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

Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05687019
Collaborator
(none)
34
Enrollment
1
Arm
13.5
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Intravesical instillations of Ialuril® Prefill
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Feb 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. International Prostate Score Symptom on Day 28 [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GCS Ramsay Santé pour l'Enseignement et la Recherche
ClinicalTrials.gov Identifier:
NCT05687019
Other Study ID Numbers:
  • 2022-A01882-41
First Posted:
Jan 17, 2023
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Adenoma
Prostatic Hyperplasia

Study Results

No Results Posted as of Jan 17, 2023