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

NCT04696666 | Unknown

• 1 other identifier: CLIN-INST01F
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 10

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.

Conditions

Hemorrhagic Cystitis

Keywords

Hemorrhagic cystitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Evaluation of hematuria following a rating scale

  Baseline, week 7 and week 10

• Evaluation of number of micturitions / 24 hours

  Baseline, week 7 and week 10

• Evaluation of urgency of micturitions following a rating scale

  Baseline, week 7 and week 10

Study Arms (1)

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

EXPERIMENTAL

Single Group Assignment

Device: INSTYLAN (Sodium Hyaluronate 80mg/50ml)

Interventions

INSTYLAN (Sodium Hyaluronate 80mg/50ml) 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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• LIDDE Therapeutics: lead

Study Sites (10)

Aix en Provence Hospital Center

Aix-en-Provence, 13616, France

RECRUITING

Ajaccio Hospital Center (Notre Dame de la Miséricorde)

Ajaccio, 20167, France

RECRUITING

Polyclinic Sainte Marguerite (Auxerre)

Auxerre, 89000, France

RECRUITING

Clinic Rhône Durance (Avignon)

Avignon, 84000, France

RECRUITING

Cahors Hospital Center

Cahors, 46000, France

RECRUITING

Clinic of Val d'Ouest (Ecully)

Écully, 69130, France

RECRUITING

Mutualist Clinic Porte de l'Orient (Lorient)

Lorient, 56100, France

RECRUITING

Clinic Saint George (Nice)

Nice, 06000, France

RECRUITING

Saint Louis University Hospital Center (Paris)

Paris, 75010, France

RECRUITING

Regional University Hospital Center (Strasbourg)

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Cystitis, Hemorrhagic

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Marc FOURMARIER, MD

  Aix en Provence Hospital Center (Aix en Provence)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François SCHUTZE, PhD

CONTACT

+33 (0)6 83 54 01 42; fr.schutze@liddetherapeutics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2021
• First Posted: January 6, 2021
• Study Start: May 15, 2020
• Primary Completion: May 30, 2021
• Study Completion: July 30, 2021
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

FR (10)