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

NCT ID: NCT04696666

Last Updated: 2021-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2021-07-30

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.

Conditions

Hemorrhagic Cystitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Single Group Assignment

Group Type: EXPERIMENTAL

INSTYLAN (Sodium Hyaluronate 80mg/50ml)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LIDDE Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc FOURMARIER, MD

Role: PRINCIPAL_INVESTIGATOR

Aix en Provence Hospital Center (Aix en Provence)

Locations

Aix en Provence Hospital Center

Aix-en-Provence, , France

Site Status: RECRUITING

Ajaccio Hospital Center (Notre Dame de la Miséricorde)

Ajaccio, , France

Site Status: RECRUITING

Polyclinic Sainte Marguerite (Auxerre)

Auxerre, , France

Site Status: RECRUITING

Clinic Rhône Durance (Avignon)

Avignon, , France

Site Status: RECRUITING

Cahors Hospital Center

Cahors, , France

Site Status: RECRUITING

Clinic of Val d'Ouest (Ecully)

Écully, , France

Site Status: RECRUITING

Mutualist Clinic Porte de l'Orient (Lorient)

Lorient, , France

Site Status: RECRUITING

Clinic Saint George (Nice)

Nice, , France

Site Status: RECRUITING

Saint Louis University Hospital Center (Paris)

Paris, , France

Site Status: RECRUITING

Regional University Hospital Center (Strasbourg)

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

François SCHUTZE, PhD

Role: CONTACT

fr.schutze@liddetherapeutics.com

+33 (0)6 83 54 01 42

Facility Contacts

Marc FOURMARIER Principal Investigator, MD

Role: primary

Sylvain DUCROCQ Investigator

Role: primary

Nordine DEFFAR Investigator, MD

Role: primary

Christophe CLEMENT Investigator, MD

Role: primary

Youssef BENTALEB Investigator, MD

Role: primary

Arnaud CHERASSE Investigator, MD

Role: primary

Jean-Pierre GRAZIANA Investigator, MD

Role: primary

Yohann ROUSCOFF Investigator, MD

Role: primary

François MEYER Investigator, MD

Role: primary

Christian SAUSSINE Investigator, MD

Role: primary

Other Identifiers

CLIN-INST01F

Identifier Type: -

Identifier Source: org_study_id