A Randomized Controlled Trial Comparing Combined Spongiosum Block and Intraurethral Lignocaine with Intraurethral Lignocaine Alone in Optical Internal Urethrotomy for Urethral Stricture

Introduction

T he term urethral stricture refers to a scarring process that involves the spongy erectile tissue of the corpus spongiosum. Any process that results in injury to the urethral epithelium or underlying corpus spongiosum, to the extent that healing results in the formation of scar, can result in stricture. For an appropriate treatment plan to be devised, it is important to determine the location, length, depth, and density of the stricture. ¹ Optical internal urethrotomy (OIU) is the most commonly performed procedure for the management of anterior urethral stricture. ² It is usually performed under spinal or general anesthesia. Intraurethral lignocaine and spongiosum block have been shown to be safe and efficacious anesthesia methods for performing OIU, ^3,4 although there have been no comparative studies between the two methods. We performed this study to compare the safety and efficacy of spongiosum block with intraurethral lignocaine and intraurethral lignocaine in patients who were undergoing OIU.

Patients and Methods

All male patients with anterior urethral stricture, including penile, bulbar, and bulbomembranous urethral stricture, planned for OIU between July 2009 and December 2010 were included in the study. After getting Institutional Ethics Committee clearance and informed consent from each patient, the patients were randomized into two groups. Randomization was performed according to a computer-generated set of random numbers in blocks of five. Each number was put in an opaque envelope that was numbered serially.

Spongiosum block was given as described previously. ⁴ In group 1, a 26-gauge hypodermic needle was used, and 3 mL of 2% lignocaine was slowly injected into the glans over 1 minute followed by 15 mL intraurethral lignocaine jelly and a single layer of gauze applied over the base of penis, over which a rubber band was applied to achieve venous blockade to prevent rapid loss of anesthetic agent into the systemic circulation via the dorsal penile veins. To avoid bleeding, the glans was squeezed with the swab for 1 to 3 minutes. In group 2, only 15 mL of 2% intraurethral lignocaine jelly was given.

OIU was performed using a cold-cutting urethrotome. The urethrotome with its cold knife was placed up the urethra as far as the stricture, which was carefully cut at the 12 o' clock position until the full thickness of the fibrous scar was divided and normal tissue below the stricture was reached. An 18F silicone Foley catheter was left in place for 5 days. Postoperative pain was analyzed on a visual analogue scale (VAS) from 0 to 10 (0=no pain to 10=severe pain).

All the procedures were undertaken in an outpatient setting, and patients were discharged with an indwelling catheter after completion of the OIU. Antibiotic coverage with an ofloxacin 400 mg (sustained release) tablet once daily was provided until the catheter was removed. The patients were followed for at least 6 months. Postprocedure evaluation was performed by uroflowmetry and urethral calibration. Retrograde urethrography and micturating cystourethrography were performed as per requirement. Any symptoms pertaining to recurrence were noted as reduced stream of urine, retention of urine, or burning micturition. The procedure was considered successful if the patient did not report any voiding difficulty and urethral calibration was easy with an 18F Foley catheter.

Continuous data were expressed as mean (±standard deviation). Categorical variables were analyzed by the chi-square test or the Fisher exact test, and continuous variables by the Student t test. Comparative analysis between two groups was performed using the independent t-test or Mann-Whitney U test. All statistical tests were two-tailed, and P values of<0.05 were taken as significant.

Results

The study included 50 patients with 25 patients in each group. The mean age of the patients in group 1 was 44.20 years (range 18–77 y) and that of group 2 was 43.68 years (range 18–75 y) (P=0.922). There was no significant difference between the two groups in the type, site, etiology, and length of the urethral stricture (Table 1). Most of the patients in the two groups had trauma (n=19) or inflammation (n=15) as the cause of urethral stricture; the stricture was most commonly located in the bulbar urethra (n=39), length of the stricture being most commonly 1 to 3 cm (n=37).

Using the VAS, the score was assessed in the two groups and the mean score evaluated. VAS scores between 1 to 3, 4 to 7, and 8 to 10 were considered as mild, moderate, and severe pain, respectively. The VAS scores in group 1 (1.5±1.4) were significantly lower than the VAS scores in group 2 (2.7±1.8) (P=0.006) (Table 2). In the spongiosum block group, 8 patients had no pain during the procedure, 14 patients had mild pain, 3 had moderate pain, and none had severe pain. Two patients in group 1 complained of tingling sensation during injection of 1% lignocaine into the glans. Recurrence of stricture was noted in three (12%) patients at follow-up and was managed with repeated OIU at a later date.

In group 2, 3 patients had no pain, 15 had mild pain, 6 had moderate pain, and 1 patient had severe pain. The patient who experienced severe pain was 76 years old and had a history of diabetes and hypertension. He needed intravenous sedation and analgesics for the control of the pain. Myocardial infarction developed in this patient in the recovery room after the procedure. The patient was admitted; intensive monitoring of vital signs was performed and necessary treatment given. The patient succumbed after 4 days of hospital stay. Three other patients in group 2 needed intravenous analgesics during the procedure. In group 2, recurrence of urethral stricture developed in five (20%) patients. The stricture recurrence was most common in patients with stricture involving the membranous urethra.

Discussion

Urethral stricture disease continues to be a significant burden on the healthcare resources of both developing and developed countries. Urethroplasty has a low recurrence rate, but it is costly, technically demanding, and time consuming. Comparatively fewer patients can be treated by this modality in a given time. In a busy practice with many urethral strictures, the choice of a simple but effective initial procedure and maintenance of low recurrence rates are particularly important for efficient management of time and resources. ⁵ The advantages of OIU include less invasiveness, short procedure time, less morbidity, and reasonable success rate. The ability to perform this procedure under local anesthesia offers the additional benefits of reduced demand on operating theater slots and rapid day-case surgery. ⁶

Under intracorpus spongiosum block anesthesia, minor procedures on the anterior urethra in an outpatient setting offer several advantages compared with the same procedure under general or spinal anesthesia in the operating room. ⁷ The risks of general or spinal anesthesia and common postoperative nausea or headache are avoided. The anxiety and discomfort associated with general anesthetic induction are eliminated. Also, the time requirement for the patient or family is decreased, because an urologist can perform both anesthesia and surgical manipulations during the patient's initial office visit. ⁷ The patient can go back to work shortly after receiving the procedures. Finally, total cost will be markedly reduced, because anesthesia in an operating room and hospital stay are not needed.

Local anesthesia using lignocaine jelly had been used for urethral strictures with a good success rate. In a study by Altinova and associates, ³ a series of 28 patients underwent 32 internal urethrotomy procedures under local urethral anesthesia with intraurethral lignocaine. The patient age ranged from 31 to 83 years (median age 63 y). All the strictures were shorter than 2 cm in length. Lignocaine gel (12.5 g, 2%) was instilled through the urethral meatus, and the penis was clamped for 10 minutes thereafter. The VAS was used for the evaluation of pain. All the patients were followed for at least 6 months. The overall success rate was 92.9%. A total of 25 patients experienced mild pain and two had moderate pain. ³

In a study by Munks and colleagues, ⁶ OIU was performed in urethral strictures under local anesthesia in 33 patients with an average age of 51.8 years. The majority of the strictures were located in the bulbar (10) or penobulbar urethra (11), and five patients had penile stricture. Seven patients had more than one stricture. Despite the extensive nature of the majority of the strictures, the procedure was successful in all but 3 of the 33 (91%) patients. Postoperative urinary tract infections developed in two patients, and there was one early recurrence for which the patient needed urethroplasty. Only six patients gave a VAS of more than 3 of 10. Nine patients reported no discomfort during the procedure. The average VAS for the 33 patients was 2 of 10. ⁶

In our present study, of 25 patients in group 2 who underwent OIU under local anesthesia using intraurethral 2% lignocaine jelly, 6 patients experienced moderate pain and 1 patient had severe pain in the intraoperative period. The overall success rate was 80%, with recurrence developing in five patients in the follow-up period.

Ye and coworkers ⁴ described the technique of spongiosum block anesthesia, which is based on the male urethral anatomy. The anterior urethra is composed of urethral epithelium and underlying corpus spongiosum. At the distal end, the corpus spongiosum expands to form the glans penis. When the lignocaine is injected subcutaneously into the spongiosum of the glans, it spreads through the venous sinuses and rapidly anesthetizes the sensory nerve endings in the anterior urethra. In the initial study by Ye and coworkers, ⁴ OIU was performed under intracorpus spongiosum block anesthesia in an outpatient setting in 23 patients with anterior urethral stricture. A dosage of 3 mL of 1% lignocaine solution was injected slowly into the glans penis. Optical urethrotomy was then performed with a cold cutting knife. The internal urethrotomy was completed successfully in 23 patients. Twenty-two (95.7%) patients experienced no pain or discomfort. In one patient, there was minimal but tolerable discomfort during the period when the tissue above the stricture was cut. The anesthesia, which lasted approximately 1.5 hours, proved very satisfactory; there were no complications. ⁴

In another study by Ye and colleagues, ⁸ in which 51 patients were included, the outcome of intracorpus spongiosum block anesthesia had been very good. The anesthetic effect was immediate after the subcutaneous injection of 1% lignocaine into the corpus spongiosum of the glans. Under this anesthesia, all the minor procedures that varied from 10 to 120 minutes (mean 33 min) were successfully completed without any premedication or additional intravenous sedation. Forty-seven (92.2%) patients had no pain, and four patients (7.8%) had either minor (5.9%) or moderate discomfort (1.9%) during the procedures; the discomfort was limited and tolerable.

In the series of Ye and colleagues, ⁸ one patient with penoscrotal urethral stricture (2 cm long) had moderate discomfort when the surrounding tissue above the strictured area was being incised. Injection of a second dose of lignocaine could not eliminate it. After a dose of 1 mL of 1% lignocaine was injected via the perineum into the bulbous corpus spongiosum above the strictured area, the patient's pain resolved completely. ⁸ The probable explanation was that the anesthetic agent could not spread proximal to the region of complete spongiosal fibrosis.

In our study, we did not encounter a similar problem. This could have been because of the absence of any patient with such a severe spongiosal fibrosis and the addition of intraurethral lignocaine, which can spread intraluminally.

Ather and associates ⁷ compared optical urethrotomy performed under general/major regional anesthesia in 16 patients (group 1) and a spongiosum block and sedation in 16 (group 2). In group 2, a total of 2 to 3 mL 1% lignocaine were slowly injected into the glans penis. Standard optical urethrotomy was performed immediately with a cold cut knife. The two groups were matching in terms of patient age, and stricture cause and length. Optical urethrotomy was successfully completed in all patients in group 1 and in 15 of 16 in group 2. In group 2, 15 patients (94%) had no pain or discomfort. One patient reported moderate discomfort and the procedure had to be abandoned. In group 2, none of the patients required parenteral analgesia postprocedure. The first year recurrence was not significantly different in the two groups. The anesthetic effect lasted for about an hour and was satisfactory without any complications. Pain score on the VAS was not different between the two groups. ⁷

Another anesthetic technique, the transperineal urethrosphincteric block, has been described for performing OIU. ⁹ Using this techniques, although the mean VAS score reported was one (two patients had a score of five), the procedure needs two injections, use of a spinal needle, has pain associated with injection, and uses a larger volume of lignocaine (10 and 20 mL). ⁹ Compared with this technique, spongiosum block provides equivalent results with a simple technique and using a small volume of anesthetic agent.

In our present study, the procedure was successfully performed in all patients with minimal to mild pain in group 1. In group 2, three patients needed intravenous analgesics, and myocardical infarction developed in one patient. Although he had high risk factors for myocardial infarction such as old age, hypertension, and diabetes, we believe that most probably, the pain could have been the precipitating cause for the event. Although OIU under intraurethral lignocaine has been shown to be safe in previous studies, the above complication should be kept in mind while performing procedures in high-risk patients. This complication and the overall lower pain score in group 1 makes spongiosum block with intraurethral lignocaine the preferred approach over intraurethral lignocaine alone. The only side effect of intraurethral lignocaine that we observed was a tingling sensation in the glans, which occurred in three patients. This was probably because of the relatively rapid injection and can probably be prevented by still slower injection of lignocaine. This side effect needs to be explained to the patients before injection.

In a series of 69 patients who underwent spongiosum anesthesia, there were no serious complications related to the anesthetic technique, except for 3 (4.3%) patients who had instantaneous trance during the injection. ¹⁰ None of the patients had spongiofibrosis resulting from intracorpus spongiosum anesthesia during a 6-month follow-up. ¹⁰

Conclusions

Combined spongiosum block with intraurethral lignocaine anesthesia is a simple, safe, and efficacious anesthesia technique for surgical procedures on the anterior urethra. It has better anesthetic efficacy when compared with intraurethral lignocaine anesthesia. Spongiosum block with intraurethral lignocaine is a viable alternative for regional and general anesthesia in the management of anterior urethral stricture with OIU.