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

Hemorrhagic Cystitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04696666
• Other study ID #: CLIN-INST01F
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: January 2021
• Source: LIDDE Therapeutics
• Contact: François SCHUTZE, PhD
• Phone: +33 (0)6 83 54 01 42
• Email: fr.schutze[@]liddetherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cystitis
• Hemorrhagic Cystitis

Intervention

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.

Locations

Country	Name	City	State
France	Aix en Provence Hospital Center	Aix-en-Provence
France	Ajaccio Hospital Center (Notre Dame de la Miséricorde)	Ajaccio
France	Polyclinic Sainte Marguerite (Auxerre)	Auxerre
France	Clinic Rhône Durance (Avignon)	Avignon
France	Cahors Hospital Center	Cahors
France	Clinic of Val d'Ouest (Ecully)	Ecully
France	Mutualist Clinic Porte de l'Orient (Lorient)	Lorient
France	Clinic Saint George (Nice)	Nice
France	Saint Louis University Hospital Center (Paris)	Paris
France	Regional University Hospital Center (Strasbourg)	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
LIDDE Therapeutics

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	Evaluation of number of micturitions / 24 hours	Voiding diary sheet for each 24-hour period	Baseline, week 7 and week 10
Secondary	Evaluation of urgency of micturitions following a rating scale	Verbal rating scale (slight, moderate, important)	Baseline, week 7 and week 10