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Randomized Clinical Trial Comparing Effectiveness of Intracorpus Spongiosum Block Versus Topical Anesthesia for Performing Visual Internal Urethrotomy for Urethral Stricture Disease
Reconstructive Urology Randomized Clinical Trial Comparing Effectiveness of Intracorpus Spongiosum Block Versus Topical Anesthesia for Performing Visual Internal Urethrotomy for Urethral Stricture Disease Bastab Ghosh, Lalgudi N. Dorairajan, Santosh Kumar, Ramanitharan Manikandan, Kaliyaperumal Muruganandham, and Avijit Kumar OBJECTIVE METHODS
RESULTS
CONCLUSION
To compare the efficacy and safety of intracorpus spongiosum block (ICSB) over topical anesthesia for performing visual internal urethrotomy (VIU) in a randomized clinical trial. VIU for urethral stricture can be performed under various types of anesthesia, including topical anesthesia. Although recent studies have shown that ICSB and general anesthesia have comparable efficacy for performing VIU, no studies have compared ICSB with topical anesthesia. Forty consenting patients with single, short, passable anterior urethral stricture were randomized into two groups. Group 1 patients received topical 2% lignocaine jelly and group 2 patients received 1% lignocaine ICSB for undergoing VIU. Pain perception during and after the procedure was assessed by visual analog scale (VAS). The changes in vital parameters during the procedure and procedure-related complications were recorded. Statistical analysis was done using the Mann-Whitney test or t test. The mean standard deviation VAS scores intraoperatively (2.85 1.34) and at 1-hour postoperatively (1.17 0.96) were significantly lower (P <.01) in group 2 patients than the corresponding scores in group 1 (4.9 1.9 and 2.35 1.34 respectively). The intraoperative rise in pulse rate and in blood pressure were significantly greater (P <.05) in group 1 patients (13 5.1/min and 11.3 6.44 mm Hg) than in group 2 (8.05 5.54/min and 6.35 5.86 mm Hg). ICSB is safe and more effective than topical anesthesia for providing pain relief during VIU. This should become the local anesthesia technique of choice for performing VIU. UROLOGY 81: 204e207, 2013. 2013 Elsevier Inc.
V
isual internal urethrotomy (VIU) is one of the most commonly practiced treatments for urethral stricture disease.1 It is most useful for shortsegment bulbar urethral strictures. Traditionally, VIU is performed under general or regional anesthesia.2 Several authors have shown that VIU can be performed successfully under topical anesthesia to reduce the cost and hospital stay.2-4 In our institution, we have been performing VIU under topical anesthesia, but some patients expressed dissatisfaction with the anesthetic effect and reported experiencing significant pain during the procedure. A few studies have described the procedure under intracorpus spongiosum block (ICSB), with fairly good
analgesic effect.5,6 This novel technique was described as a simple, inexpensive, safe, and effective procedure with efficacy comparable to general or spinal anesthesia in a recent nonrandomized study.7 One study recently compared the efficacy of combined ICSB and topical anesthesia with topical anesthesia alone and reported significantly less pain in the combined anesthesia group.8 In the present study, we wished to find out if the technique of ICSB is safe and comparable or better than topical anesthesia in a randomized clinical trial.
MATERIAL AND METHODS Study Design
Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India Reprint requests: Lalgudi N. Dorairajan, M.Ch., Professor of Urology, JIPMER, Puducherry 605006, India. E-mail: [email protected] Submitted: August 5, 2012, accepted (with revisions): September 19, 2012
204
ª 2013 Elsevier Inc. All Rights Reserved
After obtaining Institutional Review Board approval, we approached and assessed patients who required VIU for the treatment of urethral stricture disease as determined by the usual policy of the department. All patients aged older than 18 years with single passable anterior urethral stricture of 2 cm or less were assessed. Detailed history and examination was obtained to 0090-4295/12/$36.00 http://dx.doi.org/10.1016/j.urology.2012.09.020
ascertain stricture etiology and associated comorbidities. The stricture length, location (proximal bulbar, midbulbar, and distal bulbar/penobulbar), and passability were determined by retrograde urethrography (RGU). Sterile urine was mandatory before surgical intervention. The study excluded patients with multiple strictures, stricture of fossa navicularis, stricture length of more than 2 cm, known allergy to lignocaine, associated urologic comorbidities (eg, urethral or vesical calculus, benign prostatic hyperplasia, and neurovesical dysfunction), and patients with significant cardiovascular disease. After patients provided written informed consent, they were randomized into 1 of 2 groups. Group 1 patients received topical anesthesia by instillation of 2% lignocaine jelly, and group 2 patients received ICSB with 1% lignocaine injection as an anesthetic agent before VIU was performed. The sample size of 60 (30 in each group) was originally planned on the basis of similar studies performed previously. However, the study was terminated with a highly significant difference being noted on interim analysis after 40 patients were recruited. The 40 patients were prospectively randomized into 2 groups of 20 patients each, based on computer-generated random numbers using block randomization with block size of 10. Allocation concealment was executed by using sealed envelopes that were opened in the operating room by the surgeon performing the procedure after the patient consented to participate in the study.
Detailed Technique of Anesthesia and Surgical Procedure All the patients received an intravenous morphine injection (0.1 mg/kg of body weight) 20 minutes before the procedure to reduce anxiety. Pulse rate and blood pressure were monitored before starting and throughout the procedure. Changes in vital parameters were also recorded throughout the procedure. All patients received preoperative antibiotics. In group 1 patients, 2% lignocaine jelly (10 mL) was instilled through the urethral meatus, and the meatus was kept clamped for 10 minutes to allow the anesthetic agent to act. In group 2 patients, 1% lignocaine (3 mL) was injected using a 26-gauge needle on the dorsal surface of the glans penis, slowly over a period of 1 minute. The glans penis was compressed for 10 minutes for the bleeding to stop and to achieve the desired anesthetic effect. In this group, water-soluble nonanesthetic lubricant jelly was used for introduction of the VIU sheath. All the procedures were done with the patient in the lithotomy position. A standard Sachse urethrotomy knife was used under guidance of a 0.035-inch guidewire. A single 12 o’clock incision was made. Complete incision of the stricture was deemed achieved once the 21F sheath passed freely into the bladder. The procedure was concluded and an 18F Foley catheter was left for 5 days.
Parameters Studied and Statistical Analysis All patients were assessed in the recovery room 1 hour after the procedure for pain perception at that time and for pain perceived during the procedure with the help of a visual analog scale (VAS). The VAS consisted of scores 0 through 10, where 0 represents no pain and 10 reflects maximum pain. Assessment of pain was done 1 hour after the procedure by a nurse in the postoperative ward who was not involved in the surgical procedure. The increase in pulse rate (preoperative vs maximum perioperative pulse rate) and the change in systolic blood pressure (SBP) during the procedure compared with the baseline UROLOGY 81 (1), 2013
Assessed for eligibility (n= 47)
Excluded (n= 7) Not meeting inclusion criteria (n= 3) Declined to participate (n=4)
Randomized (n= 40)
Allocated to intervention (n=20)
Allocated to intervention (n= 20)
Received allocated intervention (n=20)
Received allocated intervention (n=20)
Analyzed (n= 20)
Analyzed (n=20)
Figure 1. Consolidated Standards of Reporting Trials (CONSORT) flow diagram shows patient involvement and exclusions in each group. were recorded for each patient as an objective indicator of the sympathetic response to pain. Intraoperative complications, if any, of VIU and of the anesthesia techniques were also recorded. Strictures were classified into 4 categories according to the etiology: traumatic, inflammatory, iatrogenic, and idiopathic. The stricture location was classified as proximal bulbar, midbulbar, and distal bulbar/ penobulbar stricture; however, this was not taken into consideration before randomization. Comparison of collected data between the 2 groups was done using the Mann-Whitney test or t test as appropriate for continuous variables. Statistical analysis of the VAS scores and other discrete variables were performed using the Mann-Whitney test. All statistical analyses were carried out at 5% level of significance, and a P value <.05 was considered significant.
RESULTS The study was conducted in a tertiary care institution. From January 2010 to July 2011, 47 patients were assessed. Three patients refused to participate in the study. Four patients were excluded because they did not meet eligibility criteria. The remaining 40 patients were randomized into 2 groups of 20 patients each (Fig. 1). The patients in both groups had matching baseline variables, including mean age, preoperative blood pressure and pulse rate, and length, location, and etiology of the stricture (Table 1). VIU was successfully completed in all patients in both groups. The mean (standard deviation) intraoperative VAS score was 2.85 1.34 in group 2, which was significantly less (P ¼ .0007) than the 4.9 1.9 score in group 1 (Fig. 2). The mean 1-hour postoperative VAS score was also significantly lower (P ¼ .0067) in group 2 patients (1.17 0.96) than in group 1 patients (2.35 1.34). Figure 3 gives the 1-hour postoperative VAS score of each 205
Table 1. Patient characteristics in both groups Variable Age, y Duration, mon Stricture length, cm Etiology Traumatic Inflammatory Iatrogenic Idiopathic Stricture location Proximal bulbar Midbulbar Distal bulbar/penobulbar Preoperative Pulse rate, beats/min SBP, mm Hg
Group 1 40.95 16.28 17.8 22.1 1.28 0.54
Group 2 46.2 15.03 36.5 75.6 1.35 0.51
5 4 2 9
3 3 5 9
9 8 3
3 10 7
75.15 10.74 130.35 10.12
72.45 7.45 131.45 9.97
P Value .73 .30 .46 .63
.09
.36 .73
SBP, systolic blood pressure. Continuous data are shown as the mean standard deviation and discrete data as number.
Figure 2. Comparative intraoperative visual analog scale (VAS) scores are shown for patients who received intracorpus spongiosum block (ICSB) and topical anesthesia (Topical). (Color version available online.)
Figure 3. The 1-hour postoperative pain scores on the visual analog scale (VAS) are shown for 20 consecutive patients who received intracorpus spongiosum block (ICSB) or topical anesthesia (Topical). (Color version available online.)
patient in the 2 groups. The change in pulse rate (preoperative vs maximum perioperative) was significantly greater in group 1 (13 5.1 beats/min) than in group 2 (8.05 5.54 beats/min, P ¼ .007). The change in SBP was also significantly higher in group 1 (11.3 6.44 mm Hg) than in group 2 (6.35 5.86 mm Hg, P ¼ .015). All patients were discharged the next day, according to institutional policy. The antibiotic was continued postoperatively until the catheter was removed. The Foley catheter was removed after 5 days in all patients except for a patient in group 2 who developed urinary extravasation (Clavien grade I). He was treated conservatively, and the urethral catheter was removed after 7 days. All patients voided well after catheter removal. No anesthesia-related complications were noted.
to perform, minimally invasive, and associated with shorter procedure time and less morbidity.8 Baring a few, contemporary studies have shown good long-term outcomes of VIU for short-segment strictures with superficial spongiofibrosis.9-13 When performed under local anesthesia, it reduces time in the operating theater and the risks and hazards associated with general or spinal anesthesia as well.4,7 Furthermore, performing VIU under general and regional anesthesia requires the presence of a qualified anesthesiologist and also increases the overall cost of the procedure substantially. To overcome this problem, a variety of local analgesic techniques have been applied.2-7,14 Ye et al5 showed the feasibility of ICSB for performing VIU. Ather et al7 compared ICSB with general anesthesia for VIU and showed this novel technique was equally effective and beneficial. They found this technique to be safe and costeffective, too. Recently, Kumar et al8 compared the spongiosum block along with intraurethral lignocaine vs intraurethral lignocaine alone. To date, however, no study has directly compared ICSB with topical anesthesia.
COMMENT After the introduction of VIU by Sachse, there was a tremendous enthusiasm to establish this procedure as a substitute of urethroplasty. The practice of VIU remains widespread and popular among urologists because it is easy 206
UROLOGY 81 (1), 2013
Most of the strictures in both groups of our study population were pure bulbar strictures. Although there was no restriction for selection, we did not find a suitable pure penile urethral stricture. Etiologically, most of the strictures were of idiopathic origin in both groups, with traumatic and inflammatory strictures following thereafter in the total number of cases. In the present study, we could finish the procedure in all patients, indicating the effectiveness of both techniques, and the procedures were performed by various surgeons, which reflects the easy applicability of both techniques. However, the intraoperative VAS score was significantly higher in the topical anesthesia group, reflecting the superior analgesic effect of ICSB compared with topical lignocaine anesthesia. The postoperative VAS scores were also significantly higher in the topical anesthesia group, representing the longer anesthetic effect of ICSB. Along with the subjective evidence of superior analgesic effect of ICSB, there were objective data too, as evidenced by the significantly higher change in pulse rate and SBP in the topical anesthesia group. No complication attributable to the anesthetic technique was encountered. One patient in the ICSB group developed urinary extravasation, which had no relationship the anesthesia technique. Although Ather et al7 and Kumar et al8 as well reported using a rubber tourniquet at the base of the penis to prevent the rapid washout of lignocaine to the venous blood, we did not find this was necessary. Instead, we injected lignocaine (on the glans) slowly over 10 minutes, which gave sufficient time for the drug to fix to the tissue. As a result, there was no lignocaine toxicity despite achieving good analgesic effect. We used a fixed dose of morphine in all patients as a departmental protocol, which contributed to the analgesic effect along with eliminating the anxiety. However, this analgesic effect of morphine was applicable to patients in both groups and is therefore unlikely to have had any effect on the analysis. We kept all patients admitted overnight due to hospital policy based on logistic reasons; however, there was no compelling reason to give any of the patients inhospital care. All of the patients were fit enough to be discharged after 1 hour. Although the outcome of VIU was not included in our study, only 2 patients, 1 from each group, had recurrent stricture throughout the study period of 1.5 years. All the patients were satisfied with the anesthetic effect of ICSB and agreed to opt for similar anesthesia if needed in future. However, documentation of such data was beyond the scope of this study. Being a surgical trial, it was not possible to blind the surgeon or the patient. We did not think it ethical to perform a sham injection in the topical group. However, the nurses in the postoperative ward who obtained the data on pain scores were not specifically informed about the type of anesthesia applied, and thus we tried to limit the bias. One limitation of our study is that we did not separately document the pain perceived while injecting on the glans for ICSB, which might have added some UROLOGY 81 (1), 2013
discomfort and may have been reflected in the VAS score. However, we believe that the pain due to the injection should have been reflected in the overall intraoperative and postoperative VAS scores. Yet, these scores were significantly less in the ICSB group than in the topical anesthesia group; therefore, the pain due to the glans injection was likely not very significant.
CONCLUSIONS The ICSB is a more effective technique than topical anesthesia for providing pain relief during VIU and is also a safe procedure. In view of its proven efficacy and safety, ICSB should be the preferred technique of anesthesia for VIU, particularly in patients at high risk for general anesthesia, such as those with significant pulmonary disease. However, this could also become the anesthesia technique of choice for performing VIU of anterior urethral strictures on an outpatient basis in general in view of the cost advantages. References 1. Dubey D. The current role of direct vision internal urethrotomy and self-catheterization for anterior urethral strictures. Indian J Urol. 2011;27:392-396. 2. Kreder KJ, Stack R, Thrasher JB, et al. Direct vision internal urethrotomy using topical anesthesia. Urology. 1993;42:548-550. 3. Greenland JE, Lynch TH, Wallace DM. Optical urethrotomy under local urethral anaesthesia. Br J Urol. 1991;67:385-388. 4. Munks DG, Alli MO, Abdel Goad EH. Optical urethrotomy under local anaesthesia is a feasible option in urethral stricture disease. Trop Doct. 2010;40:31-32. 5. Ye G, Rong-gui Z. Optical urethrotomy for anterior urethral stricture under a new local anesthesia: intracorpus spongiosum anesthesia. Urology. 2002;60:245-247. 6. Ye G, Shan-Hong Y, Xiang-Wei W, et al. Use of a new local anesthesia-intracorpus spongiosum anesthesia-in procedures on anterior urethra. Int J Urol. 2005;12:365-368. 7. Ather MH, Zehri AA, Soomro K, et al. The safety and efficacy of optical urethrotomy using a spongiosum block with sedation: a comparative nonrandomized study. J Urol. 2009;181:2134-2138. 8. Kumar S, Prasad S, Parmar K, et al. A prospective randomized controlled trial comparing combined spongiosum block and intraurethral lignocaine with intraurethral lignocaine alone in optical internal urethrotomy for stricture urethra. J Endourol. 2012;26: 1049-1052. 9. Chilton CP, Shah PJR, Fowler CG, et al. The impact of optical urethrotomy on the management of urethral strictures. Br J Urol. 1983;55:705-710. 10. Gaches CGC, Ashken MH, Dunn M, et al. The role of selective internal urethrotomy in the management of urethral stricture: a multicenter evaluation. Br J Urol. 1979;51:579-583. 11. Steencamp JW, Heyns CF, DeKock MI. Internal urethrotomy versus dilatation as treatment for male urethral strictures. A prospective randomized comparison. J Urol. 1997;157:98-100. 12. Santucci RA, Eisenberg L. Urethrotomy has a much lower success rate than previously reported. J Urol. 2010;183:1859-1862. 13. Bullock TL, Brandes SB. Adult anterior urethral strictures: a national practice patterns survey of broad certified urologists in the United States. J Urol. 2007;177:685-690. 14. Al-Hunayan A, Al-Awadi K, Al-Khayyat A, Abdulhalim H. A pilot study of transperineal urethrosphincteric block for visual internal urethrotomy in patients with anterior urethral strictures. J Endourol. 2008;22:1017-1020.
207
RESULTS
CONCLUSION
To compare the efficacy and safety of intracorpus spongiosum block (ICSB) over topical anesthesia for performing visual internal urethrotomy (VIU) in a randomized clinical trial. VIU for urethral stricture can be performed under various types of anesthesia, including topical anesthesia. Although recent studies have shown that ICSB and general anesthesia have comparable efficacy for performing VIU, no studies have compared ICSB with topical anesthesia. Forty consenting patients with single, short, passable anterior urethral stricture were randomized into two groups. Group 1 patients received topical 2% lignocaine jelly and group 2 patients received 1% lignocaine ICSB for undergoing VIU. Pain perception during and after the procedure was assessed by visual analog scale (VAS). The changes in vital parameters during the procedure and procedure-related complications were recorded. Statistical analysis was done using the Mann-Whitney test or t test. The mean standard deviation VAS scores intraoperatively (2.85 1.34) and at 1-hour postoperatively (1.17 0.96) were significantly lower (P <.01) in group 2 patients than the corresponding scores in group 1 (4.9 1.9 and 2.35 1.34 respectively). The intraoperative rise in pulse rate and in blood pressure were significantly greater (P <.05) in group 1 patients (13 5.1/min and 11.3 6.44 mm Hg) than in group 2 (8.05 5.54/min and 6.35 5.86 mm Hg). ICSB is safe and more effective than topical anesthesia for providing pain relief during VIU. This should become the local anesthesia technique of choice for performing VIU. UROLOGY 81: 204e207, 2013. 2013 Elsevier Inc.
V
isual internal urethrotomy (VIU) is one of the most commonly practiced treatments for urethral stricture disease.1 It is most useful for shortsegment bulbar urethral strictures. Traditionally, VIU is performed under general or regional anesthesia.2 Several authors have shown that VIU can be performed successfully under topical anesthesia to reduce the cost and hospital stay.2-4 In our institution, we have been performing VIU under topical anesthesia, but some patients expressed dissatisfaction with the anesthetic effect and reported experiencing significant pain during the procedure. A few studies have described the procedure under intracorpus spongiosum block (ICSB), with fairly good
analgesic effect.5,6 This novel technique was described as a simple, inexpensive, safe, and effective procedure with efficacy comparable to general or spinal anesthesia in a recent nonrandomized study.7 One study recently compared the efficacy of combined ICSB and topical anesthesia with topical anesthesia alone and reported significantly less pain in the combined anesthesia group.8 In the present study, we wished to find out if the technique of ICSB is safe and comparable or better than topical anesthesia in a randomized clinical trial.
MATERIAL AND METHODS Study Design
Financial Disclosure: The authors declare that they have no relevant financial interests. From the Department of Urology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India Reprint requests: Lalgudi N. Dorairajan, M.Ch., Professor of Urology, JIPMER, Puducherry 605006, India. E-mail: [email protected] Submitted: August 5, 2012, accepted (with revisions): September 19, 2012
204
ª 2013 Elsevier Inc. All Rights Reserved
After obtaining Institutional Review Board approval, we approached and assessed patients who required VIU for the treatment of urethral stricture disease as determined by the usual policy of the department. All patients aged older than 18 years with single passable anterior urethral stricture of 2 cm or less were assessed. Detailed history and examination was obtained to 0090-4295/12/$36.00 http://dx.doi.org/10.1016/j.urology.2012.09.020
ascertain stricture etiology and associated comorbidities. The stricture length, location (proximal bulbar, midbulbar, and distal bulbar/penobulbar), and passability were determined by retrograde urethrography (RGU). Sterile urine was mandatory before surgical intervention. The study excluded patients with multiple strictures, stricture of fossa navicularis, stricture length of more than 2 cm, known allergy to lignocaine, associated urologic comorbidities (eg, urethral or vesical calculus, benign prostatic hyperplasia, and neurovesical dysfunction), and patients with significant cardiovascular disease. After patients provided written informed consent, they were randomized into 1 of 2 groups. Group 1 patients received topical anesthesia by instillation of 2% lignocaine jelly, and group 2 patients received ICSB with 1% lignocaine injection as an anesthetic agent before VIU was performed. The sample size of 60 (30 in each group) was originally planned on the basis of similar studies performed previously. However, the study was terminated with a highly significant difference being noted on interim analysis after 40 patients were recruited. The 40 patients were prospectively randomized into 2 groups of 20 patients each, based on computer-generated random numbers using block randomization with block size of 10. Allocation concealment was executed by using sealed envelopes that were opened in the operating room by the surgeon performing the procedure after the patient consented to participate in the study.
Detailed Technique of Anesthesia and Surgical Procedure All the patients received an intravenous morphine injection (0.1 mg/kg of body weight) 20 minutes before the procedure to reduce anxiety. Pulse rate and blood pressure were monitored before starting and throughout the procedure. Changes in vital parameters were also recorded throughout the procedure. All patients received preoperative antibiotics. In group 1 patients, 2% lignocaine jelly (10 mL) was instilled through the urethral meatus, and the meatus was kept clamped for 10 minutes to allow the anesthetic agent to act. In group 2 patients, 1% lignocaine (3 mL) was injected using a 26-gauge needle on the dorsal surface of the glans penis, slowly over a period of 1 minute. The glans penis was compressed for 10 minutes for the bleeding to stop and to achieve the desired anesthetic effect. In this group, water-soluble nonanesthetic lubricant jelly was used for introduction of the VIU sheath. All the procedures were done with the patient in the lithotomy position. A standard Sachse urethrotomy knife was used under guidance of a 0.035-inch guidewire. A single 12 o’clock incision was made. Complete incision of the stricture was deemed achieved once the 21F sheath passed freely into the bladder. The procedure was concluded and an 18F Foley catheter was left for 5 days.
Parameters Studied and Statistical Analysis All patients were assessed in the recovery room 1 hour after the procedure for pain perception at that time and for pain perceived during the procedure with the help of a visual analog scale (VAS). The VAS consisted of scores 0 through 10, where 0 represents no pain and 10 reflects maximum pain. Assessment of pain was done 1 hour after the procedure by a nurse in the postoperative ward who was not involved in the surgical procedure. The increase in pulse rate (preoperative vs maximum perioperative pulse rate) and the change in systolic blood pressure (SBP) during the procedure compared with the baseline UROLOGY 81 (1), 2013
Assessed for eligibility (n= 47)
Excluded (n= 7) Not meeting inclusion criteria (n= 3) Declined to participate (n=4)
Randomized (n= 40)
Allocated to intervention (n=20)
Allocated to intervention (n= 20)
Received allocated intervention (n=20)
Received allocated intervention (n=20)
Analyzed (n= 20)
Analyzed (n=20)
Figure 1. Consolidated Standards of Reporting Trials (CONSORT) flow diagram shows patient involvement and exclusions in each group. were recorded for each patient as an objective indicator of the sympathetic response to pain. Intraoperative complications, if any, of VIU and of the anesthesia techniques were also recorded. Strictures were classified into 4 categories according to the etiology: traumatic, inflammatory, iatrogenic, and idiopathic. The stricture location was classified as proximal bulbar, midbulbar, and distal bulbar/ penobulbar stricture; however, this was not taken into consideration before randomization. Comparison of collected data between the 2 groups was done using the Mann-Whitney test or t test as appropriate for continuous variables. Statistical analysis of the VAS scores and other discrete variables were performed using the Mann-Whitney test. All statistical analyses were carried out at 5% level of significance, and a P value <.05 was considered significant.
RESULTS The study was conducted in a tertiary care institution. From January 2010 to July 2011, 47 patients were assessed. Three patients refused to participate in the study. Four patients were excluded because they did not meet eligibility criteria. The remaining 40 patients were randomized into 2 groups of 20 patients each (Fig. 1). The patients in both groups had matching baseline variables, including mean age, preoperative blood pressure and pulse rate, and length, location, and etiology of the stricture (Table 1). VIU was successfully completed in all patients in both groups. The mean (standard deviation) intraoperative VAS score was 2.85 1.34 in group 2, which was significantly less (P ¼ .0007) than the 4.9 1.9 score in group 1 (Fig. 2). The mean 1-hour postoperative VAS score was also significantly lower (P ¼ .0067) in group 2 patients (1.17 0.96) than in group 1 patients (2.35 1.34). Figure 3 gives the 1-hour postoperative VAS score of each 205
Table 1. Patient characteristics in both groups Variable Age, y Duration, mon Stricture length, cm Etiology Traumatic Inflammatory Iatrogenic Idiopathic Stricture location Proximal bulbar Midbulbar Distal bulbar/penobulbar Preoperative Pulse rate, beats/min SBP, mm Hg
Group 1 40.95 16.28 17.8 22.1 1.28 0.54
Group 2 46.2 15.03 36.5 75.6 1.35 0.51
5 4 2 9
3 3 5 9
9 8 3
3 10 7
75.15 10.74 130.35 10.12
72.45 7.45 131.45 9.97
P Value .73 .30 .46 .63
.09
.36 .73
SBP, systolic blood pressure. Continuous data are shown as the mean standard deviation and discrete data as number.
Figure 2. Comparative intraoperative visual analog scale (VAS) scores are shown for patients who received intracorpus spongiosum block (ICSB) and topical anesthesia (Topical). (Color version available online.)
Figure 3. The 1-hour postoperative pain scores on the visual analog scale (VAS) are shown for 20 consecutive patients who received intracorpus spongiosum block (ICSB) or topical anesthesia (Topical). (Color version available online.)
patient in the 2 groups. The change in pulse rate (preoperative vs maximum perioperative) was significantly greater in group 1 (13 5.1 beats/min) than in group 2 (8.05 5.54 beats/min, P ¼ .007). The change in SBP was also significantly higher in group 1 (11.3 6.44 mm Hg) than in group 2 (6.35 5.86 mm Hg, P ¼ .015). All patients were discharged the next day, according to institutional policy. The antibiotic was continued postoperatively until the catheter was removed. The Foley catheter was removed after 5 days in all patients except for a patient in group 2 who developed urinary extravasation (Clavien grade I). He was treated conservatively, and the urethral catheter was removed after 7 days. All patients voided well after catheter removal. No anesthesia-related complications were noted.
to perform, minimally invasive, and associated with shorter procedure time and less morbidity.8 Baring a few, contemporary studies have shown good long-term outcomes of VIU for short-segment strictures with superficial spongiofibrosis.9-13 When performed under local anesthesia, it reduces time in the operating theater and the risks and hazards associated with general or spinal anesthesia as well.4,7 Furthermore, performing VIU under general and regional anesthesia requires the presence of a qualified anesthesiologist and also increases the overall cost of the procedure substantially. To overcome this problem, a variety of local analgesic techniques have been applied.2-7,14 Ye et al5 showed the feasibility of ICSB for performing VIU. Ather et al7 compared ICSB with general anesthesia for VIU and showed this novel technique was equally effective and beneficial. They found this technique to be safe and costeffective, too. Recently, Kumar et al8 compared the spongiosum block along with intraurethral lignocaine vs intraurethral lignocaine alone. To date, however, no study has directly compared ICSB with topical anesthesia.
COMMENT After the introduction of VIU by Sachse, there was a tremendous enthusiasm to establish this procedure as a substitute of urethroplasty. The practice of VIU remains widespread and popular among urologists because it is easy 206
UROLOGY 81 (1), 2013
Most of the strictures in both groups of our study population were pure bulbar strictures. Although there was no restriction for selection, we did not find a suitable pure penile urethral stricture. Etiologically, most of the strictures were of idiopathic origin in both groups, with traumatic and inflammatory strictures following thereafter in the total number of cases. In the present study, we could finish the procedure in all patients, indicating the effectiveness of both techniques, and the procedures were performed by various surgeons, which reflects the easy applicability of both techniques. However, the intraoperative VAS score was significantly higher in the topical anesthesia group, reflecting the superior analgesic effect of ICSB compared with topical lignocaine anesthesia. The postoperative VAS scores were also significantly higher in the topical anesthesia group, representing the longer anesthetic effect of ICSB. Along with the subjective evidence of superior analgesic effect of ICSB, there were objective data too, as evidenced by the significantly higher change in pulse rate and SBP in the topical anesthesia group. No complication attributable to the anesthetic technique was encountered. One patient in the ICSB group developed urinary extravasation, which had no relationship the anesthesia technique. Although Ather et al7 and Kumar et al8 as well reported using a rubber tourniquet at the base of the penis to prevent the rapid washout of lignocaine to the venous blood, we did not find this was necessary. Instead, we injected lignocaine (on the glans) slowly over 10 minutes, which gave sufficient time for the drug to fix to the tissue. As a result, there was no lignocaine toxicity despite achieving good analgesic effect. We used a fixed dose of morphine in all patients as a departmental protocol, which contributed to the analgesic effect along with eliminating the anxiety. However, this analgesic effect of morphine was applicable to patients in both groups and is therefore unlikely to have had any effect on the analysis. We kept all patients admitted overnight due to hospital policy based on logistic reasons; however, there was no compelling reason to give any of the patients inhospital care. All of the patients were fit enough to be discharged after 1 hour. Although the outcome of VIU was not included in our study, only 2 patients, 1 from each group, had recurrent stricture throughout the study period of 1.5 years. All the patients were satisfied with the anesthetic effect of ICSB and agreed to opt for similar anesthesia if needed in future. However, documentation of such data was beyond the scope of this study. Being a surgical trial, it was not possible to blind the surgeon or the patient. We did not think it ethical to perform a sham injection in the topical group. However, the nurses in the postoperative ward who obtained the data on pain scores were not specifically informed about the type of anesthesia applied, and thus we tried to limit the bias. One limitation of our study is that we did not separately document the pain perceived while injecting on the glans for ICSB, which might have added some UROLOGY 81 (1), 2013
discomfort and may have been reflected in the VAS score. However, we believe that the pain due to the injection should have been reflected in the overall intraoperative and postoperative VAS scores. Yet, these scores were significantly less in the ICSB group than in the topical anesthesia group; therefore, the pain due to the glans injection was likely not very significant.
CONCLUSIONS The ICSB is a more effective technique than topical anesthesia for providing pain relief during VIU and is also a safe procedure. In view of its proven efficacy and safety, ICSB should be the preferred technique of anesthesia for VIU, particularly in patients at high risk for general anesthesia, such as those with significant pulmonary disease. However, this could also become the anesthesia technique of choice for performing VIU of anterior urethral strictures on an outpatient basis in general in view of the cost advantages. References 1. Dubey D. The current role of direct vision internal urethrotomy and self-catheterization for anterior urethral strictures. Indian J Urol. 2011;27:392-396. 2. Kreder KJ, Stack R, Thrasher JB, et al. Direct vision internal urethrotomy using topical anesthesia. Urology. 1993;42:548-550. 3. Greenland JE, Lynch TH, Wallace DM. Optical urethrotomy under local urethral anaesthesia. Br J Urol. 1991;67:385-388. 4. Munks DG, Alli MO, Abdel Goad EH. Optical urethrotomy under local anaesthesia is a feasible option in urethral stricture disease. Trop Doct. 2010;40:31-32. 5. Ye G, Rong-gui Z. Optical urethrotomy for anterior urethral stricture under a new local anesthesia: intracorpus spongiosum anesthesia. Urology. 2002;60:245-247. 6. Ye G, Shan-Hong Y, Xiang-Wei W, et al. Use of a new local anesthesia-intracorpus spongiosum anesthesia-in procedures on anterior urethra. Int J Urol. 2005;12:365-368. 7. Ather MH, Zehri AA, Soomro K, et al. The safety and efficacy of optical urethrotomy using a spongiosum block with sedation: a comparative nonrandomized study. J Urol. 2009;181:2134-2138. 8. Kumar S, Prasad S, Parmar K, et al. A prospective randomized controlled trial comparing combined spongiosum block and intraurethral lignocaine with intraurethral lignocaine alone in optical internal urethrotomy for stricture urethra. J Endourol. 2012;26: 1049-1052. 9. Chilton CP, Shah PJR, Fowler CG, et al. The impact of optical urethrotomy on the management of urethral strictures. Br J Urol. 1983;55:705-710. 10. Gaches CGC, Ashken MH, Dunn M, et al. The role of selective internal urethrotomy in the management of urethral stricture: a multicenter evaluation. Br J Urol. 1979;51:579-583. 11. Steencamp JW, Heyns CF, DeKock MI. Internal urethrotomy versus dilatation as treatment for male urethral strictures. A prospective randomized comparison. J Urol. 1997;157:98-100. 12. Santucci RA, Eisenberg L. Urethrotomy has a much lower success rate than previously reported. J Urol. 2010;183:1859-1862. 13. Bullock TL, Brandes SB. Adult anterior urethral strictures: a national practice patterns survey of broad certified urologists in the United States. J Urol. 2007;177:685-690. 14. Al-Hunayan A, Al-Awadi K, Al-Khayyat A, Abdulhalim H. A pilot study of transperineal urethrosphincteric block for visual internal urethrotomy in patients with anterior urethral strictures. J Endourol. 2008;22:1017-1020.
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