An interventional study of Hydeal Cyst® in Non-muscle Invasive Bladder Cancer, sponsored by Istituto Oncologico Veneto IRCCS. Recruiting at 9 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Istituto Oncologico Veneto IRCCS · Not applicable, Interventional, and Treatment
Prior to performing any study specific procedure (including screening procedures to determine eligibility), a signed consent form will be obtained for each subject. Patients will be enrolled in the study only if they meet all the inclusion criteria and none of the exclusion criteria.
Prior to perform any study specific procedure (including screening procedures to determine eligibility), a signed informed consent form will be obtained for each subject. The informed consent form will describe the purpose of the study, the procedures to be followed, and the risk and benefits of participation. The investigator will conduct the informed consent discussion and will check that the subject comprehends the information provided and will answers any questions about the study. Consent will be voluntary and free from coercion. The investigator that will conduct the consent discussion will also sign the informed consent form. A copy of the informed consent form will be given to the subject and the fact that the subject has been consented to the study will be documented in the subject's record. When all the inclusion and exclusion criteria have been addressed and the eligibility of the subject confirmed, the subject may be enrolled in the study.
The following activities and/or assessments will be performed during screening, prior the treatment period start: demographic, medications related to the disease or symptoms and cancer history data collection; Urine-colture; randomization; Questionnaires QoL e IPSS.
BCG or MMC will be started within 1-2 weeks from randomization (within 12-14 weeks after TURB).
BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment.
48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation.
BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation.
After 2 weeks from BCG or MMC instillation end, IPSS e QoL questionaires will be administered and a control urino-colture will be executed.
After 6 and 18 weeks from instillation therapy end, a control visit will be made.
A physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes.
Control cystoscopy and urino-colture will be executed (as for clinical practice) and IPSS and quality of life evaluated.
Exclusion Criteria:
patients receive Hydeal Cyst intravesical instillations during the BCG or MMC therapy period.
Device: Hydeal Cyst®
patients receive only standard therapy (BCG or MMC).
BCG or MMC will be started within 1-2 weeks from randomization (within 12-14 weeks after TURB). BCG or MMC will be administered once a week by intravesical instillation: BCG will be abministered for 6 weeks and MMC for 8 weeks. (induction cycles) Before instillations a physical examination will be performed and symptoms evaluated: changes from baseline and abnormalities will be recorded in patient notes. IPSS questionnaire and QoL questionaire will be administered to the patient at week 1, 4 and 6/8 (6 for BCG and 8 for MMC) of treatment. 48 hours after post BCG or MMC intravesical instillation, patients of Arm A will undergo Hydeal Cyst intravesical instillation. BCG patiens will received 6 Hydeal Cyst intravesical instillation; MMC patiens will received 8 Hydeal Cyst intravesical instillation.
Lower urinary tract symptoms
Lower urinary tract symptoms will be evaluated by the IPSS questionnaire (score 0-35) at baseline and follow-up visits. Difference from baseline will be calculated at two weeks after the end of induction cycle of intravesical instillation.
Time frame: From the date of randomization up to 22 weeks
Recurrence free survival (RFS)
The recurrence free survival (RFS) will be determined as the time from the date of randomization to the date of clinical disease recurrence. Patients without a RFS event at the time of analysis will be censored at the date of last assessment
Time frame: From the date of randomization up to 22 weeks
Progression free survival (PFS)
The progression free survival (PFS) will be determined as the time from the date of randomization to the date of clinical disease progression. Patients without a PFS event at the time of analysis will be censored at the date of last assessment
Time frame: From the date of randomization up to 22 weeks
Toxicity during the treatment
Toxicity during the treatment will be recorded and graded according to the NCI-Common Terminology Criteria for Adverse Events (CTCAE) v.5. Grade refers to the severity of the adverse event. A grading (severity) scale is provided for each adverse event term. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE.
Time frame: From the date of randomization up to 22 weeks
Quality of Life assessment
Quality of Life will be evaluated at randomization (T0), at weeks 4 and 6/8 (T6 for BCG/T8 for MMC) of instillation treatment and during follow-up period (weeks 2, 6 and 12 after instillation treatment end). QoL will be assessed throught the FACT-Bl questionnaire.
Time frame: From the date of randomization up to 22 weeks
Plan to share: No
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Non-Muscle Invasive Bladder Neoplasms→
Istituto Oncologico Veneto IRCCS