Assessment of the Interest of a Peri-operative Antibiotic Strategy Applied to Patients With Asymptomatic Bacteriuria Undergoing Intra-vesical Botulinum Toxin A Injections
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 526
- 试验地点
- 2
- 主要终点
- Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections.
研究概览
简要总结
The study aims to demonstrate that the "thrifty antibiotic strategy" applied to MS or SCI patients with asymptomatic bacteriuria prior to BoNTA intravesical injections does not increase the rate of symptomatic post-injection UTIs compared to the current peri-operative antibiotic strategy.
Patients included in the study will be randomized in two balanced-parallel groups, 4 days (+/- 2 days) before intra-vesical BoNTA injections.
Group 1: Experimental group: "Sparing antibiotic strategy" No antibiotic therapy will be administered during the peri-operative period.
Group 2: Control group: Recommendations - Peri-operative antibiotic strategy An antibiotic therapy will be administered during the peri-operative period. The antibiotic will be selected according to the type of bacteria isolated and the antibiotic susceptibility testing, and started two days before and pursued until two days following intra-vesical BoNTA injections.
The main objective is to demonstrate the non-inferiority of "antibiotic saving strategy" compared to peri-operative antibiotic strategy (current recommendations) for occurrence of symptomatic UTI after intra-vesical BoNTA injections in the management of asymptomatic bacteriuria (AB) among multiple sclerosis (MS) and spinal cord injured (SCI) patients undergoing clean intermittent self-catheterization (CISC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS or SCI (traumatic or non-traumatic)
- •Refractory OAB and/or DO (failure, intolerance or contra-indication to anti-muscarinic therapy)
- •Treated with intra-vesical botulinum toxin A injections having proved efficacy
- •CISC as the exclusive bladder management
- •AB on pre-operative urine analysis (performed 10 days (+/- 2 days) before intra-vesical BoNTA injections)
- •Exclusion of morphologic urinary tract abnormalities considered as a risk factor for recurrent symptomatic UTI.
排除标准
- •Having already participated to the study
- •Augmentation cystoplasty
- •Bladder compliance disorders (<20 mL/cmH2O)
- •Ongoing cyclic antibiotic therapy
- •Ongoing corticosteroid therapy
- •Modification of immunosuppressive or immunomodulatory therapy in the 3 months before inclusion (MS patients)
- •Antibiotic therapy in the month before inclusion
- •Surgical procedure in the 3 months before and the 6 weeks following inclusion
- •Symptomatic UTI at the time of inclusion
- •Associated neurologic disease
- •Pregnancy or breast feeding
- •Individuals especially in need of protection
- •No informed consent
- •Patients incapable to follow the trial, e.g. because of language problems, psychiatric disorders, dementia and so on
- •Immunocompromised patients
结局指标
主要结局
Rate of patients with symptomatic UTI occurring within the 6 weeks following the injections.
时间窗: During the 6 weeks following the injections
Symptomatic UTI will be defined according to the National Institute on Disability and Rehabilitation Research (NIDRR, 1992) as a significant bacteriuria with tissue invasion and resultant tissue response with signs and/or symptoms of UTI
次要结局
- Rate of patients with non-febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections(During the 6 weeks following the injections)
- Rate of patients with symptomatic UTI within the 6 weeks following BoNTA injections finally needing the administration of an antibiotic therapy.(During the 6 weeks following the injections)
- Rate of patients with complication (other than symptomatic UTI) related to* BoNTA injections occurring within the 6 weeks following the injections.(During the 6 weeks following the injections)
- Rate of patients with complication not related to** BoNTA injections occurring within the 6 weeks following the injections.(During the 6 weeks following the injections)
- Rate of patients with admission to an emergency unit not related** to BoNTA occurring within the 6 weeks following the injections(During the 6 weeks following the injections)
- Rate of patients with febrile symptomatic UTI occurring within the 6 weeks following BoNTA injections.occurring within the 6 weeks following the injections.(During the 6 weeks following the injections)
- Rate of patients with admission in a non-scheduled hospitalization related to* BoNTA injections occurring within the 6 weeks following the injections.(During the 6 weeks following the injections)
- Rate of patients with detrusor overactivity (non-voiding detrusor contractions during feeling phase)(6 weeks after BoNTA injections.)
- Identify risk factors of in-hospital postoperative symptomatic UTI(6 weeks after BoNTA injections.)
- Rate of patients with admission to an emergency unit related to* BoNTA injections occurring within the 6 weeks following the injections.(During the 6 weeks following the injections)
- Maximal cystometric capacity (MCC)(6 weeks after BoNTA injections.)
- Number of CISC per day(6 weeks after BoNTA injections.)
- Rate of patients with admission in a non-scheduled hospitalization not related to* BoNTA injections occurring within the 6 weeks following the injections.(During the 6 weeks following the injections)
- Number of urgency episodes per day(6 weeks after BoNTA injections.)
- Number of urinary incontinence episodes per day(6 weeks after BoNTA injections.)
- Functional bladder capacity(6 weeks after BoNTA injections.)