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

NCT05687019 | Completed

• 1 other identifier: 2022-A01882-41
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Adenoma

Outcome Measures

Primary Outcomes (1)

• International Prostate Score Symptom on Day 28

  28 days

Study Arms (1)

Patient undergoing prostate enucleation by Holmium Laser

EXPERIMENTAL

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.

Combination Product: Intravesical instillations of Ialuril® Prefill

Interventions

Intravesical instillations of Ialuril® Prefill COMBINATION_PRODUCT

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

Patient undergoing prostate enucleation by Holmium Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patient not benefiting from a social security scheme.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead
• Euraxi Pharma: collaborator

Study Sites (1)

Clinique La Croix du Sud

Quint-Fonsegrives, 31130, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 17, 2023
• Study Start: September 12, 2023
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)