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

Primary Purpose

Hemorrhagic Cystitis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
INSTYLAN (Sodium Hyaluronate 80mg/50ml)
Sponsored by
LIDDE Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Cystitis focused on measuring Hemorrhagic cystitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks

Arm Description

Single Group Assignment

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Evaluation of hematuria following a rating scale
Verbal rating scale of the colour of the urines: yellow, pink or red-brownish
Evaluation of number of micturitions / 24 hours
Voiding diary sheet for each 24-hour period
Evaluation of urgency of micturitions following a rating scale
Verbal rating scale (slight, moderate, important)

Full Information

First Posted
January 3, 2021
Last Updated
January 5, 2021
Sponsor
LIDDE Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT04696666
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LIDDE Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Cystitis
Keywords
Hemorrhagic cystitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks
Arm Type
Experimental
Arm Description
Single Group Assignment
Intervention Type
Device
Intervention Name(s)
INSTYLAN (Sodium Hyaluronate 80mg/50ml)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7
Description
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
Time Frame
Week 7
Title
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 10
Description
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
Time Frame
Week 10
Secondary Outcome Measure Information:
Title
Evaluation of hematuria following a rating scale
Description
Verbal rating scale of the colour of the urines: yellow, pink or red-brownish
Time Frame
Baseline, week 7 and week 10
Title
Evaluation of number of micturitions / 24 hours
Description
Voiding diary sheet for each 24-hour period
Time Frame
Baseline, week 7 and week 10
Title
Evaluation of urgency of micturitions following a rating scale
Description
Verbal rating scale (slight, moderate, important)
Time Frame
Baseline, week 7 and week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François SCHUTZE, PhD
Phone
+33 (0)6 83 54 01 42
Email
fr.schutze@liddetherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc FOURMARIER, MD
Organizational Affiliation
Aix en Provence Hospital Center (Aix en Provence)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aix en Provence Hospital Center
City
Aix-en-Provence
ZIP/Postal Code
13616
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc FOURMARIER Principal Investigator, MD
Facility Name
Ajaccio Hospital Center (Notre Dame de la Miséricorde)
City
Ajaccio
ZIP/Postal Code
20167
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain DUCROCQ Investigator
Facility Name
Polyclinic Sainte Marguerite (Auxerre)
City
Auxerre
ZIP/Postal Code
89000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nordine DEFFAR Investigator, MD
Facility Name
Clinic Rhône Durance (Avignon)
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe CLEMENT Investigator, MD
Facility Name
Cahors Hospital Center
City
Cahors
ZIP/Postal Code
46000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Youssef BENTALEB Investigator, MD
Facility Name
Clinic of Val d'Ouest (Ecully)
City
Ecully
ZIP/Postal Code
69130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud CHERASSE Investigator, MD
Facility Name
Mutualist Clinic Porte de l'Orient (Lorient)
City
Lorient
ZIP/Postal Code
56100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre GRAZIANA Investigator, MD
Facility Name
Clinic Saint George (Nice)
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohann ROUSCOFF Investigator, MD
Facility Name
Saint Louis University Hospital Center (Paris)
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François MEYER Investigator, MD
Facility Name
Regional University Hospital Center (Strasbourg)
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian SAUSSINE Investigator, MD

12. IPD Sharing Statement

Learn more about this trial

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

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