Is aspiration and sclerotherapy treatment for hydroceles in the aging male an evidence-based treatment?

Abstract

Symptomatic hydroceles are commonly treated with surgical repair. They are associated with sexual dysfunction in the aging male. Patients who are not fit for surgery often undergo aspiration and sclerotherapy of the hydrocele. There is a range of sclerosing agents used in the literature. I performed a literature search to assess whether one sclerosant was better than the others. STDS is the sclerosing agent with the best cure rate after a single injection and low side effect rates. The cure rates of sodium tetradecyl sulphate (STDS) after a single aspiration and injection were 76%. After multiple treatments 94% achieved a cure. Patient satisfaction rates at mean 40 months were 95%. Complication rates were generally low and much lower than surgical repair. Aspiration and sclerotherapy have a role in treating symptomatic hydroceles. This literature review shows that this is over and above its current use in the UK, where it is used for patients unfit for general anaesthetic. If the patients are carefully selected for this procedure, they can have a good outcome and avoid the higher complication rate and longer recovery rates of surgical repair. Patients should be counselled about aspiration and sclerotherapy as part of the informed consent process.

Keywords:

• Hydrocele
• sclerotherapy
• scrotal surgery
• consent

Introduction

Hydroceles can cause symptoms at any age. In an aging male, they can often cause sexual dysfunction as well [1]. Erectile dysfunction is also more prevalent in this group of men [2] and therefore it is important to treat the condition to improve their overall sexual health. Yu et al. [3] found that treatment of co-morbidities was essential to achieve good reproductive health. Treatment of symptomatic hydrocele is part of this. Large hydroceles also cause lower urinary tract symptoms. LUTS has higher prevalence in the aging population. Demir et al. found that patients with erectile dysfunction also had a high prevalence of severe LUTS [4]. There are correlations between the International Prostate Symptoms score questionnaire and the International Index of Erectile Function-5 questionnaire [5]. These are therefore essential co-morbidities to consider when assessing a gentleman with a hydrocele, which is causing sexual dysfunction.

The majority of hydroceles are treated with conservative treatment. The patient has an ultrasound scan to reassure them and the clinician that the underlying testicle is normal. If the hydrocele is particularly large or symptomatic then the patient can consider treatment. In the UK, the majority of hydroceles that require treatment are treated with surgery. Two main surgical techniques are used. The Lords plication, described in 1964 [6] and the Jaboulay repair in 1902 [7]. Aspiration and sclerotherapy are only usually considered in UK practice if the patient is not fit for surgical repair or unwilling to undergo scrotal surgery.

Porritt [8] first described aspirating hydroceles and injecting sclerosants. His sclerotherapy practice extended to treating varicoceles, bursae, and nevi. He had reasonable success with around 20 patients, he had one complete failure and two patients developed loculations and required further aspirations. Porritt describes many different fluids that had been tried prior to the development of sclerosants including the injection of port wine into the hydrocele sac. He however preferred sodium morrhuate as his sclerosing agent.

Some surgeons continued to perform aspiration and sclerotherapy with mixed success. Each surgeon had different sclerosant formulas. This led the British Medical Journal to ask the question in 1973 as to which the best sclerosant was. There were some sceptical physicians and surgeons who replied stating that nothing should be injected into a hydrocele as this causes painful side effects. Moloney [9] responded to a question saying that he had good results and he was an advocate for aspiration and sclerotherapy. He went on to publish his series [10]. He stated that he had been carrying out the procedure for around 20 years. He used phenol as his sclerosing agent. He thought that one of the most important parts of the procedure was that it was essential to insert the needle of cannula in the upper part of the hydrocele. Therefore, the sclerosant would not drain out of the tunica and would sclerose the correct layers and reduce the rate of recurrence. He thought that the reason that others did not have the same success rates as him was predominantly due to this subtle difference in technique.

Forty four years later on from this question posed in the BMJ, there still remains a question as to whether one sclerosant has better outcomes or a stronger evidence base than others. Does one have less side effects and a better chance of cure than others and how does aspiration and sclerotherapy compare to surgical repair? I therefore decided to carry out this literature review to assess whether I could find the best evidence based sclerosant.

Methods

I performed a literature search on both the Medline and Embase databases. I then reviewed each of the relevant papers and also went through their references to find papers that were not identified on my search. I used the keywords aspiration, sclerotherapy, sclerosant, hydrocele, phenol, alcohol, tetracycline, polidocanol, and sodium tetradecyl sulphate (STDS).

Results

The Medline search identified 107 papers when the keywords hydrocele and sclerotherapy were combined. I combined a search of hydrocele with the combination of phenol, polidocanol, STDS, tetracycline, and alcohol, which yielded 59 more papers. I then reviewed all of these papers and also went through their references to select the relevant studies. I have listed the results under the heading for each of the sclerosants below.

Phenol

Phenol was first described as a sclerosing agent in 1934 [11]. Carabba had been using phenol since 1929 for treating bursitis. Its first documented use for sclerotherapy for hydroceles was by Moloney in 1973 [9,10]. He used a solution of 2.5% phenol, 25% glucose and 25% glycerine which was previously used for sclerotherapy for varicose veins. For small hydroceles, he aspirated to dryness and injected 5 ml of fluid then up to 20 ml for hydroceles of 400–600 ml. He had good results 12 of 14 (85.7%) cure rate. The largest hydrocele treated was 700 ml. He had no complications in this series but has had two scrotal haematomas in the past 20 years in around 100 cases. It is not clear in this study how many treatments that he gave each patient. He stated that a hydrocele less than 400 ml should be cured in between one and three treatments. Larger hydroceles can require more treatments.

In response to the success of Moloney, Thompson and Odell published their series [12]. They treated 20 hydroceles with phenol using the same formula as Moloney, or alternatively with STDS. Their cure rates were 50%, which was the same for both sclerosant groups. It is noted however that Moloney states that for hydroceles over 400 ml, surgery is preferable. In the Thompson study, the average size of hydrocele was 450. This may well be the reason that they had poor results in comparison to Moloney.

A series by Nash [13] provided good results with phenol. He used a 2.5% solution with water for injection. He injected 5 ml for a hydrocele up to 50 ml, 10 ml for hydrocele 51–200 ml, 15 ml for hydrocele 201–400 and 20 ml for hydrocele over 400 ml. He treated 49 hydroceles with a recurrence rate at 1 year of 4%. Recurrence rate at 5 years was 12.2%. In this series, size did not appear to be a factor as the recurrences were spread evenly across the groups.

Savion et al. [14] treated 63 patients in their series. They used 2.5% phenol solution. They cured 51.6% with just one treatment, the other group required up to seven treatments and only one patient could not be cured with sclerotherapy.

Ozdemir [15] reviewed the literature and was concerned that often patients require repeated aspirations and injections. Three percent aqueous solution was used safely for the treatment of oesophageal varices and he therefore decided to use this to assess whether he could improve the results and decrease the recurrence and retreatment rates. He used 3% phenol in distilled water. He injected 1 ml of solution for every 10 ml of hydrocele fluid aspirated, up to a maximum injection of 20 ml. He treated 31 hydroceles. Five (16%) needed a single treatment, 17 (54%) required two treatments. The others took up to seven treatments and one required surgery after seven failed attempts. No patients experienced significant pain and only one patient developed a scrotal haematoma. The mean aspirated volume of fluid was only 148 ms. This is significantly less than the previous studies I have mentioned. The study showed no improvement with this concentration of phenol than the studies with 2.5%.

Shan et al. [16] compared sclerotherapy with surgery. Forty patients were in the sclerotherapy group. He used 2.5% aqueous phenol and injected 10% of the volume of fluid drained when he hydrocele was under 400 ml. When greater than this he used 5% of the fluid drained up to a maximum of 50 ml. This is significantly more than other studies that had maximums of 20 ml. His results showed a 97.5% overall cure rate. 47.5% cured at first injection and a further 30% after their second treatment. None of his patients experienced any pain or infection. There was no correlation to recurrence and the size of the initial hydrocele.

Phenol was used widely and then became the benchmark, which other treatments needed to improve on. Complication rates were very low, pain was generally very well controlled and not a concern when compared to other chemicals [17]. A prospective randomised study between phenol, polidocanol and surgery found that phenol was a much better sclerosant than polidocanol [18]. Their series contained 29 patients in each sclerosant group. Phenol had a 96.5% cure rate compared to polidocanol, which had just 51.7%. Pain however was more severe in the phenol group at one month but was similar at 4 months when recorded on a visual analogue scale.

Polidocanol

Polidocanol is used as a sclerosant for varicose veins. Lund et al. [19] performed a double blind, randomised controlled trial comparing polidocanol to placebo. Polidocanol was injected, 1 ml for hydrocele less than 100 ml, 2 ml for hydrocele 200–400 ml, 4 ml for hydrocele greater than 400 ml. This was then massaged into the scrotum. Recurrence was seen in 44% of patients compared to 78% in just the aspiration alone group. This result was statistically significant. Cure rates after multiple aspirations and injections were 89%. There were no significant complications. It is worth noting that in this study nine of 41 (21.9%) were cured after aspiration and placebo injection. This finding is comparable with the Agrawal study [18]. The cure rates of phenol were better than polidocanol.

Sallami et al. [20] had much larger numbers of patients. Their cure rates after treating with polidocanol were 62.1% after a single treatment and 82.6% after multiple treatments.

Jahnson et al. [21] performed a randomised trial comparing 60 mg polidocanol in 2 ml to 120 mg polidocanol in 4 ml. The 120 mg dose had a statistically significant cure rate of 59% compared to 47% after a single treatment. The cure rate after four treatments was 89%. Minor complications predominantly epididymitis as well as a few cases or haematoma and pain occurred, but there was no statistical significance between the two groups.

Tetracyclines

Tetracyclines were initially used as sclerosants for pleurodesis of malignant pleural effusions [22]. They had been mooted as a cost effective treatment for hydroceles as well as being as effective as surgery [23]. Francis and Levine [23] had a success rate of 84% in their series of 32 hydroceles. They did not notice any difference in recurrence rates for larger hydroceles. The majority of their cases were below 300 ml. The recurrence rate below 300 ml was 13.6% compared to 40% for hydroceles greater than 300 ml.

Osman [24] performed a prospective randomised study of 79 patients comparing surgical repair to aspiration and sclerotherapy with tetracycline. He experienced a high recurrence rate of 67.4% as well as severe pain in his cohort. He used a mixture of tetracycline and xylocaine in the injection and still had variations in severe pain from one h to two days.

Shokeir et al. [25] had a cure rate of 90% in their series. This was however after multiple treatments. Results after a single treatment dropped to 57%. He found that if the aspirated volume of the hydrocele was over 150 ml, there was a greater need for repeated treatments. The other main complication was severe scrotal pain, which occurred in a third of his patients.

Ali et al. [26] published their series of 30 patients. Forty percent had mild pain, 46% moderate pain, and 13% had severe pain post procedure despite a local anaesthetic cord block. They had a cure rate of 100% although there was a 6.6% minor mild recurrence at 6 months, although these patients were still satisfied. The only patients who were not satisfied were 50% of the severe post procedure pain group.

East and DuQuesnay [27] performed a comparison of tetracycline v phenol sclerotherapy for treatment of hydrocele and epididymal cysts. The cure rate after a single injection was better in the tetracycline group (88.6% compared with 70.5). After a second treatment, the results were similar 97.7 for the phenol group and 94.3 in the tetracycline group. The first five patients in the tetracycline group experienced severe scrotal pain and so for the patients in this group after a cord block was given after aspiration of the hydrocele prior to the injection of the sclerosant. No cord block was required in the phenol group. One patient in the tetracycline group developed chronic pain in the testicle and was treated with orchidectomy. This study shows that both sclerosants work well and can be considered as an alternative to surgery as long as the patient understands the risks.

Ethanolamine

Ethanolamine was predominantly used as a sclerosant for the treatment of varicose veins and vascular malformations. Hellström et al. [28] first used this as a treatment for hydroceles. Hellström et al. [28] treated 11 hydroceles and cured all of them with ethanolamine.

Hellström furthered his work in this area with Tammela et al. [29]. They treated 102 hydroceles with 5% ethanolamine solution. They cured 98% of hydroceles. 68% were cured after a single treatment. Half of the patients experienced pain after treatment and there was a low risk of haematoma and infection 3% and 2%, respectively.

Sodium tetradecyl sulphate

Sodium tetradecyl sulphate is the only FDA approved sclerosant in the USA.

Braslis and Moss [30] used STDS and treated 102 hydroceles and epididymal cysts. The cure rate at a single treatment was 76% and 94% after multiple treatments. They used STDS 10 ml for hydroceles greater than 50 ml. In 80% of the cases, they also mixed the STDS with 1 ml 1% lignocaine. Patients who did not have any local anaesthetic mixed with the STDS experienced pain for up to six h after the procedure. No patient had any pain when 1 ml of 1% lignocaine was used mixed with STDS.

Stattin et al. [31] reviewed the long-term follow up of STDS with a postal questionnaire. In their cohort of 106 patients, 96% of patients responded at a mean time of 40 months post procedure. They had a 95% satisfaction rate. Mean pain score on visual analogue scale of 1–10 was 1.9. overall success rate of the procedure was 88%. They had two (1.9%) severe complications of orchitis requiring orchidectomy in diabetic patients.

Beiko et al. [32] compared aspiration and sclerotherapy with surgical hydrocele repair. Twenty eight hydroceles were treated with STDS and 25 had surgical hydrocele repair. They found that success of STDS was 76% compared to 88% for surgery. Complications however were much lower in the STDS group compared to surgery with 8% compared to 40% in aspiration group. They also estimated the cost at being nine times lower than surgery.

Khaniya et al. [33] performed a randomised controlled study comparing aspiration and sclerotherapy with STDS to surgical Jaboulay repair. They had 30 patients in each group. Aspiration and sclerotherapy were performed by injecting 50% of the amount of the fluid aspirated up to a maximum of 80 ml. They used 4 ms of 3% STDS and 6 ml of 2% lignocaine. This was added to 70 ms 0.9% saline. There was no difference between the patient groups in terms of patient age, size of hydrocele, duration of symptoms or number of hydroceles. Complications were less in the aspiration and sclerotherapy group. Eight patients developed fever in the surgery group compared to two in the STDS group. The incidence of pain and haematocele was comparable between the two groups. Nine (34.6) of the sclerotherapy group developed recurrence at 3 months follow up. For this reason, the satisfaction was higher in the surgery group despite the higher complication rate. For this reason, the authors suggest that aspiration and sclerotherapy are an option for people with no access to surgery but advocate surgery as the gold standard of treatment.

Musa et al. [34] carried out a prospective study of 57 patients treated with STDS. They used 3% STDS and injected 2 ml for hydroceles less than 200 ml, 3 ml for hydroceles 201–300 ml and 3 ml for hydroceles greater than 300 ml. They followed patients up at 1 week, 1 month, 3 months, and 6 months. Sixty three percent were cured at 6 months. Repeat aspiration and sclerotherapy were carried out and gave an 84.2% cure rate after the second treatment. 43.9% of patients developed redness and inflammation when reviewed after 1 week. No patients experienced pain.

Discussion

There is a wealth of literature describing aspiration and sclerotherapy for the treatment of hydroceles. Comparing the literature is very difficult as the patient numbers in each study are relatively small. There are also lots of different variables within the studies. Often the same sclerosant is used in different concentrations and different cocktails of local anaesthetic or other additives. There is also great variation in the size of the hydrocele that is being treated and we know that larger hydroceles treated with aspiration and sclerotherapy have a greater chance of needing further treatment. The follow up and timing of recurrence is also not clear in the studies and often not documented. It is worth considering that larger hydroceles that undergo surgical repair have a greater chance of complications as well.

There may be bias in patient selection of some of these series and studies as younger patients are more likely to choose surgery and the older unfit patient more likely to choose aspiration and sclerotherapy. Younger patients may also be persuaded to have surgery due to the risk of chemical epididymitis and concerns over fertility after this complication. Younger patients potentially may have more side effects from aspiration and sclerotherapy as they may be more active or need to get back to work and this may affect recurrence and inflammation post procedure.

Within the UK and NHS, budgets are tighter and treatments are starting to be rationed. Theatre time is prioritised for cancer treatment and so the wait for benign surgery is getting longer. Therefore, if procedures can be carried out in the outpatient clinic this could be beneficial to the patient as they get their treatment faster but also to other patients who need theatre. Cost should also be considered. Theatre time is more expensive than outpatients and so the cost of aspirations and sclerotherapy is less than for surgery. The need for further treatments should be considered however as patients may need further outpatient visits and patients undergoing surgery for hydrocele are usually followed up in primary care in the UK.

Conclusions

This review shows that STDS has a stronger evidence base behind it in the literature than the other sclerosants. Braslis and Moss [30] cocktail of 1 ml 1% lignocaine with 10 ml STDS for hydroceles greater than 50 ml on balance is the most effective formula as it has few side effects. This has a 76% cure rate after a single treatment 94% after multiple treatments. Stattin et al. [31] showed long-term satisfaction at 40 months of treatment with STDS was 95%. Complications from this were low compared to other sclerosants. The main complication associated with aspiration and sclerotherapy was pain and this was less common with STDS. Other complications including haematoma and infection were rare.

Informed consent is essential when explaining the options of treatment for a hydrocele. Aspiration and sclerotherapy should be discussed with every patient as an alternative to surgery. Patient selection is essential for this procedure, an older man with a moderate hydrocele may have a very good result with aspiration and sclerotherapy. In young patients who have not yet started a family or who fertility is still a consideration should be explained the risks of chemical epididymitis and the problems this can cause, they would therefore be poor candidates for sclerotherapy. Patients with poorly controlled diabetes have a risk of a severe infection requiring orchidectomy and therefore may be better treated with surgical repair. They would however also have a higher chance of complication from surgery as a results of their diabetes.

Surgical treatment does have better long-term outcomes than aspiration and sclerotherapy but this literature review has shown a role over and above just patients who are not fit for a general anaesthetic who need treatment for their hydrocele. With scarce health resources greater consideration should be given to aspiration and sclerotherapy.

Disclosure statement

The authors declared no sponsorship or conflict of interest.