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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Hemorrhagic Cystitis

Intervention / Treatment
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* Device: INSTYLAN (Sodium Hyaluronate 80mg/50ml)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: It is a multicenter single-arm clinical study aimed at assessing the efficacy and tolerability of INSTYLAN (Sodium Hyaluronate 80mg/50ml) provided in routine clinical practice in patients presenting with symptoms of moderate to severe hemorrhagic cystitis.
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<br>Single Group Assignment | Device: INSTYLAN (Sodium Hyaluronate 80mg/50ml)<br>* 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.<br>|

What is the study measuring?
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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 | 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 | 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 | 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 | Voiding diary sheet for each 24-hour period | Baseline, week 7 and week 10 | 
| Evaluation of urgency of micturitions following a rating scale | Verbal rating scale (slight, moderate, important) | Baseline, week 7 and week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhagic cystitis