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

Last updated: April 17, 2025
Sponsor: Istituto Oncologico Veneto IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bladder Cancer

Urothelial Cancer

Treatment

Hydeal Cyst®

Clinical Study ID

NCT06245603
IOV-NMIBC-01-2022-HydealCyst
  • Ages > 18
  • All Genders

Study 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 4-6 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 12 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female ≥ 18 years of age

  • ECOG PS 0-2

  • Histologically confirmed diagnosis of non-muscle invasive bladder cancer, naïve andrecurrent.

  • Patients candidate to BCG or MMC intravesical induction therapy.

  • Transurethral resection (TURB) performed in the last 4 weeks.

  • IPSS score ≤10

  • Negative urine culture within 2 weeks before T0

  • For women who are not postmenopausal (i.e., < 1 year after last menstruation) orsurgical-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 inconjunction 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

Exclusion Criteria:

  • Upper urinary tract urothelial carcinoma (UTUC); bladder diverticula; urethralstenosis; difficult catheterization; reduced bladder compliance; increased bladdercompliance; post-voiding residue > 150 ml;

  • Surgery or invasive procedures planned during the study and interfering withevaluation about efficacy and safety of it.

  • Female patients with child-bearing potential must not be pregnant or lactating, ornot 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 investigationaldevice.

  • Neurogenic bladder

  • Any condition for that, in the opinion of the Investigator, participation would notbe in the best interest of the subject.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Hydeal Cyst®
Phase:
Study Start date:
December 20, 2024
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • Humanitas Gavezzeni-Bergamo

    Bergamo, 24125
    Italy

    Site Not Available

  • Ospedale Sant'Orsola - Malpighi

    Bologna,
    Italy

    Site Not Available

  • Policlinico Ospedali Riuniti - Foggia

    Foggia,
    Italy

    Active - Recruiting

  • Azienda Ospedale Università Padova

    Padova,
    Italy

    Active - Recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128
    Italy

    Active - Recruiting

  • Ospedali Riuniti Padova Sud

    Padova,
    Italy

    Active - Recruiting

  • Ospedale Santa Maria della Misericordia - ASU FC

    Udine,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata - Verona

    Verona,
    Italy

    Active - Recruiting

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