Hyaluronic acid injections for recovery after prostate surgery
Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)
This study is testing if hyaluronic acid injections can help improve urinary function in men recovering from prostate surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Quint-Fonsegrives) |
| Trial ID | NCT05687019 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Ialuril® Prefill, a hyaluronic acid treatment, in improving urinary function in patients who have undergone surgery for prostatic adenoma. It is a non-comparative, open-label, monocentric interventional study that measures changes in the International Prostate Score Symptom over a 28-day period. Patients eligible for the HOLEP procedure will receive intravesical instillations of the treatment, and their urinary function will be assessed before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are patients scheduled for a HOLEP procedure who can understand and consent to the study.
Not a fit: Patients with known intolerance to the treatment components or those with a prostatic volume greater than 140 cm3 may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance urinary function recovery for patients after prostate surgery.
How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in using hyaluronic acid for functional recovery in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Quint-Fonsegrives
- Clinique La Croix du Sud — Quint-Fonsegrives, France (Recruiting)
Study contacts
- Study coordinator: Christophe TOLLON, MD
- Email: tol@club-internet.fr
- Phone: 561549696
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.