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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemorrhagic Cystitis
• Intervention / Treatment: Device: INSTYLAN (Sodium Hyaluronate 80mg/50ml)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François SCHUTZE, PhD; Phone Number: +33 (0)6 83 54 01 42; Email: fr.schutze@liddetherapeutics.com

Study Locations

• France
  • Aix-en-Provence, France, 13616
    • Recruiting
    • Aix en Provence Hospital Center
    • Contact: Marc FOURMARIER Principal Investigator, MD
  • Ajaccio, France, 20167
    • Recruiting
    • Ajaccio Hospital Center (Notre Dame de la Miséricorde)
    • Contact: Sylvain DUCROCQ Investigator
  • Auxerre, France, 89000
    • Recruiting
    • Polyclinic Sainte Marguerite (Auxerre)
    • Contact: Nordine DEFFAR Investigator, MD
  • Avignon, France, 84000
    • Recruiting
    • Clinic Rhône Durance (Avignon)
    • Contact: Christophe CLEMENT Investigator, MD
  • Cahors, France, 46000
    • Recruiting
    • Cahors Hospital Center
    • Contact: Youssef BENTALEB Investigator, MD
  • Ecully, France, 69130
    • Recruiting
    • Clinic of Val d'Ouest (Ecully)
    • Contact: Arnaud CHERASSE Investigator, MD
  • Lorient, France, 56100
    • Recruiting
    • Mutualist Clinic Porte de l'Orient (Lorient)
    • Contact: Jean-Pierre GRAZIANA Investigator, MD
  • Nice, France, 06000
    • Recruiting
    • Clinic Saint George (Nice)
    • Contact: Yohann ROUSCOFF Investigator, MD
  • Paris, France, 75010
    • Recruiting
    • Saint Louis University Hospital Center (Paris)
    • Contact: François MEYER Investigator, MD
  • Strasbourg, France, 67091
    • Recruiting
    • Regional University Hospital Center (Strasbourg)
    • Contact: Christian SAUSSINE Investigator, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks; Single Group Assignment	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: LIDDE Therapeutics
• Investigators: Principal Investigator: Marc FOURMARIER, MD, Aix en Provence Hospital Center (Aix en Provence)

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2020
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): July 30, 2021

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (Actual): January 6, 2021

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Hemorrhagic cystitis
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: CLIN-INST01F

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No