A prospective randomised controlled trial comparing two ureteric stents (CE marked) using a validated quality of life (HRQoL) questionnaire

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2006
INTERVENTION: Informed written consent will be obtained from 100 prospective patients. Pre stent symptom questionnaire will be completed pre‐procedure. Each patient will be randomised to receive either the Bard Inlay stent of the Microvasice Polaris stent. The type of stent used will be blinded from the patient and the researcher recording information. Once the stent has been indwelling for one week, the stent in situ questionnaire will be completed. Following removal of the stent the post stent questionnaire will be completed. On completion of the questionnaires, comparative scores from the 2 groups will undergo statistical analysis. CONDITION: Urological and Genital Diseases: ; Urological and Genital Diseases PRIMARY OUTCOME: Added 28 July 2008:; Compare health related QOL (using the USSQ) between the two groups at 2 weeks post insertion of stent SECONDARY OUTCOME: Added 28 July 2008:; Difference in GP and hospital visits, UTI and antibiotic use between two groups with stent in situ INCLUSION CRITERIA: Added 28 July 2008: Patients (aged 16 yrs or over) requiring the placement of a ureteric stent for stone disease, including obstructing ureteric stones, large stones prior to lithotripsy or post ureteroscopy plus or minus stone fragmentation.
Epistemonikos ID: a3507106525aaf4ecfb9170e602cf0f1d2e1cc8c
First added on: Aug 21, 2024