Back to resultsEfficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma (HOLEP-AHCS)
Primary Purpose
Prostatic Adenoma
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intravesical instillations of Ialuril® Prefill
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Adenoma
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.
Sites / Locations
- Clinique La Croix du SudRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient undergoing prostate enucleation by Holmium Laser
Arm Description
It is based on a pulsed laser at a wavelength of 2140 nm, which penetrates the tissues over a very short distance. The prostate tissue must therefore be in contact with the laser fiber to be cut or vaporized, and hemostasis will take place nearby. The procedure lasts approximately one hour.
Outcomes
Primary Outcome Measures
International Prostate Score Symptom on Day 28
Secondary Outcome Measures
Full Information
NCT ID
NCT05687019
First Posted
January 6, 2023
Last Updated
October 9, 2023
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
1. Study Identification
Unique Protocol Identification Number
NCT05687019
Brief Title
Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
February 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Adenoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient undergoing prostate enucleation by Holmium Laser
Arm Type
Experimental
Arm Description
It is based on a pulsed laser at a wavelength of 2140 nm, which penetrates the tissues over a very short distance. The prostate tissue must therefore be in contact with the laser fiber to be cut or vaporized, and hemostasis will take place nearby. The procedure lasts approximately one hour.
Intervention Type
Combination Product
Intervention Name(s)
Intravesical instillations of Ialuril® Prefill
Intervention Description
5 injections of Ialuril® Prefill on D0 or D1, D7, D14, D21 and D28 after Holmium laser surgery for prostate adenoma
Primary Outcome Measure Information:
Title
International Prostate Score Symptom on Day 28
Time Frame
28 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe TOLLON, MD
Phone
561549696
Ext
+33
Email
tol@club-internet.fr
Facility Information:
Facility Name
Clinique La Croix du Sud
City
Quint-Fonsegrives
ZIP/Postal Code
31130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe TOLLON, MD
Email
tol@club-internet.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma
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