Mirabegron in the management of lower urinary tract symptoms (LUTS) related to double-J (JJ) ureteral stents.

INTERVENTION: Trade Name: Betmiga Product Name: mirabegron Product Code: YM178 Pharmaceutical Form: Prolonged‐release tablet INN or Proposed INN: mirabegron CAS Number: 223673‐61‐8 Current Sponsor code: YM178 Other descriptive name: MIRABEGRON Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Prolonged‐release tablet Route of administration of the placebo: Oral use CONDITION: Insertion of a JJ stent, prior to extracorporal shock wave lithotripsy (ESWL) and post ureterolithotripsy. ; MedDRA version: 19.0 Level: LLT Classification code 10046707 Term: Urolithiasis System Organ Class: 100000004857 Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Surgical Procedures, Operative [E04] PRIMARY OUTCOME: Main Objective: The study’s primary objective is to evaluate the efficacy of Mirabegron in decreasing JJ‐ related LUTS for urolithiasis when compared to placebo. Primary end point(s): Difference between the two arms in the average urinary symptoms score of visits 2 and 3 as reported in the Ureteral Stent Symptom Questionnaire (USSQ). Secondary Objective: The study’s secondary objective is to evaluate if there is an improvement in health related quality of life (HRQoL) of treatment with Mirabegron versus placebo. Timepoint(s) of evaluation of this end point: end of subjects' follow up SECONDARY OUTCOME: Secondary end point(s): 1. Difference between the two arms in the urinary symptoms score of visit 2 as reported in the USSQ.; 2. Difference between the two arms in the urinary symptoms score of visit 3 as reported in the USSQ.; 3. Difference between the two arms in the average score of visits 2 and 3 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index).; 4. Difference between the two arms in the score of visit 2 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index).; 5. Difference between the two arms in the score of visit 3 in the remaining USSQ domains (pain symptom index, general health index, work performance index, sexual matters index).; 6. Difference between the two arms in the average daily VAS measurements. ; 7. Difference between the two arms in the average VAS measurements of the period between visit2 and visit 3.; 8. Difference between the two arms in the number of days for duration of JJ stent in situ. Timepoint(s) of evaluation of this end point: end of subjects' follow up INCLUSION CRITERIA: • Subject is male or female and at least 18 years of age; • IEC/IRB ‐approved written Informed Consent (IC) and privacy language as per national regulations has been obtained from the subject or legally authorized representative prior to any study‐related procedures (including discontinuation of prohibited medication, if applicable); • Female subject who is of childbearing potential* must have a negative urine pregnancy test at screening and must be using highly effective contraception. • Female subject must not be breastfeeding at Screening or during the study period and for 28 days after final IMP administration; • Female subject must not donate ova starting at Screening and throughout the study period and for 28 days after final IMP administration; • Male subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception starting at Screening and continue throughout the study period and for