Clinical trial · Interventional
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
Randomized Controlled Double-blind Phase II Study to Compare the Efficacy of Perioperative Hypertonic Saline 3% Versus Normal Saline (0.9%) in Decreasing Recurrence Risk in Non-muscle Invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| TCC | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypertonic Saline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CONTROL
- description
- 40ml of hypersal saline (3% NaCl) will be administered to bladder the after the surgery
- interventionNames
- Drug: Hypertonic Saline
- type
- PLACEBO_COMPARATOR
- label
- PLACEBO
- description
- 40ml of normal saline (0.9% NaCl) will be administered to bladder the after the surgery
- interventionNames
- Drug: Hypertonic Saline
Primary outcomes (1)
- measure
- EFFICACY
- timeFrame
- 24 month E
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Age ≥18 years, men and women who are scheduled for TURBT at our center 2. Newly diagnosed papillary bladder tumors \< 3cm in largest diameter at cystoscopy 3. Normal upper tracts as determined by CTU/MRU either during the 1 year before TURBT of done within one month after TURBT 4. Serum creatinine level ≤ 2.5 mg / dl before inclusion 5. Serum sodium level \<145 meq/ dl before inclusion Exclusion Criteria: * 1\. 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: 1. Resections that mandate CBI (continuous bladder irrigation) 2. Incomplete resections / endoscopic appearance of MIBC 3. Suspected bladder perforation
References
Publications (0)
Data not yet available