Actively Recruiting
A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer
Led by Istituto Oncologico Veneto IRCCS · Updated on 2026-02-06
200
Participants Needed
9
Research Sites
26 weeks
Total Duration
On this page
Sponsors
I
Istituto Oncologico Veneto IRCCS
Lead Sponsor
F
Fidia Farmaceutici s.p.a.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of Hydeal Cyst® intravesical instillations in patients with non-muscle invasive bladder cancer who are treated with intravesical chemotherapy or immunotherapy. This study compares patients receiving Hydeal Cyst along with standard therapy to those receiving only standard therapy, aiming to understand its impact on symptoms and quality of life. Participants must meet specific health criteria and sign informed consent before enrollment. The study involves two groups: one receives Hydeal Cyst intravesical instillations during BCG or MMC therapy, and the other receives only the standard BCG or MMC therapy. BCG or MMC treatment starts within 1-2 weeks after randomization and is given once a week by intravesical instillation for 6 weeks (BCG) or 8 weeks (MMC). Patients in the Hydeal Cyst group receive additional instillations 48 hours after each standard treatment, totaling 6 for BCG and 8 for MMC. Participants undergo various assessments including physical exams, symptom evaluations, urine cultures, and questionnaires about urinary symptoms and quality of life at multiple points during and after treatment. Follow-up visits occur 6 and 18 weeks after therapy ends to monitor symptoms, perform cystoscopy and urine cultures, and evaluate quality of life. The primary outcome is the measurement of lower urinary tract symptoms from randomization up to 22 weeks, with additional outcomes including recurrence-free survival, progression-free survival, toxicity, and quality of life.
CONDITIONS
Brief Title
A Study to Evaluate Efficacy and Safety of Hydeal Cyst® Intravesical Instillations in Patients Treated With Intravesical Chemotherapy or Immunotherapy in Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- ECOG performance status 0 to 2
- Histologically confirmed non-muscle invasive bladder cancer, new or recurrent
- Candidate for BCG or MMC intravesical induction therapy
- Transurethral resection (TURB/re-TURB when indicated) performed within the last 12 weeks
- International Prostate Symptom Score (IPSS) of 19 or less
- Negative urine culture within 2 weeks before treatment start
- For women of childbearing potential: agreement to use adequate contraception during the study
- Signed informed consent before any study procedures
- Willingness and ability to comply with the study protocol
You will not qualify if you...
- Upper urinary tract urothelial carcinoma (UTUC), bladder diverticula, urethral stenosis, difficult catheterization, or abnormal bladder compliance
- Post-voiding residual urine volume greater than 150 ml
- Planned surgery or invasive procedures that interfere with study evaluation
- Pregnant or lactating women not willing to use contraception
- Pelvic radiotherapy within 24 weeks prior to treatment
- Urinary tract infection requiring antibiotics
- Known allergy to any substance in the investigational device
- Neurogenic bladder
- Any condition deemed by the investigator to make participation not in the subject's best interest
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 to 8 weeks
Participants receive BCG or MMC intravesical instillation therapy once a week for 6 weeks (BCG) or 8 weeks (MMC). Participants in Arm A also receive Hydeal Cyst intravesical instillations 48 hours after each BCG or MMC instillation during the treatment period.
Weekly visits for 6 to 8 weeks
Trial Site Locations
Total: 9 locations
1
Humanitas Gavezzeni-Bergamo
Bergamo, Italy, 24125
Actively Recruiting
2
Ospedale Sant'Orsola - Malpighi
Bologna, Italy
Not Yet Recruiting
3
Policlinico Ospedali Riuniti - Foggia
Foggia, Italy
Actively Recruiting
4
Istituto Oncologico Veneto IRCCS
Padova, Italy, 35128
Actively Recruiting
5
Azienda Ospedale Università Padova
Padova, Italy
Actively Recruiting
6
Ospedali Riuniti Padova Sud
Padova, Italy
Actively Recruiting
7
Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
8
Ospedale Santa Maria della Misericordia - ASU FC
Udine, Italy
Actively Recruiting
9
Azienda Ospedaliera Universitaria Integrata - Verona
Verona, Italy
Actively Recruiting
Research Team
A
Antonio Amodeo, MD
G
Gian Luca De Salvo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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