A Randomized Trial Comparing Two doses of Polidocancol for Sclerotherapy of Hydrocele and Spermatocele

 

Background
Polidocanol sclerotherapy for hydrocele and spermatocele combines high efficiency with low morbidity and has become more popular the last decades. The optimal dose is not known.  We compared efficacy and morbidity of 2 ml or 4 ml Polidocanol sclerotherapy for hydrocele or spermatocele.

Materials and Methods
In 1993-2005 a double-blind randomized trial was conducted using 2 or 4 ml of polidocanol (30mg/ml) for sclerotherapy of hydrocele/spermatocele in 224 evaluable patients, age above 35 years, at three University Hospitals. Under local anesthetics fluid was evacuated by a canula and followed by immeadiate injection of 2-4 ml of polidocanol. This injection was made by a nurse, with the amount injected concealed from the treating physician and the patient.  At three month follow-up morbidity was as certain edusing a questionnaire completed by the patients and case records were reviewed to see if there had been any complications. Fluid recurrence was determined clinically and generally re-treated.

Definitions: Spermatocele–Opalescent fluid, grey. Containing spermatozoids;  Hydrocele- Yellowish liquid spermatozoid-free;  Cure- No liquid or  <10 ml and <10% of initial liquid;  Small amount of residual liquid- <40ml and <10% of initial liquid; Unsatisfactory- Patients submitted to surgery, left with more than a small amount of liquid, or lost to follow-up;  Epididymitis- swollen and tender epididymis diagnosed on scheduled follow-up or emergency visit;  Intensity of complications:
Low- Pain or discomfort without need for medication; Moderate- Pain or fever requiring for self-medication or telephone discussion with Urologist.
High- Pain leading to emergency contact and treatment with antibiotics and/or NSAIDs.

Results:
224 patients 67% Hydrocele, 33% Spermatocele. Cure after first treatment 120 ( 54%).
210 (94%) had satisfactory results after 1-4 treatments.  Complications in  55 patients and 89% of the complications were low to moderate in intensity.  Epididymitis was treated with antibiotics in 3 weeks which generally led to resolution of symptoms.
Cure after first treatment was more common in the 4 ml group (chi square 4,4 p=0,04). Complications occurred more often in the 4 ml group (chi square 4,1, p=0,04) All patients with high-intensity complications had received 4 ml.  Patients with larger amounts of fluid (<175ml) experienced more success treated with 4 ml than 2 ml. 58%  vs 37% cure rate after first round. (chi square 6,3, p=0,01). No difference in primary cure was observed with respect to age, side, type or amount of fluid where as patients with time to onset >24 months where more prone to recurrence than those with shorter time to onset.  More complications were detected in the 4 ml group but this difference was not significant in multivariate analysis.

Logistic regression analyses of variables of importance for recurrence or for having any complication after the first polidocanol sclerotherapy for hydrocele or spermatocele. Recurrence or complications after the first treatment were the dependent variables.

Conclusion
Our findings suggest that sclerotherapy should be considered for treatment of hydrocele and spermatocele. Larger fluid amounts are probably best treated with 4 ml Polidocanol compared to 2 ml.