Intravesical Ialuril® plus oral combination of curcumine, quercetine, hyluronic acid (HA) and chondroitin sulphate (CS) for prophylaxis of recurrent non-muscle invasive transitional cell carcinoma (TCC) of the bladder

Intravesical Ialuril® plus oral combination of curcumine, quercetine, hyluronic acid (HA) and chondroitin sulphate (CS) for prophylaxis of recurrent non-muscle invasive transitional cell carcinoma (TCC) of the bladder: a prospective longitudinal investigative pilot non-randomised study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45836359

Enrollment

Registered

2013-03-20

Start date

2012-01-01

Completion date

Unknown

Last updated

2019-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial (non muscle invasive) transitional cell carcinoma Cancer

Interventions

All the patients underwent standard transurethral resection of the visible lesions. Immediate post-TURBT intravesical instillation of a combination of HA and CS (Ialuril®: 50 ml/vial solution containi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients (male and female) with single, ultrasound detected < 3 cm tumor diameter, or multiple 3 or less, each < 1 cm, low- and intermediate-grade (Grade II in old nomenclature) superficial TCC at the first diagnosis, confirmed by flexible cystoscopy and cold cup biopsy

Exclusion criteria

Exclusion criteria: 1. Concomitant CIS 2. Involvement of the prostatic urethra 3. Neurogenic bladder 4. Diabetes mellitus type I and II 5. Previous bladder or prostate surgery (any kind) 6. Previous treatment with drugs (capsaicin, vanilloids, ovanil, botulinum toxin etc) 7. Further exclusion criteria were previous chemotherapies and/or pelvic radiotherapy

Design outcomes

Primary

Measure	Time frame
1. Tolerability, reported as discontinuation or deviation of the protocol and safety as general or local side effects 2. Efficacy, defined as the absence of recurrence as defined by negative ultrasound evaluation, negative urine cytology and negative endoscopic assessment after 3 months	—

Secondary

Measure	Time frame
Morphological immunohistochemical assessment, comparing samples at entry and after 3 months for transient receptor protein vanilloids 1 (TRPV1) expression and GAGs	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026