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Trial Title:
Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma
NCT ID:
NCT05687019
Condition:
Prostatic Adenoma
Conditions: Official terms:
Adenoma
Prostatic Hyperplasia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Intravesical instillations of Ialuril® Prefill
Description:
5 injections of Ialuril® Prefill on D0 or D1, D7, D14, D21 and D28 after Holmium laser
surgery for prostate adenoma
Arm group label:
Patient undergoing prostate enucleation by Holmium Laser
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinique La Croix du Sud
Address:
City:
Quint-Fonsegrives
Zip:
31130
Country:
France
Status:
Recruiting
Contact:
Last name:
Christophe TOLLON, MD
Email:
tol@club-internet.fr
Start date:
September 12, 2023
Completion date:
August 31, 2025
Lead sponsor:
Agency:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Agency class:
Other
Source:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05687019
