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

Phase 1

• Conditions: Insertion of a JJ stent, prior to extracorporal shock wave lithotripsy (ESWL) and post ureterolithotripsy.; MedDRA version: 19.0Level: LLTClassification code 10046707Term: UrolithiasisSystem Organ Class: 100000004857; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2015-004013-25-GR
• Lead Sponsor: Institute of Molecular Medicine and Biomedical Research- I.M.B.E.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-25
• Last Update Posted: 4 September 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 90 days after final IMP administration;
•Male subject must not donate sperm starting at Screening and throughout the study period and for at least 90 days after final IMP administration;
•Insertion of the same JJ Stent (Percuflex, Boston Scientific, 4.8 Fr, 26 cm)
•No history of JJ stent insertion
•Estimated duration of stenting: 2 weeks
* A female subject is either:
•Of non-childbearing potential:
-Post-menopausal (defined as at least 1 year without any menses) prior to registration or
-Documented surgically sterile (at least 1 month prior to registration or status post
hysterectomy)
•Or, if of childbearing potential,
-Must have a negative urine pregnancy test prior study registration
-Must use effective form of birth control throughout the study.

Acceptable forms of birth control include:
- established use of oral, injected or implanted hormonal methods of contraception
- placement of an intrauterine device (IUD) or intrauterine system (IUS)
- barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/suppository)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78

Exclusion Criteria

•Bilateral ureteral stents to be inserted
•JJ stent already in situ prior to ureteroscopy
•Patients with congenital renal abnormalities (ie: horseshoe kidney, ectopic kidney, etc)
•Patients with urinary diversion
•Patients with a history of interstitial cystitis/painful bladder syndrome, chronic prostatitis, or neurogenic bladder.
•Indwelling foley catheter
•Urinary tract infection (urinalysis)
•Patients currently taking antimuscarinics, Mirabegron, or a-blockers
•Patients with contraindications to receive Mirabegron (ie: urinary retention, end-stage renal disease, orthostatic hypotension, uncontrolled hypertension, known QT prolongation, severe aortic regurgitation), significant cognitive impairment, pregnancy, and active urinary tract infection
•Suspected or confirmed ureteral perforation
•Placement of a JJ stent after an open procedure
•Uncontrolled Hypertension (SBP=180 mmHg and/or DBP=110mmHg)
•Patients with severe renal impairment concomitantly receiving strong CYP3A inhibitors
•Patients with severe hepatic impairment and patients with moderate hepatic impairment concomitantly receiving strong CYP3A inhibitors
•Patients with Bladder Outlet Obstruction (BOO)
•Patients with hypersensitivity in Mirabegron or to any of the following excipients: polyethyleneglycols, butylhydroxytoluene, magnesium stearate, hypromellose, Iron oxide yellow (E172)
•Participation in another interventional study one month before inclusion of the patient in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.;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).;Timepoint(s) of evaluation of this end point: end of subjects' follow up