Prostatic AdenomaHOLEP-AHCSNCT05687019
Efficacy of Hyaluronic Acid Injections on Functional Recovery After Surgery for Prostate Adenoma
A study testing Intravesical instillations of Ialuril® Prefill in people with Prostatic Adenoma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Adenoma
- What is being tested?
- Intravesical instillations of Ialuril® Prefill
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 12 Sep 2023to 24 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostatic Adenoma
- Being tested
- Intravesical instillations of Ialuril® Prefill
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical instillations of Ialuril® PrefillCombination product
5 injections of Ialuril® Prefill on D0 or D1, D7, D14, D21 and D28 after Holmium laser surgery for prostate adenoma
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing prostate enucleation by Holmium Laser | Experimental | 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. Receives: Combination Product: Intravesical instillations of Ialuril® Prefill |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Prostate Score Symptom on Day 28
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start12 Sep 2023
- Primary completion24 Jun 2025
- Study completion24 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic AdenomaStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Euraxi Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687019
- Sponsor's protocol ID
- 2022-A01882-41
- Acronym
- HOLEP-AHCS
- Status last verified
- Jul 2025
- First submitted
- 6 Jan 2023
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hyaluronic Acid and Chondroitin Sulphate in Intravesical Injections on Functional Recovery After Holmium Laser Surgery for Prostate Adenoma (HOLEP-AHCS)
- ClinicalTrials.gov ID
- NCT05687019
- Acronym / sponsor ID
- HOLEP-AHCS / 2022-A01882-41
- Conditions
- Prostatic Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Euraxi Pharma
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 24 Jun 2025 (actual)
- Study completion
- 24 Jun 2025 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing prostate enucleation by Holmium Laser | Experimental | Combination Product: Intravesical instillations of Ialuril® PrefillIt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical instillations of Ialuril® Prefill5 injections of Ialuril® Prefill on D0 or D1, D7, D14, D21 and D28 after Holmium laser surgery for prostate adenoma | Combination product | Patient undergoing prostate enucleation by Holmium Laser |
Primary outcome
International Prostate Score Symptom on Day 28
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravesical instillations of Ialuril® Prefill in people with Prostatic Adenoma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Score Symptom on Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.