Clinical trial · Interventional
Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT
Intravesically Heated Thermo-chemotherapy With Mitomycin-C Prior to TURBT- Prospective Controlled Study
- 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)
Transurethral Resection of Bladder Tumor (TURBT) is the initial treatment procedure for urinary bladder cancer. Recurrence rate during the first year ranges between 15-38% in case of low-intermediate disease. Current literature advocate using intravesical instillations of Mitomycin-C (MMC) immediately post TURBT in order to reduce the rate of recurrence. During the last decade, heated intravesical instillations have emerged as additional players, in the treatment of recurrent disease. By most cases, the heated intravesical instillations are given either by microwave hyperthermia (synergo®) or by conductive heat bladder wall thermo-chemotherapy (BWT). Previous reports suggest up to 59% reduction rate in recurrence following thermo-chemotherapy upon recurrent disease. These outstanding reduction results haven't convinced significant amount of urologists worldwide to use the intravesical instillation close after endoscopic resection as TURBT, probably due to the fear of MMC adverse effects in an operated area or the fear of complications due to perforated bladder. Preliminary results have suggested favourable outcome when MMC is used prior to TURBT \[see publication\]. To the investigators' knowledge no previous study has prospectively examined the effect of preliminary heated intravesical installation with BWT.
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 |
|---|---|---|---|
| Transitional Cell Carcinoma | Transitional Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BWT with Mitomycin-C prior TURBT | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- TURBT ONLY
- description
- A total of 150 patients in this arm will be divided into five follow-up sub groups according to pathology reports. Group 1 - Primary Low risk patients Group 2 - Primary Intermediate risk patients Group 3 - Primary High risk patients Group 4 - Recurrent Intermediate risk patients Group 5 - Recurrent Intermediate risk patients
- type
- EXPERIMENTAL
- label
- BWT with Mitomycin-C prior TURBT
- description
- A total of 150 patients in this arm will be divided into five follow-up sub groups according to pathology reports. Group 1 - Primary Low risk patients Group 2 - Primary Intermediate risk patients Group 3 - Primary High risk patients Group 4 - Recurrent Intermediate risk patients Group 5 - Recurrent Intermediate risk patients
- interventionNames
- Other: BWT with Mitomycin-C prior TURBT
Primary outcomes (1)
- measure
- Recurrence rate of Urothelial carcinoma (UC) of bladder
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients (\>18 yrs.) with good performance status according to Eastern Cooperative Oncology Group (ECOG) scale, designed to TURBT and gave their consent to participate in our research. 2. All participants must have adequate blood tests (CBC, Creatinine, electrolytes and liver function tests). Exclusion Criteria: 1. Concurrent other malignancy in the urinary system (e.g. upper tract UC) 2. Urothelial malignancy of the bladder other then carcinoma 3. Diffuse carcinoma in situ on preliminary cystoscopy 4. Allergy or sensitivity to MMC 5. Known urinary bladder capacity of less then 200cc 6. Concurrent complicated urinary infection 7. Autoimmune disease or patient under immunosuppressive therapy 8. presence of urethral stricture 9. Previous pelvic radiotherapy 10. Concomitant malignancy of other organ 11. Pregnancy 12. Children under 18 years.
References
Publications (1)
- BACKGROUNDDi Stasi SM, Valenti M, Verri C, Liberati E, Giurioli A, Leprini G, Masedu F, Ricci AR, Micali F, Vespasiani G. Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial. Lancet Oncol. 2011 Sep;12(9):871-9. doi: 10.1016/S1470-2045(11)70190-5. Epub 2011 Aug 8. PMID 21831711