Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma (HOLEP-AHCS)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Completed

Conditions: Prostatic Adenoma

Treatments: Combination Product: Intravesical instillations of Ialuril® Prefill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05687019

2022-A01882-41

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 33 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Patient undergoing prostate enucleation by Holmium Laser

Experimental group

Description:

It is based on a pulsed laser at a wavelength of 2140 nm, which penetrates the tissues over a very short distance. The prostate tissue must therefore be in contact with the laser fiber to be cut or vaporized, and hemostasis will take place nearby. The procedure lasts approximately one hour.

Treatment:

Combination Product: Intravesical instillations of Ialuril® Prefill