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New device aims to calm bladder irritation during cancer therapy

NCT ID NCT06245603

Symptom relief Sponsor: Istituto Oncologico Veneto IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times

Summary

This study tests whether adding Hydeal Cyst® instillations can reduce lower urinary tract symptoms in people receiving standard chemotherapy or immunotherapy for non-muscle invasive bladder cancer. About 200 participants will receive either BCG or MMC, and half will also get Hydeal Cyst®. The main goal is to see if symptoms improve, measured by a questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Hydeal Cyst® (a device used as an intravesical instillation)
What this could lead to
If it works, this could provide a way to reduce urinary discomfort during standard bladder cancer therapy.
What could go wrong
This is an early-stage study with no phase designation, so results are uncertain. The device is tested alongside standard treatments, not as a replacement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-muscle invasive bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedale Università Padova

    RECRUITING

    Padova, Italy

  • Azienda Ospedaliera Universitaria Integrata - Verona

    RECRUITING

    Verona, Italy

  • Humanitas Gavezzeni-Bergamo

    RECRUITING

    Bergamo, 24125, Italy

  • Istituto Oncologico Veneto IRCCS

    RECRUITING

    Padova, 35128, Italy

  • Ospedale Sant'Orsola - Malpighi

    NOT_YET_RECRUITING

    Bologna, Italy

  • Ospedale Santa Maria della Misericordia - ASU FC

    RECRUITING

    Udine, Italy

  • Ospedali Riuniti Padova Sud

    RECRUITING

    Padova, Italy

  • Policlinico Ospedali Riuniti - Foggia

    RECRUITING

    Foggia, Italy

  • Policlinico Paolo Giaccone

    RECRUITING

    Palermo, 90127, Italy

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