In short
Currently, there is 1 clinical trial underway investigating treatment options for hydrocele, a condition where fluid accumulates in the scrotum causing swelling. This trial is exploring sclerotherapy as an alternative treatment approach and is being conducted in Sweden.
Clinical trial locations
Study on Sclerotherapy for Hydrocele and Spermatocele Using Lauromacrogol 400 and Ethanol in Adult Patients
This clinical trial is investigating sclerotherapy as a treatment option for hydrocele and spermatocele, conditions where fluid builds up in the scrotum causing swelling. The study is comparing two different treatment approaches to see which works better at reducing symptoms and the need for additional treatment.
Main inclusion criteria:
- Patients must have a diagnosed hydrocele or spermatocele of at least 50ml in size
- Participants must be 30 years of age or older
- The condition must cause noticeable inconvenience, though not severe enough to prevent daily activities
- Informed consent to participate in the study is required
Main exclusion criteria:
- Only male participants can join the study
- Individuals considered part of a vulnerable population requiring special protection are not eligible
- Participants must meet specific age requirements
Focus and goals:
The trial aims to determine the most effective treatment approach for managing hydrocele and spermatocele. Participants will receive either Aetoxysclerol alone or in combination with ethanol. Aetoxysclerol is a sclerosing agent that, when injected into the affected area, causes the fluid-filled sacs to shrink. Ethanol is added in the combination treatment to potentially enhance this shrinking effect.
The study also examines pain management during the procedure, testing different approaches including no anesthesia, spermatic cord block, or instillation anesthesia. Pain levels will be measured using a scale from 0 to 10 during the treatment and one day afterward.
Patients will be monitored for immediate complications within 30 days of treatment and will have follow-up assessments at 3 months and 24 months to evaluate symptoms and determine if retreatment is necessary.
Investigational drugs:
The main treatment being tested is Aetoxysclerol, a medication administered by injection that works by irritating the lining of blood vessels, causing them to collapse and be absorbed by the body. This sclerosing agent is being used alone or in combination with ethanol, a type of alcohol that may enhance the therapeutic effect.
Several local anesthetics are also being studied for pain management during the procedure, including mepivacaine hydrochloride, ropivacaine hydrochloride, lidocaine hydrochloride, and bupivacaine hydrochloride. These medications numb the treatment area to make the procedure more comfortable for patients.
Summary
Currently, only one clinical trial is actively investigating new treatment approaches for hydrocele. This trial is being conducted in Sweden and focuses on sclerotherapy as a potentially less invasive alternative to traditional surgical treatment. The study is particularly notable for its comprehensive approach, examining not only treatment effectiveness but also pain management strategies during the procedure. By comparing Aetoxysclerol alone versus in combination with ethanol, and testing different anesthesia methods, this trial aims to provide valuable insights into optimizing patient care and outcomes for those living with hydrocele or spermatocele. The long follow-up period of up to 24 months will help researchers understand the lasting effects of these treatments.
