NCT04696666

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: LIDDE Therapeutics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2020-05-15
• Primary completion: 2021-05-30
• Completion: 2021-07-30
• First posted: 2021-01-06
• Last updated: 2021-01-06

Locations

10 sites across 1 country: France