UnknownNot Applicable

Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis

France30 participantsStarted 2020-05-15

Plain-language summary

The purpose of this study is to assess the efficacy and tolerability of INSTYLAN (Sodium Hyaluronate 80mg/50ml) in Patients with early or late symptoms of moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy. The study is conducted in the field of routine clinical practice and will recruit 30 subjects treated with intravesical instillations with INSTYLAN weekly for 6 weeks.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Males and females, at least 18 years, * Patients who provided signed written informed consent, which includes compliance with requirements listed in the consent form, * Patients with diagnosis of Hemorrhagic Cystitis, * Patients with diagnosis of bladder pain (pressure or pelvic discomfort) with at least one other urinary symptom (need to urinate right away (urgency), often (frequency), or both). Exclusion Criteria: * Patients with Post-void residual (PVR) urine volume \> 200ml, * Patients presently treated with intravesical treatment (replenishment therapy with glycosaminoglycans), * Patients receiving HyperBaric Oxygen Therapy (HBOT), * Patients with neurogenic bladder, * Patients treated with neuromodulation techniques within the last six months, * Patients undergoing or scheduled for radiation therapy, brachytherapy, chemotherapy or treatment with BCG or with Mitomycin-C, * Patients suffering from lower urinary infections (UTIs), * Patients with unstable cardiovascular disease, * Patients with any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7

Timeframe: Week 7

Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 10

Timeframe: Week 10

Trial details

NCT IDNCT04696666

SponsorLIDDE Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05-30

Contact for this trial

François SCHUTZE, PhD

+33 (0)6 83 54 01 42 fr.schutze@liddetherapeutics.com

View on ClinicalTrials.gov More Hemorrhagic Cystitis trials