Hemorrhagic CystitisNCT04696666
Tolerability and Efficacy of INSTYLAN in Subjects With Moderate to Severe Hemorrhagic Cystitis
A study testing INSTYLAN (Sodium Hyaluronate 80mg/50ml) in people with Hemorrhagic Cystitis, run by LIDDE Therapeutics at 10 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhagic Cystitis
- What is being tested?
- INSTYLAN (Sodium Hyaluronate 80mg/50ml)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 10 sitesFrance
- Study dates
- 15 May 2020to 30 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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,
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- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Aix en Provence Hospital Center
Aix-en-Provence, 13616
Marc FOURMARIER Principal Investigator, MD
- Recruiting
Ajaccio Hospital Center (Notre Dame de la Miséricorde)
Ajaccio, 20167
Sylvain DUCROCQ Investigator
- Recruiting
Polyclinic Sainte Marguerite (Auxerre)
Auxerre, 89000
Nordine DEFFAR Investigator, MD
- Recruiting
Clinic Rhône Durance (Avignon)
Avignon, 84000
Christophe CLEMENT Investigator, MD
- Recruiting
Cahors Hospital Center
Cahors, 46000
Youssef BENTALEB Investigator, MD
- Recruiting
Clinic of Val d'Ouest (Ecully)
Écully, 69130
Arnaud CHERASSE Investigator, MD
- Recruiting
Mutualist Clinic Porte de l'Orient (Lorient)
Lorient, 56100
Jean-Pierre GRAZIANA Investigator, MD
- Recruiting
Clinic Saint George (Nice)
Nice, 06000
Yohann ROUSCOFF Investigator, MD
- Recruiting
Saint Louis University Hospital Center (Paris)
Paris, 75010
François MEYER Investigator, MD
- Recruiting
Regional University Hospital Center (Strasbourg)
Strasbourg, 67091
Christian SAUSSINE Investigator, MD
About this study
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
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.
Read the 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
- Being tested
- INSTYLAN (Sodium Hyaluronate 80mg/50ml)
- Keywords
- Hemorrhagic cystitis
- Medical subject headings
- Cystitis, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks | Experimental | Single Group Assignment Receives: Device: INSTYLAN (Sodium Hyaluronate 80mg/50ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 10
Secondary outcomes (3)
Evaluation of hematuria following a rating scale
Verbal rating scale of the colour of the urines: yellow, pink or red-brownish
Measured: Baseline, week 7 and week 10
Evaluation of number of micturitions / 24 hours
Voiding diary sheet for each 24-hour period
Measured: Baseline, week 7 and week 10
Evaluation of urgency of micturitions following a rating scale
Verbal rating scale (slight, moderate, important)
Measured: Baseline, week 7 and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start15 May 2020
- Primary completion30 May 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic CystitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LIDDE Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc FOURMARIER, MD, Principal investigator, Aix en Provence Hospital Center (Aix en Provence)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696666
- Sponsor's protocol ID
- CLIN-INST01F
- Status last verified
- Jan 2021
- First submitted
- 3 Jan 2021
- Last updated
- 6 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04696666
- Acronym / sponsor ID
- CLIN-INST01F
- Conditions
- Hemorrhagic Cystitis
- Keywords
- Hemorrhagic cystitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LIDDE TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 30 May 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks | Experimental | Device: INSTYLAN (Sodium Hyaluronate 80mg/50ml)Single Group Assignment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients assigned in a single group and treated with 6 instillations of INSTYLAN for 6 weeks |
Primary outcome
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7
Time frame: 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
Time frame: Week 10
Questionnaire with 5 closed-ended response options: no pain, slight pain, moderate pain, severe pain, very severe pain
3 secondary outcomes
Evaluation of hematuria following a rating scale
Time frame: Baseline, week 7 and week 10
Evaluation of number of micturitions / 24 hours
Time frame: Baseline, week 7 and week 10
Evaluation of urgency of micturitions following a rating scale
Time frame: Baseline, week 7 and week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc FOURMARIER, MD principal investigator
Aix en Provence Hospital Center (Aix en Provence)
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSTYLAN (Sodium Hyaluronate 80mg/50ml) in people with Hemorrhagic Cystitis, run by LIDDE Therapeutics at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François SCHUTZE, PhD (+33 (0)6 83 54 01 42, fr.schutze@liddetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the intensity of bladder pain from the beginning of the study (baseline: Week 1) to Week 7 (time frame: Week 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021; AzTrials last refreshed its copy on 8 Nov 2026.