Sclerotherapy of hydro and spermatoceles with 2ml Aetoxysclerol 30mg/ml vs. a combination of 2ml Aetoxysclerol 30mg/ml and 25ml of ethanol 99,5% with or without local anesthesia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502284-38-00

Enrollment

300

Registered

2024-11-06

Start date

2025-05-05

Completion date

Unknown

Last updated

2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spermatocele, Hydrocele

Brief summary

Symptoms from the treated side 3 months from treatment, Pain according to numeric rating scale (0-10) during treatement, Anti-coaculant therapy not suitable to suspend before treatment, Allergy to ethanol, Aethoxysclerol or ant local anaestethics used in the study, Mental disability, reluctance of the patient or language barriers making the purpose of participating in the study difficult to grasp, Current or just finished participation in another clinical pharmacological study, Prior participation in the study at hand, Treatment with immuno-stimulating drugs, Hydro or spermatocele not able to be evacuated percutaneously

Detailed description

Complications 30 days from treatement, Retreatement on the treated side, Symptoms from the treated side 24 months from treatment, Pain according to numeric rating scale (0-10) 1 day after treatment

Interventions

DRUGRopivacain Sintetica 7

DRUG5 mg/ml Injektionslösung

DRUGBupivacaine Baxter 5 mg/ml injektionsvätska

DRUGlösning

DRUGAethoxysklerol 30 mg/ml injektionsvätska

DRUGMepivacaine Accord 10 mg/ml injektionsvätska

DRUGLidocaine Accord 10 mg/ml injektionsvätska

DRUGETHANOL

DRUGANHYDROUS

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Symptoms from the treated side 3 months from treatment, Pain according to numeric rating scale (0-10) during treatement, Anti-coaculant therapy not suitable to suspend before treatment, Allergy to ethanol, Aethoxysclerol or ant local anaestethics used in the study, Mental disability, reluctance of the patient or language barriers making the purpose of participating in the study difficult to grasp, Current or just finished participation in another clinical pharmacological study, Prior participation in the study at hand, Treatment with immuno-stimulating drugs, Hydro or spermatocele not able to be evacuated percutaneously	—

Measure

Time frame

—

Secondary

Measure	Time frame
Complications 30 days from treatement, Retreatement on the treated side, Symptoms from the treated side 24 months from treatment, Pain according to numeric rating scale (0-10) 1 day after treatment	—

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026