Prostatic Adenoma
Conditions
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.
Interventions
COMBINATION_PRODUCTIntravesical 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
Sponsors
Euraxi Pharma
GCS Ramsay Santé pour l'Enseignement et la Recherche
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| International Prostate Score Symptom on Day 28 | 28 days |
Countries
France
Outcome results
None listed