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

GCS Ramsay Santé pour l'Enseignement et la Recherche33 enrolled

Overview

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.

This is an interventional, non-comparative, open-label, monocentric study aimed at evaluating treatment with hyaluronic acid in patients who have undergone surgery (HOLEP procedure) for prostatic adenoma.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Adenoma

Interventions

Intravesical instillations of Ialuril® PrefillCOMBINATION_PRODUCT

5 injections of Ialuril® Prefill on D0 or D1, D7, D14, D21 and D28 after Holmium laser surgery for prostate adenoma

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Clinique La Croix du Sud

Quint-Fonsegrives, France

Outcomes

Primary Outcomes

International Prostate Score Symptom on Day 28

Time frame: 28 days

Data from ClinicalTrials.gov

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