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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks | Experimental | Single Group Assignment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INSTYLAN (Sodium Hyaluronate 80mg/50ml) | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| François SCHUTZE, PhD | Contact | +33 (0)6 83 54 01 42 | fr.schutze@liddetherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Marc FOURMARIER, MD | Aix en Provence Hospital Center (Aix en Provence) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aix en Provence Hospital Center | Recruiting | Aix-en-Provence | 13616 | France |
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| ID | Term |
|---|---|
| D000096722 | Cystitis, Hemorrhagic |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
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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 |
| Ajaccio Hospital Center (Notre Dame de la Miséricorde) | Recruiting | Ajaccio | 20167 | France |
|
| Polyclinic Sainte Marguerite (Auxerre) | Recruiting | Auxerre | 89000 | France |
|
| Clinic Rhône Durance (Avignon) | Recruiting | Avignon | 84000 | France |
|
| Cahors Hospital Center | Recruiting | Cahors | 46000 | France |
|
| Clinic of Val d'Ouest (Ecully) | Recruiting | Écully | 69130 | France |
|
| Mutualist Clinic Porte de l'Orient (Lorient) | Recruiting | Lorient | 56100 | France |
|
| Clinic Saint George (Nice) | Recruiting | Nice | 06000 | France |
|
| Saint Louis University Hospital Center (Paris) | Recruiting | Paris | 75010 | France |
|
| Regional University Hospital Center (Strasbourg) | Recruiting | Strasbourg | 67091 | France |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |