Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)

2022-A01882-41

The purpose of this study is to evaluate the score on urinary function (International Prostate Score Symptom) at 28 days. The main objective is to assess the efficacy of treatment with Ialuril® Prefill on functional recovery at 4 weeks, based on the International Prostate Score Symptom. A paired test will be performed to compare the International Prostate Score Symptom score between 0 and 28 days.

2023-09-12

2024-12-31

2024-12-31

Recruiting

34

Inclusion Criteria: * Patient eligible for a HOLEP procedure, according to the investigator ; * Patient able to understand the information related to the clinical investigation, to read the information leaflet and agrees to sign the consent form. Exclusion Criteria: * Known intolerance to one of the treatment components: hyaluronic acid, chondroitin sulphate, calcium chloride; * Prostatic volume greater than 140 cm3; * Patient under anticoagulant treatment for secondary prevention; * Patient under guardianship or curatorship, or under a regime of deprivation of liberty; * Participating patient, or in a period of exclusion from another clinical trial; * Patient not benefiting from a social security scheme.

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 34, 'type': 'ESTIMATED'}}

2024-04-10