Clinical trial NCT04696666: Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemorrhagic Cystitis
Keywords: Hemorrhagic cystitis
Lead sponsor: LIDDE Therapeutics
Sponsor class: INDUSTRY
First posted: 2021-01-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7
timeFrame: Week 7
measure: Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 10
timeFrame: Week 10
Secondary outcomes:
measure: Evaluation of hematuria following a rating scale
timeFrame: Baseline, week 7 and week 10
measure: Evaluation of number of micturitions / 24 hours
timeFrame: Baseline, week 7 and week 10
measure: Evaluation of urgency of micturitions following a rating scale
timeFrame: Baseline, week 7 and week 10
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Aix en Provence Hospital Center
city: Ajaccio
country: France
facility: Ajaccio Hospital Center (Notre Dame de la Miséricorde)
city: Auxerre
country: France
facility: Polyclinic Sainte Marguerite (Auxerre)
city: Avignon
country: France
facility: Clinic Rhône Durance (Avignon)
city: Cahors
country: France
facility: Cahors Hospital Center
city: Ecully
country: France
facility: Clinic of Val d'Ouest (Ecully)
city: Lorient
country: France
facility: Mutualist Clinic Porte de l'Orient (Lorient)
city: Nice
country: France
facility: Clinic Saint George (Nice)
city: Paris
country: France
facility: Saint Louis University Hospital Center (Paris)
city: Strasbourg
country: France
facility: Regional University Hospital Center (Strasbourg)
Study officials:
affiliation: Aix en Provence Hospital Center (Aix en Provence)
name: Marc FOURMARIER, MD
role: PRINCIPAL_INVESTIGATOR
References: