EUCTR2015-004013-25-GR进行中（未招募）1 期
Mirabegron in the management of lower urinary tract symptoms (LUTS) related to double-J (JJ) ureteral stents. - BET-JJ
Institute of Molecular Medicine and Biomedical Research- I.M.B.E.0 个研究点开始时间: 2016年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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