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

NCT ID: NCT06245603

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2027-06-30

Brief Summary

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.

Conditions

Non-muscle Invasive Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A (interventional arm)

patients receive Hydeal Cyst intravesical instillations during the BCG or MMC therapy period.

Group Type: EXPERIMENTAL

Hydeal Cyst®

Intervention Type: DEVICE

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.

Arm B (control arm)

patients receive only standard therapy (BCG or MMC).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hydeal Cyst®

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female ≥ 18 years of age
• ECOG PS 0-2
• Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve and recurrent.
• Patients candidate to BCG or MMC intravesical induction therapy.
• Transurethral resection (TURB/re-TURB when indicated) performed in the last 12 weeks.
• IPSS score ≤19
• Negative urine culture within 2 weeks before T0
• For women who are not postmenopausal (i.e., < 1 year after last menstruation) or surgical-ly sterile (absence of ovaries and/or uterus) and who are sexually active: agreement to use an adequate method of contraception (oral contraceptives, intrauterine contraceptive de-vice, or barrier method of contraception in conjunction with spermicidal jelly) during the study period
• Signed the study informed consent prior to any study specific procedures.
• Will and ability to comply with the protocol

Exclusion Criteria

• Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethral stenosis; difficult catheterization; reduced bladder compliance; increased bladder compliance; post-voiding residue > 150 ml;
• Surgery or invasive procedures planned during the study and interfering with evaluation about efficacy and safety of it.
• Female patients with child-bearing potential must not be pregnant or lactating, or not willing to use adequate contraception for the duration of study
• Pelvic radiotherapy within 24 weeks prior to the beginning of the study treatment.
• Urinary tract infection requiring antibiotics
• Have a known hypersensitivity to any substance present in the investigational device.
• Neurogenic bladder
• Any condition for that, in the opinion of the Investigator, participation would not be in the best interest of the subject.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fidia Farmaceutici s.p.a.

INDUSTRY

Sponsor Role: collaborator

Istituto Oncologico Veneto IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Humanitas Gavezzeni-Bergamo

Bergamo, , Italy

Site Status: RECRUITING

Ospedale Sant'Orsola - Malpighi

Bologna, , Italy

Site Status: NOT_YET_RECRUITING

Policlinico Ospedali Riuniti - Foggia

Foggia, , Italy

Site Status: RECRUITING

Istituto Oncologico Veneto IRCCS

Padua, , Italy

Site Status: RECRUITING

Azienda Ospedale Università Padova

Padua, , Italy

Site Status: RECRUITING

Ospedali Riuniti Padova Sud

Padua, , Italy

Site Status: RECRUITING

Policlinico Paolo Giaccone

Palermo, , Italy

Site Status: RECRUITING

Ospedale Santa Maria della Misericordia - ASU FC

Udine, , Italy

Site Status: RECRUITING

Azienda Ospedaliera Universitaria Integrata - Verona

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Amodeo, MD

Role: CONTACT

antonio.amodeo@iov.veneto.it

0423 421321 ext. +39

Gian Luca De Salvo, MD

Role: CONTACT

gianluca.desalvo@iov.veneto.it

049 8215710 ext. +39

Facility Contacts

Angelo Porreca, MD

Role: primary

angelo.porreca@hunimed.eu

0354204500 ext. +39

Francesco Chessa, MD

Role: primary

francesco.chessa@aosp.bo.it

0512142545 ext. +39

Gian Maria Busetto, MD

Role: primary

gianmaria.busetto@unifg.it

Antonio Amodeo, MD

Role: primary

antonio.amodeo@iov.veneto.it

0423 421321 ext. +39

Gian Luca De Salvo, MD

Role: backup

gianluca.desalvo@iov.veneto.it

049 8215710 ext. +39

Fabrizio Dal Moro, MD

Role: primary

fabrizio.dalmoro@unipd.it

0498218599 ext. +39

Nicola Zanovello, MD

Role: primary

nicola.zanovello@aulss6.veneto.it

0429715516 ext. +39

Nicola Pavan, Prof

Role: primary

nicola.pavan@unipa.it

Alessandro Crestani, MD

Role: primary

alessandro.crestani@asufc.sanita.fvg.it

0432552931 ext. +39

Alessandro Antonelli, MD

Role: primary

alessandro.antonelli@aovr.veneto.it

0458127702/03 ext. +39

Other Identifiers

IOV-NMIBC-01-2022-HydealCyst

Identifier Type: -

Identifier Source: org_study_id