The Aim of This Study is to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer

NCT04671407 | Unknown Phase 2

• 1 other identifier: Kaplan
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: to demonstrate a 10% recurrence risk reduction for patients treated with Hypersal versus normal saline immediately following TURBT. Design: prospective randomized double-blind placebo controlled trial. Outline: eligible patients with non-muscle invasive bladder cancer who undergo TURBT at our center will be randomized to receive either 40ml of normal saline or 40 ml of hypersal intravesically. The primary endpoint is tumor recurrence rate. Secondary endpoint are time to recurrence and side effects. Patients A total of 150 patients will be enrolled in this trial.

Conditions

TCC

Outcome Measures

Primary Outcomes (1)

• EFFICACY

  All patients will be followed for one year after recruitment. During this one year period patients will undergo surveillance cystoscopy at 3 months, 6 months and 1 year following enrollment. Time to recurrence will be defined as the number of days from TURBT to recurrence at follow up cystoscopy.

  24 month E

Study Arms (2)

CONTROL

ACTIVE COMPARATOR

40ml of hypersal saline (3% NaCl) will be administered to bladder the after the surgery

Drug: Hypertonic Saline

PLACEBO

PLACEBO COMPARATOR

40ml of normal saline (0.9% NaCl) will be administered to bladder the after the surgery

Drug: Hypertonic Saline

Interventions

Hypertonic Saline DRUG

Hypertonic Saline 3% and 0.9%

CONTROL; PLACEBO

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. Previous diagnosis of urothelial carcinoma 2. Solid tumors or larger than 3 cm in diameter 3. Any patient with concurrent upper tract TCC by either imaging or endoscopy 4. Patients with preoperative hypernatremia \>145 meq/dl 5. Patients with preoperative renal failure serum creatinine level \>2.5 mg / dl 6. Patients with indwelling double J stents or when such a stent is inserted during the TURBT
• Abortion Criteria:
• Resections that mandate CBI (continuous bladder irrigation)
• Incomplete resections / endoscopic appearance of MIBC
• Suspected bladder perforation

Sponsors & Collaborators

• Kaplan Medical Center: lead

Study Sites (1)

Kaplan MC

Rehovot, Israel

RECRUITING

MeSH Terms

Interventions

Saline Solution, Hypertonic

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized controlled double-blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled double-blind

Study Record Dates

• First Submitted: November 29, 2020
• First Posted: December 17, 2020
• Study Start: January 20, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 18, 2021

Record last verified: 2020-12

Locations

IL (1)