se of sodium bicarbonate to decrease the discomfort caused by BCG treatment for bladder cancer

Phase 4

Conditions: Health Condition 1: N33- Bladder disorders in diseases classified elsewhere

Registration Number: CTRI/2020/11/029091

Lead Sponsor: All India Institute of Medical Sciences Bhubaneswar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the proportion of patients experiencing intravesical BCG induced Lower Urinary Tract Symptoms (LUTS) in those receiving oral sodium bicarbonate with BCG instillation vs BCG alone therapy for non-muscle-invasive bladder cancer during the induction period of 6 weeks (Assessed by using Bladder diary and OAB-V8 questionnaire).Timepoint: Baseline : before starting therapy <br/ ><br> <br/ ><br>Subsequent : Before each intravesical BCG instillation and after 48 hours of each intravesical therapy( 6 instillations in total)

Secondary Outcome Measures