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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05687019
Other study ID # 2022-A01882-41
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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