Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma (HOLEP-AHCS)

April 9, 2024 updated by: GCS Ramsay Santé pour l'Enseignement et la Recherche

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Quint-Fonsegrives, France, 31130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient undergoing prostate enucleation by Holmium Laser
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
International Prostate Score Symptom on Day 28
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 17, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A01882-41

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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