Study on Sclerotherapy for Hydrocele and Spermatocele Using Lauromacrogol 400 and Ethanol in Adult Patients

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What is this study about?

This clinical trial is focused on studying the treatment of two conditions: hydrocele and spermatocele. These are conditions where fluid accumulates in the scrotum, causing swelling. The study will use a treatment called Aetoxysclerol, which is a solution for injection, and it will be compared with a combination of Aetoxysclerol and ethanol, a type of alcohol. The purpose of the study is to compare the effectiveness of these treatments in reducing symptoms and the need for additional treatment.

Participants in the study will receive either Aetoxysclerol alone or in combination with ethanol. The study will also look at the level of pain experienced during treatment, with or without the use of local anesthesia, which is a type of medication used to numb a specific area of the body. The study will monitor symptoms and any need for retreatment over a period of three months after the initial treatment.

The trial will also assess any complications that may arise within 30 days of treatment and will continue to observe symptoms for up to 24 months. The study aims to provide valuable information on the best treatment approach for managing hydrocele and spermatocele, helping to improve patient care and outcomes in the future.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. Consent is required to participate.

Eligibility is based on having a hydrocele or spermatocele of at least 50ml, being 30 years or older, and experiencing symptoms that are noticeable but do not interfere with daily activities.

2 treatment preparation

The patient will be prepared for the treatment, which involves sclerotherapy. This is a procedure used to treat hydroceles and spermatoceles.

The treatment options include using 4ml of Aetoxysclerol 30mg/ml alone or in combination with 50ml of ethanol 99.5%.

3 anesthesia options

The patient may receive local anesthesia to minimize discomfort during the procedure. Options include no anesthesia, a spermatic cord block, or instillation anesthesia.

4 treatment administration

The treatment will be administered through local injection or infiltration, depending on the specific medication used.

The medications involved in the trial include ethanol, anhydrous, mepivacaine hydrochloride, ropivacaine hydrochloride, lidocaine hydrochloride, lauromacrogol 400, and bupivacaine hydrochloride.

5 post-treatment observation

After the treatment, the patient will be monitored for any immediate reactions or complications.

Pain levels will be assessed using a numeric rating scale from 0 to 10 during and one day after the treatment.

6 follow-up assessments

The patient will have follow-up assessments to evaluate symptoms and any need for retreatment. These assessments will occur 3 months and 24 months after the treatment.

Complications will be monitored for 30 days following the treatment.

Who Can Join the Study?

The patient must have a hydrocele or spermatocele. These are conditions where fluid builds up in the scrotum.
The patient must provide informed consent, which means they understand the study and agree to participate.
The patient must experience inconvenience from their condition that is noticeable but does not stop them from doing daily activities.
The patient must be 30 years old or older.
The hydrocele or spermatocele must be at least 50ml in size, which is measured using a method called orchidometry.

Who Cannot Join the Study?

Individuals with a condition called Spermatocele cannot participate. A spermatocele is a fluid-filled sac that grows in the epididymis, a small tube located near the testicles.
Individuals with a condition called Hydrocele cannot participate. A hydrocele is a swelling in the scrotum that occurs when fluid collects in the thin sheath surrounding a testicle.
Only male participants are allowed in the study.
Participants must be within certain age ranges, specifically adults.
Individuals who are considered part of a vulnerable population are not eligible. This means people who might need special protection or care, like those with certain disabilities or conditions.

Where you can join this trial?

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Site Name	City	Country
Region Jaemtland Haerjedalen	Ostersund	Sweden
Region Vaesternorrland	Sundsvall	Sweden
Cypjrzywm Bnjcoeip	Falun	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Recruiting	16.09.2024

Trial locations

Investigated drugs:

Aetoxysclerol is a medication used in this trial to treat hydroceles and spermatoceles. It is administered as an injection to help reduce the size of these fluid-filled sacs by causing them to shrink. The trial is comparing the effects of using Aetoxysclerol alone versus in combination with another substance.

Ethanol is used in combination with Aetoxysclerol in this trial. Ethanol is a type of alcohol that, when injected, can help enhance the shrinking effect on hydroceles and spermatoceles. The trial is investigating whether this combination is more effective than using Aetoxysclerol alone.

Local Anesthesia is used in some cases during the treatment to help manage pain. It involves numbing the area where the procedure is performed, which can make the treatment more comfortable for the patient. The trial is exploring different methods of anesthesia to determine the best approach for pain management during the procedure.

Investigated diseases:

Spermatocele – A spermatocele is a fluid-filled sac that develops in the epididymis, which is a small coiled tube located in the upper testicle. It is typically painless and may feel like a smooth, firm lump in the scrotum. The size of a spermatocele can vary, and it may grow larger over time. Although it is usually benign, it can cause discomfort or a feeling of heaviness in the scrotum if it becomes large. Spermatoceles are often discovered during a routine physical examination or self-examination. They do not affect fertility and are generally not associated with any serious health issues.

Hydrocele – A hydrocele is a condition characterized by the accumulation of fluid in the sac surrounding a testicle, leading to swelling in the scrotum. It is common in newborns and usually resolves on its own within the first year of life, but it can also occur in older males due to injury or inflammation. Hydroceles are generally painless, but the swelling can cause discomfort or a feeling of heaviness. The size of the hydrocele can fluctuate, often increasing during the day and decreasing at night. While hydroceles are not harmful, they can sometimes indicate an underlying issue, such as infection or a tumor. They are typically diagnosed through physical examination and may require further evaluation if symptoms persist.

Trial ID:

2022-502284-38-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Sclerotherapy for Hydrocele and Spermatocele Using Lauromacrogol 400 and Ethanol in Adult Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?