Ongoing Clinical Trials for Spermatocele
Currently, there is 1 ongoing clinical trial investigating treatment options for spermatocele, a fluid-filled sac that develops in the epididymis near the testicle. This trial is exploring sclerotherapy as a minimally invasive 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 both spermatocele and hydrocele, conditions where fluid accumulates in the scrotum causing swelling. The study is being conducted in Sweden and aims to compare different treatment approaches to find the most effective method for managing these conditions.
Main focus and goal: The trial is comparing the effectiveness of using Aetoxysclerol (lauromacrogol 400) alone versus combining it with ethanol. Researchers want to understand which approach better reduces symptoms and decreases the need for additional treatment. The study will monitor patients for up to 24 months, with specific assessments at 3 months and 24 months after treatment. The trial also examines different pain management strategies, including whether local anesthesia is necessary during the procedure.
Investigational drugs: The main medication being tested is Aetoxysclerol, a sclerosing agent that works by irritating the lining of blood vessels, causing them to collapse and eventually be absorbed by the body. In some treatment groups, Aetoxysclerol is combined with ethanol (a type of alcohol) to potentially enhance the shrinking effect on the fluid-filled sacs. The trial also uses various local anesthetics including mepivacaine, ropivacaine, lidocaine, and bupivacaine to manage pain during the procedure.
Who can participate – inclusion criteria:
- Men aged 30 years or older
- Diagnosed with a spermatocele or hydrocele of at least 50ml in size (measured by orchidometry)
- Experiencing noticeable inconvenience from the condition, though it does not prevent daily activities
- Able to provide informed consent and understand the study procedures
Who cannot participate – exclusion criteria:
- Individuals who belong to vulnerable populations requiring special protection or care
- Those outside the specified adult age range
- Women are excluded from this study as it focuses on male-specific conditions
What happens during the trial: After joining the study and providing consent, participants will undergo sclerotherapy, which involves injecting the treatment medication directly into the affected area. Depending on the treatment group assigned, patients will receive either 4ml of Aetoxysclerol alone or combined with 50ml of ethanol. Pain management options include no anesthesia, a spermatic cord block, or instillation anesthesia. Pain levels are assessed using a scale from 0 to 10 during the procedure and one day after treatment. Participants are monitored for complications within 30 days and attend follow-up assessments to evaluate symptoms and determine if retreatment is needed.
Summary
Currently, only one clinical trial is actively recruiting patients with spermatocele, located in Sweden. This trial takes a comprehensive approach by studying both spermatocele and hydrocele together, as they are related conditions involving fluid accumulation in the scrotum. The focus on sclerotherapy represents a minimally invasive alternative to surgical treatment, which may offer benefits in terms of recovery time and reduced complications.
The trial’s design is notable for comparing two different treatment approaches: using Aetoxysclerol alone versus combining it with ethanol. This comparison will help determine whether the combination therapy offers additional benefits over single-agent treatment. The study also addresses practical concerns about pain management, exploring whether local anesthesia is necessary during the procedure.
With a long follow-up period of up to 24 months, this trial aims to provide meaningful data on the durability of treatment results and the likelihood of symptom recurrence. For men aged 30 and older experiencing noticeable discomfort from spermatocele or hydrocele, this trial offers an opportunity to access an alternative treatment approach while contributing to medical knowledge about managing these common conditions.
