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

Prostatic Adenoma Clinical Trial

— HOLEP-AHCS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05687019
• Other study ID #: 2022-A01882-41
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Christophe TOLLON, MD
• Phone: 561549696
• Email: tol[@]club-internet.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Prostatic Adenoma
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
France	Clinique La Croix du Sud	Quint-Fonsegrives

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	International Prostate Score Symptom on Day 28		28 days