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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Aix en Provence Hospital Center
Aix-en-Provence, France
RECRUITINGAjaccio Hospital Center (Notre Dame de la Miséricorde)
Ajaccio, France
RECRUITINGChange 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
Time frame: 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
Time frame: Week 10
Evaluation of hematuria following a rating scale
Verbal rating scale of the colour of the urines: yellow, pink or red-brownish
Time frame: Baseline, week 7 and week 10
Evaluation of number of micturitions / 24 hours
Voiding diary sheet for each 24-hour period
Time frame: Baseline, week 7 and week 10
Evaluation of urgency of micturitions following a rating scale
Verbal rating scale (slight, moderate, important)
Time frame: Baseline, week 7 and week 10
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Polyclinic Sainte Marguerite (Auxerre)
Auxerre, France
Clinic Rhône Durance (Avignon)
Avignon, France
RECRUITINGCahors Hospital Center
Cahors, France
RECRUITINGClinic of Val d'Ouest (Ecully)
Écully, France
RECRUITINGMutualist Clinic Porte de l'Orient (Lorient)
Lorient, France
RECRUITINGClinic Saint George (Nice)
Nice, France
RECRUITINGSaint Louis University Hospital Center (Paris)
Paris, France
RECRUITINGRegional University Hospital Center (Strasbourg)
Strasbourg, France
RECRUITING