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

Last updated: January 5, 2021
Sponsor: LIDDE Therapeutics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gynecological Infections

Urinary Tract Infections

Urinary Incontinence

Treatment

N/A

Clinical Study ID

NCT04696666
CLIN-INST01F
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and females, at least 18 years,
  • Patients who provided signed written informed consent, which includes compliance withrequirements listed in the consent form,
  • Patients with diagnosis of Hemorrhagic Cystitis,
  • Patients with diagnosis of bladder pain (pressure or pelvic discomfort) with at leastone other urinary symptom (need to urinate right away (urgency), often (frequency), orboth).

Exclusion

Exclusion Criteria:

  • Patients with Post-void residual (PVR) urine volume > 200ml,
  • Patients presently treated with intravesical treatment (replenishment therapy withglycosaminoglycans),
  • 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 ortreatment 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 theInvestigator, may either put the participants at risk because of participation in thetrial, or may influence the result of the trial, or the participant's ability toparticipate in the trial.

Study Design

Total Participants: 30
Study Start date:
May 15, 2020
Estimated Completion Date:
July 30, 2021

Study 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.

Connect with a study center

  • Aix en Provence Hospital Center

    Aix-en-Provence, 13616
    France

    Active - Recruiting

  • Ajaccio Hospital Center (Notre Dame de la Miséricorde)

    Ajaccio, 20167
    France

    Active - Recruiting

  • Polyclinic Sainte Marguerite (Auxerre)

    Auxerre, 89000
    France

    Active - Recruiting

  • Clinic Rhône Durance (Avignon)

    Avignon, 84000
    France

    Active - Recruiting

  • Cahors Hospital Center

    Cahors, 46000
    France

    Active - Recruiting

  • Clinic of Val d'Ouest (Ecully)

    Ecully, 69130
    France

    Active - Recruiting

  • Mutualist Clinic Porte de l'Orient (Lorient)

    Lorient, 56100
    France

    Active - Recruiting

  • Clinic Saint George (Nice)

    Nice, 06000
    France

    Active - Recruiting

  • Saint Louis University Hospital Center (Paris)

    Paris, 75010
    France

    Active - Recruiting

  • Regional University Hospital Center (Strasbourg)

    Strasbourg, 67091
    France

    Active - Recruiting

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