CompletedNot Applicable

Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma

France33 participantsStarted 2023-09-12

Plain-language summary

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.

Who can participate

Age range18 Years

SexMALE

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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.

What they're measuring

International Prostate Score Symptom on Day 28

Timeframe: 28 days

Trial details

NCT IDNCT05687019

SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-24

View on ClinicalTrials.gov More Prostatic Adenoma trials