Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks Single Group Assignment |
Device: INSTYLAN (Sodium Hyaluronate 80mg/50ml)
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.
|
Outcome Measures
Primary Outcome Measures
- Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7 [Week 7]
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
- Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 10 [Week 10]
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
Secondary Outcome Measures
- Evaluation of hematuria following a rating scale [Baseline, week 7 and week 10]
Verbal rating scale of the colour of the urines: yellow, pink or red-brownish
- Evaluation of number of micturitions / 24 hours [Baseline, week 7 and week 10]
Voiding diary sheet for each 24-hour period
- Evaluation of urgency of micturitions following a rating scale [Baseline, week 7 and week 10]
Verbal rating scale (slight, moderate, important)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Males and females, at least 18 years,
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Patients who provided signed written informed consent, which includes compliance with requirements listed in the consent form,
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Patients with diagnosis of Hemorrhagic Cystitis,
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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:
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Patients with Post-void residual (PVR) urine volume > 200ml,
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Patients presently treated with intravesical treatment (replenishment therapy with glycosaminoglycans),
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Patients receiving HyperBaric Oxygen Therapy (HBOT),
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Patients with neurogenic bladder,
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Patients treated with neuromodulation techniques within the last six months,
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Patients undergoing or scheduled for radiation therapy, brachytherapy, chemotherapy or treatment with BCG or with Mitomycin-C,
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Patients suffering from lower urinary infections (UTIs),
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Patients with unstable cardiovascular disease,
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | |
| 5 | Cahors Hospital Center | Cahors | France | 46000 | |
| 6 | Clinic of Val d'Ouest (Ecully) | Ecully | France | 69130 | |
| 7 | Mutualist Clinic Porte de l'Orient (Lorient) | Lorient | France | 56100 | |
| 8 | Clinic Saint George (Nice) | Nice | France | 06000 | |
| 9 | Saint Louis University Hospital Center (Paris) | Paris | France | 75010 | |
| 10 | Regional University Hospital Center (Strasbourg) | Strasbourg | France | 67091 |
Sponsors and Collaborators
- LIDDE Therapeutics
Investigators
- Principal Investigator: Marc FOURMARIER, MD, Aix en Provence Hospital Center (Aix en Provence)
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLIN-INST01F