Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma
NCT ID: NCT05687019
Last Updated: 2025-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2023-09-12
2025-06-24
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Euraxi Pharma
INDUSTRY
GCS Ramsay Santé pour l'Enseignement et la Recherche
OTHER
Responsible Party
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Locations
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Clinique La Croix du Sud
Quint-Fonsegrives, , France
Countries
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Other Identifiers
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2022-A01882-41
Identifier Type: -
Identifier Source: org_study_id
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