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Completed

NCT Number: NCT05687019

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

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.

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Key information

Conditions

Prostatic Adenoma Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Clinique La Croix du Sud

Quint-Fonsegrives, 31130, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. International Prostate Score Symptom on Day 28

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • Euraxi Pharma

Registry information

Official study title

Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)

Acronym: HOLEP-AHCS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 17, 2023
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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