eligibility to participate in the study. Those who are eligible based on the inclusion and exclusion criteria will be included in the study recruited into the study after informed consent,.

The patient will be randomized into the uretero-renoscopic lithotripsy or ESWL group as per allocation by the technique described above.

Age, sex, demographic and clinical details will be noted down.

Patients will undergo URSL or RIRS by standard method by experienced urologists. Patient will undergo primary ureterorenoscopy and lithotripsy with 7 Fr ureterorenoscope and pneumatic/laser lithotripsy. Patients will be reassessed after discharge at the end of 2 weeks for development of any complications. The stone clearance will be assessed when the patient comes for follow up at 2 weeks with the help of X-ray KUB/ NCCT KUB (radiolucent stones). The patient reported outcome measures (Annexures no. 1 and 2) will be measured at 2 weeks.

Patients in the ESWL group will undergo ESWL by Dornier compact alpha lithotripter III (Dornier MedTech System GmbH) under sedoanalgesia in the presence of urology senior resident and experienced urology technician. Patients will be assessed after 2 weeks with the help of X-RAY (radio-opaque stones) or NCCT (radiolucent stones). If stones are not cleared, they will be asked to undergo 2 more sessions. A maximum of only 3 sessions (4 weekly intervals) will be given to the patient. If stones are not cleared at the end of 3 sessions, it will be considered as an ESWL failure. Such patients will be advised to undergo RIRS or PCNL depending on the clinical assessment by the consultant. The PROMs will be measured 2 weeks after the end of the stone clearance session. The complications will also be noted down.

Complete stone clearance will be considered when the residual calculus at the end of either interventions will be less than 3 mm

PROMs will be assessed with the help of EQ-5D-5L health questionnaire provided to the patients at the end of treatment in the language that they understand. The interview will be conducted after briefing them the purpose of the interview. Informed written consent will be obtained from each respondent before the interview. Confidentiality will be maintained for the data obtained as per ethical guidelines (Indian Council of Medical Research, 2000). Each patient will be asked to state the level of severity in each of the five domains based on the predefined condition. The severity level of each domain will be transformed into score by giving values for no problem as 0 and for mild, moderate, severe and extreme severe problem as 1, 2, 3 and 4, respectively. The values will be computerized for further analysis.