- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696666
Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis
Multicenter Clinical Study of 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
Study Overview
Status
Conditions
Intervention / Treatment
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 the physician. A total of 30 subjects are anticipated and will be enrolled in 10 study sites in France.
The patients will receive intravesical instillations with INSTYLAN weekly for 6 weeks.
The objectives of the study are to assess the efficacy of intravesical instillations of INSTYLAN on the basis of hemorrhagic cystitis symptoms disappearance. The primary endpoint is the evaluation of pain using a verbal rating scale one week and four weeks after treatment versus Baseline.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: François SCHUTZE, PhD
- Phone Number: +33 (0)6 83 54 01 42
- Email: fr.schutze@liddetherapeutics.com
Study Locations
-
-
-
Aix-en-Provence, France, 13616
- Recruiting
- Aix en Provence Hospital Center
-
Contact:
- Marc FOURMARIER Principal Investigator, MD
-
Ajaccio, France, 20167
- Recruiting
- Ajaccio Hospital Center (Notre Dame de la Miséricorde)
-
Contact:
- Sylvain DUCROCQ Investigator
-
Auxerre, France, 89000
- Recruiting
- Polyclinic Sainte Marguerite (Auxerre)
-
Contact:
- Nordine DEFFAR Investigator, MD
-
Avignon, France, 84000
- Recruiting
- Clinic Rhône Durance (Avignon)
-
Contact:
- Christophe CLEMENT Investigator, MD
-
Cahors, France, 46000
- Recruiting
- Cahors Hospital Center
-
Contact:
- Youssef BENTALEB Investigator, MD
-
Ecully, France, 69130
- Recruiting
- Clinic of Val d'Ouest (Ecully)
-
Contact:
- Arnaud CHERASSE Investigator, MD
-
Lorient, France, 56100
- Recruiting
- Mutualist Clinic Porte de l'Orient (Lorient)
-
Contact:
- Jean-Pierre GRAZIANA Investigator, MD
-
Nice, France, 06000
- Recruiting
- Clinic Saint George (Nice)
-
Contact:
- Yohann ROUSCOFF Investigator, MD
-
Paris, France, 75010
- Recruiting
- Saint Louis University Hospital Center (Paris)
-
Contact:
- François MEYER Investigator, MD
-
Strasbourg, France, 67091
- Recruiting
- Regional University Hospital Center (Strasbourg)
-
Contact:
- Christian SAUSSINE Investigator, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks
Single Group Assignment
|
The bladder instillation with INSTYLAN is a treatment involving a sterile solution of Sodium Hyaluronate (80mg/50ml) inserted into the bladder through a catheter and released after a short period of time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7
Time Frame: Week 7
|
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
|
Week 7
|
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 10
Time Frame: Week 10
|
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
|
Week 10
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of hematuria following a rating scale
Time Frame: Baseline, week 7 and week 10
|
Verbal rating scale of the colour of the urines: yellow, pink or red-brownish
|
Baseline, week 7 and week 10
|
Evaluation of number of micturitions / 24 hours
Time Frame: Baseline, week 7 and week 10
|
Voiding diary sheet for each 24-hour period
|
Baseline, week 7 and week 10
|
Evaluation of urgency of micturitions following a rating scale
Time Frame: Baseline, week 7 and week 10
|
Verbal rating scale (slight, moderate, important)
|
Baseline, week 7 and week 10
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marc FOURMARIER, MD, Aix en Provence Hospital Center (Aix en Provence)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLIN-INST01F
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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