Role of oral Sodium Bicarbonate in the reduction of intravesical BCG induced lower urinary tract symptoms: A prospective randomized controlled trial.

All India Institute of Medical Sciences Bhubaneswar0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.All consented cases of intermediate- and high-risk(European association of urology classification) non-muscle-invasive urothelial carcinomas scheduled for intravesical BCG instillations.

•1.Contraindications to BCG therapy.
•Absolute contraindications include: Immunocompromised patients, Personal history of BCG sepsis, Gross hematuria, Traumatic catheterization, Total incontinence
•Relative contraindications: Urinary tract infection, Liver disease, Personal history of tuberculosis, Poor overall performance status.
•2.Previous BCG or chemotherapy instillation.
•3.Variant histology of urothelial carcinoma.
•4.Subjects with concurrent urinary tract infections.
•5.Post void residual (PVR) urine volume > 1/3 of the pre-void volume.
•6.History of clinically significant drug hypersensitivity to BCG or antacids containing bicarbonate.
•7.Already on another pharmacologic agent used to treat symptoms of LUTS.
•8.Aggravated CHF, Pedal edema and volume overload, Hypernatremia, Hypocalcemia, Hypokalemia, chronic kidney disease and Pulmonary edema.
•9.Participation in any other clinical study within 1 month prior to screening that may affect urinary function.
•10.Pregnant or breastfeeding women.

发起方

All India Institute of Medical Sciences Bhubaneswar