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