NCT05687019

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostatic Adenoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Intravesical instillations of Ialuril® Prefill	5 injections of Ialuril® Prefill on D0 or D1, D7, D14, D21 and D28 after Holmium laser surgery for prostate adenoma

Timeline

• Start date: 2023-09-12
• Primary completion: 2025-06-24
• Completion: 2025-06-24
• First posted: 2023-01-17
• Last updated: 2025-07-25

Locations

1 site across 1 country: France