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

Last updated: March 24, 2025
Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Cancer

Prostate Disorders

Benign Prostatic Hyperplasia (Enlarged Prostate)

Treatment

Intravesical instillations of Ialuril® Prefill

Clinical Study ID

NCT05687019
2022-A01882-41
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient eligible for a HOLEP procedure, according to the investigator ;

  • Patient able to understand the information related to the clinical investigation, toread the information leaflet and agrees to sign the consent form.

Exclusion

Exclusion Criteria:

  • Known intolerance to one of the treatment components: hyaluronic acid, chondroitinsulphate, 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 ofliberty;

  • Participating patient, or in a period of exclusion from another clinical trial;

  • Patient not benefiting from a social security scheme.

Study Design

Total Participants: 34
Treatment Group(s): 1
Primary Treatment: Intravesical instillations of Ialuril® Prefill
Phase:
Study Start date:
September 12, 2023
Estimated Completion Date:
August 31, 2025

Study 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.

Connect with a study center

  • Clinique La Croix du Sud

    Quint-Fonsegrives, 31130
    France

    Active - Recruiting

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