Health Condition 1: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Intravesical BCG instillation with Oral Sodium Bicarbonate: 4 gm oral sodium bicarbonate tablets starting 2 hours prior to each intravesical BCG instillation (80 mg) during induction ph
Sponsors
All India Institute of Medical Sciences Bhubaneswar
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Subsequent : Before each intravesical BCG instillation and after 48 hours of each intravesical therapy( 6 instillations in total) | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the quality of life of patients receiving co-administration of oral sodium bicarbonate with intravesical BCG instillation Vs Intravesical BCG alone therapy for non-muscle-invasive bladder cancer assessed by ICIQ-LUTSqol questionnaire at the end of induction period of 6 weeks.Timepoint: 1.Baseline : Before Starting BCG Therapy 2.Two days after completion of induction phase ( 6 instillations)of BCG therapy ;To determine the effect of administration of oral sodium bicarbonate on efficacy of intravesical BCG instillation in preventing tumour recurrence in patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) assessed by cystoscopy.Timepoint: 12 weeks after starting BCG therapy;To determine the safety of co-administration of oral sodium bicarbonate with intravesical BCG instillation in patients of non-muscle-invasive bladder cancer (Adverse events reporting and classification according CTCAE v5) during the induction period of 6 weeks.Timepoint: During the 6 weeks if induction phase of BCG therapy | — |
Countries
India
Contacts
Public ContactSantosh K
All India Institute of Medical Sciences, Bhubaneswar
Outcome results
None listed