Status:
UNKNOWN
Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis
Lead Sponsor:
LIDDE Therapeutics
Conditions:
Hemorrhagic Cystitis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 cause...
Detailed Description
This is a multicenter single-arm clinical study including male and female subjects with moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy as determined by ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04696666
Start Date
May 15 2020
End Date
July 30 2021
Last Update
January 6 2021
Active Locations (10)
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1
Aix en Provence Hospital Center
Aix-en-Provence, France, 13616
2
Ajaccio Hospital Center (Notre Dame de la Miséricorde)
Ajaccio, France, 20167
3
Polyclinic Sainte Marguerite (Auxerre)
Auxerre, France, 89000
4
Clinic Rhône Durance (Avignon)
Avignon, France, 84000