Office-Based Endoscopic Urological Procedures Under Local Anesthesia: Prospective Evaluation of Feasibility,Pain,and Patient Preference

Introduction

Advancements in technology and instruments, improved endoscopic skills, inefficiencies associated with facility-based surgeries, and increased reimbursement for office-based surgery have driven more advanced endoscopic procedures into the office setting in recent years. The office setting provides multiple potential advantages to both patients and physicians, including time and cost savings. Moreover, elderly patients could highly benefit from the office setting due to the avoidance of general anesthesia. General anesthesia, even for noninvasive and minor urologic procedures, may adversely affect functional status in the elderly and increase mortality rate. ¹

Fear of inducing pain and fear of experiencing pain frequently deter physicians and patients from office-based surgery under topical anesthesia. Therefore, while procedures such as cystoscopies and stent removals are already performed routinely in the office with topical anesthesia, the majority of more advanced endourological procedures are still performed under sedation or short-term anesthesia either in the office or in the operating room (OR). ^2,3

Previous studies investigating and comparing the safety and efficacy of some procedures in the clinic to those in the OR have indicated excellent outcomes. However, most published studies have not evaluated advanced procedures and have rarely assessed patient preference. ^{4 –7}

In our office, several endoscopic urological procedures typically done in other settings, including ureteral stent placement and exchange, ureteroscopy with biopsy and fulguration of tumors, and ureteral catheterization for retrograde ureteropyelography or upper tract instillation of anti-cancer agents, have been routinely performed for over 25 years using only topical anesthesia. The purpose of this study was to assess the feasibility, safety, pain tolerance, patient preference, and cost-effectiveness of office endourological procedures.

Materials and Methods

Institutional Review Board (IRB # 14-00879) approval for data collection and evaluation of all patients undergoing office-based endoscopic urological procedures was obtained. We assessed patients’ subjective pain level in real time, using a pain visual analog scale (VAS), and at the conclusion of the procedure queried patient preference for having the procedure done in the office setting under topical anesthesia vs in a surgery center under general anesthesia.

Consecutive patients undergoing office-based endoscopic procedures, including ureteral stent placement for obstruction, ureteral stent exchange, ureteroscopy with laser lithotripsy, ureteroscopy with tumor ablation, laser ablation of multifocal bladder tumors, laser lithotripsy of bladder stones, nephrostomy tube exchange, and ureteral catheterization for chemotherapy administration or retrograde ureteropyelography, were included after obtaining informed consent. Indications for the performance of the procedure in the office setting include patient convenience, patient comorbidities, and patient preference. All procedures were performed by a single surgeon (M.G.) in an office suite equipped with a fluoroscopic C-arm. The endoscopes used for all procedures were a flexible video-cystoscope (Olympus, Southborough, MA, USA) and a flexible fiberoptic ureteroscope (FLEX-X², Karl Storz & Co. KG, Tuttlinger, Germany). A Thulium Fiber Laser (Fiber Dust™, Quanta Systems, Samarate, Italy, distributed by Cook Endourological Inc., Bloomington, Indiana) was used when performing laser lithotripsy and laser tumor ablation. When performing ureteroscopies, we perform a no-touch technique where we directly place the ureteroscope into the ureter under direct vision. If the ureter is difficult to access or narrow, a guidewire is placed a short distance up the ureter through the ureteroscope, and then the scope is advanced over the wire. Once in the distal ureter, the wire is removed and the ureteroscope is advanced up the ureter under direct vision to make sure no tumors or stones are missed. A complete mapping of the collecting system is done, and tumors or stones are treated. Gravity irrigation is used throughout with a saline bag. If a patient feels flank pressure, fluid is aspirated from the collecting system with a 10-cc syringe until the system collapses completely before resuming gravity irrigation. No pressurized irrigation is used.

Prior to instrument insertion, all patients except for the nephrostomy tube exchanges receive intraurethral 2% lidocaine jelly for topical anesthesia and a periprocedural antibiotic. Patients undergoing nephrostomy tubes exchange via the flank or an ileal conduit receive only periprocedural antibiotic. Procedure time started with genitalia prepping and ended when all instruments were removed. Patients were discharged right after the procedure, and no observation was needed since no general anesthesia or parenteral narcotic medications were administered. We do not have a recovery room. They were asked to stay on the procedure table as long as they needed after the completion of the procedure.

Demographic data (age, sex, and Charlson Comorbidity Index [CCI]) were recorded. At the end of each procedure, every patient was asked to evaluate pain on a 10-point VAS and assessment of their experience and whether they preferred the office with topical anesthetic vs the OR with general anesthesia.

All procedure-related calls to the office, emergency department (ED) visits, secondary procedures, and hospital admissions related to the procedure were evaluated. Complications were recorded. Facility and anesthesia costs for identical procedures done in an OR setting were determined to better evaluate the cost-effectiveness and were compared with costs in the office setting.

Results

A total of 80 consecutively performed procedures were included: 11 bladder procedures, 9 ureteroscopic procedures, and 60 stent and nephrostomy procedures (Table 1).

Bladder procedures included nine extensive laser ablations of multifocal tumors and two laser cystolithalopaxies with a median age of 78 years old and a median CCI of 5. Four out of 11 patients (36.3%) underwent the procedure for the first time with a mean procedure time of 27.5 minutes. Of the nine ureteroscopy procedures during the time period of the study, eight were for a history of upper tract urothelial carcinoma. Several of these patients have been followed in the office for over 10 years with periodic ureteroscopy to find and treat recurrences. In two of the eight, tumors were found and ablated using a Thulium Fiber Laser (TFL) laser. One additional ureteroscopy patient underwent ureteroscopy with laser lithotripsy. This patient was not pre-stented, and he had a mid-to distal-ureter stone and severe flank pain but was deathly afraid of anesthesia, so we offered office ureteroscopy and laser lithotripsy under local anesthesia. The median group age was 68 years old with a median group CCI of 4. Four out of nine patients (44.4%) experienced the procedure for the first time with a mean procedure time of 21.9 minutes. Stent and nephrostomy procedures included 50 stent exchanges and 10 stent placements for obstructing stones and severe pain with a median age of 68 years old and a median CCI of 5. All 10 patients underwent ureteral stent placement for the first time, and the overall group mean operative time was 11.3 minutes.

Table 2 shows mean VAS scores after the procedures and the location preference. For the bladder procedures, including two laser cystolithalopaxy procedures and nine laser tumor ablations, the mean visual analog score was 2.4. When asking patients about their experience, patients stated they preferred laser ablation to electrocautery due to improved postoperative pain. Ureteroscopic procedures had a mean VAS score of 3.9. The mean VAS score for patients with ureteroscopies with tumor laser ablation was four, and the same patients expressed their preference for having their procedure performed in the office setting after the procedures. On the contrary, the mean VAS for ureteroscopy with laser lithotripsy was 6. Stent and nephrostomy procedures had a mean VAS score of 3.3. 100% of bladder procedure patients had a VAS score of 1 or 2 (Fig. 1). Bladder, stents, and nephrostomy procedure groups expressed unanimously an office-setting preference. The office setting was also preferred by a majority of patients undergoing ureteroscopic procedures (77.8%). There were 37 patients who experienced the procedure in the OR, and 100% of those patients preferred the office setting for their subsequent procedure.

OPEN IN VIEWER

FIG. 1.

Visual Analog Scores of Office Procedures.

Unplanned health care encounters, complications, and failures related to the procedures are listed in Table 3. A total of eight postprocedural phone calls and two ED visits occurred. There was one complication (urinary retention) and one failed stent placement. The reason for the failed stent placement was the inability to pass the guidewire past a very severely impacted ureteral stone, and this patient was the only one admitted after their procedure.

Office-based procedural costs were calculated by adding the cost of materials and supplies, including endoscopes: cost of personnel assisting in the procedure; and the cost of office space, which ranged from $300 to $1,105. OR costs for the same procedures by CPT code were obtained from our facility and included OR time, recovery room time, and materials and ranged between $5,709 and $7,114. Costs for anesthesia for the same procedures were obtained from the anesthesia department and were based on time (less than 1 hour procedure) and were $1,519 per case. Cost savings between OR and office settings ranged from $5,309 to $6,009.

Discussion

Office-based endoscopic procedures have been growing in the urological field. Multiple studies have investigated their safety and feasibility, also comparing them to an OR setting. However, prior studies looked at a limited group of procedures where sedation was used to better control patients’ pain. ^4,5,8 We aimed to provide a series of diverse endoscopic procedures performed in the office, using topical anesthesia only, focusing on patients’ perspectives about pain tolerance and choice of setting as primary outcomes and costs as a secondary outcome.

In our series, the majority of patients tolerated the endourological procedures very well with only local topical anesthesia and suffered minimal complications, with only one recorded complication in the cohort. In a prior study, Doersch et al. evaluated nitrous oxide as an anesthetic during office stent placements, finding no difference in the complication rate compared to the OR setting. ² However, nausea and vomiting represented the most common side effects in the office group, likely related to N₂O. In addition, some other less common side effects of N₂O include increased pulmonary artery pressure, possible endothelial dysfunction, and hypercoagulability, thus limiting its use in selected patients. ⁹ In a comparative study evaluating ureteral stenting in a hospital-based clinic vs the OR, Connelly et al. found stent placement in a hospital-based clinic setting after intramuscular injections of meperidine and promethazine for pain and nausea to be a safe alternative and more cost-effective with no differences in narcotic use and complications. ⁶ However, these procedures were not done in the office or under topical anesthesia only. It should also be noted that intramuscular injections of meperidine and promethazine for pain and nausea could have adverse effects that could be more severe in the elderly population. ¹⁰ In addition, the study did not distinguish between de novo stent placement and stent exchange and did not assess the patient experience. The costs calculated in this study were very high for the clinic setting, reporting the average cost of materials in the clinic at over $11,000. It is unclear why this would be the case, as our office costs were in the range of $300–$1,105.

Pain tolerance is a very important measurement when assessing office procedures. The mean VAS score in every procedure group was found to be less than 4 points: 2.4, 3.9, and 3.3 respectively, in bladder, ureteroscopic, and stent/nephrostomy cohorts, with no need for sedation or pain medication other than 2% lidocaine jelly right before the instrument insertion. For bladder procedures, including two cystolithalopaxy procedures and nine laser tumor ablations, the mean VAS was 2.4 When asking patients about their experience, patients stated they preferred laser ablation to electrocautery due to improved postoperative pain. For ureteroscopic procedures, the mean VAS score for patients with ureteroscopies with tumor laser ablation was four, and the same patients expressed their preference for having their procedure performed in the office setting after the procedures. Furthermore, the mean VAS for ureteroscopy with laser lithotripsy was 6. In our experience, there are two types of pain patients experience during ureteroscopy—flank pressure from increased intrarenal pressure (activation of renal capsule mechanoreceptors, usually mediated by A-delta fibers) and a burning type of pain from local activation of C-type fibers. The first type of pain is mitigated by using only gravity irrigation to prevent overdistention. We set the saline bag to hang at about 60 cm of H₂O. For cystoscopic procedures, we use minimal irrigation to prevent bladder distention. During ureteroscopy, we also use only gravity irrigation. Should flank pain occur, it is easily alleviated by aspirating fluid from the ureter or collecting system or by disconnecting the irrigation fluid and allowing fluid to passively egress from the working channel of the scope. To our surprise, we found that the second type of pain is significantly less using a laser compared to using electrocautery via a Bugbee electrode. Patients who had previously been treated for tumors in the bladder or the ureter were actually surprised by how much less discomfort they felt with the laser. In fact, some of these patients after this study who had office treatment with a Bugbee remarked they preferred the laser! What helps with pain, regardless of whether a Bugbee or laser is used, is reducing the energy settings. For Bugbee, we go down to 10 W. For the TFL laser, we are using 1 J and 1 Hz (1 W) or 1 J and 2 Hz (2 W) as our starting settings, and most patients feel virtually no discomfort with this setting.

To the best of our knowledge, there has been only one published series evaluating pain for outpatient urological procedures. ¹¹ These patients did receive parenteral analgesia for shockwave lithotripsy, ureteroscopic lithotripsy, cystoscopy, and ureteral stent placement. The study found SWL to have the highest VAS scores compared with endoscopic procedures. In addition, patients who had ureteroscopy laser lithotripsy, following an intramuscular injection of pethidine HCl 50 mg, had lower pain scores compared with the other endoscopic procedures. However, clinical outcomes and complications were not recorded in this study. ¹¹ Pain from our office-based procedures seemed to be well-tolerated as evidenced by low VAS scores, and the vast majority of patients preferred the office-based location to an OR, indicating a high relative level of patient satisfaction and showing the importance of careful patient selection. One exception was the patient who underwent ureteroscopy with laser lithotripsy. In retrospect, this was a very anxious patient and was not the best candidate for office-based surgery and was the only patient in our series that indicated he would have preferred having anesthesia; he also had the highest VAS score of all our patients. It is of deemed importance to carefully evaluate every single patient when offering a procedure in an office setting, considering both their anxiety and compliance.

We feel the office setting could become a possible alternative to the OR for many endourological procedures that are currently being done in ambulatory surgery centers (ASCs) or hospitals, which have inherent disadvantages. General anesthesia provided in the OR can impair elderly patients’ prognosis, exposing them to postoperative delirium risks and high mortality rates even in minor procedures. ^1,12 The cost-effectiveness of office setting procedures also represents an additional benefit. Both OR and anesthesia total costs, ranging between $5,709 and $7,114 according to different procedures in our institution, are substantially reduced in the office setting, with the costs of office procedures ranging from $300 to $1,105. The findings of our study lead to possibly a new standard for the safe and cost-effective conduct of advanced endoscopic urological procedures in the office. We feel as more urologists become facile with office-based surgery, many of the procedures currently being conducted in ASCs and hospital ORs could be shifted to the office, to the benefit of patients, surgeons, and the health care system in terms of morbidity, complications, safety, efficiency, and cost.

This study, and performance of office-based procedures in general, are not without limitations. Our goal was to demonstrate the feasibility and safety of performing several endourologic procedures in the office with only topical anesthesia. More data are needed to validate and ensure the generalizability of our findings. In addition, we carefully selected patients for office-based procedures. Patients had to be motivated to have their procedure performed in their office and have low anxiety levels related to the procedure. This data cannot be translated to the general population. Another main limitation in this study is the absence of a comparison group consisting of patients undergoing similar procedures in an OR under general anesthesia. Such a comparison would best be performed with patients who have had identical procedures performed in both settings, which in our cohort was very uncommon. There is a selection bias, since all the patients undergoing office procedures preferred the office setting; otherwise, they would not have been included in the series. We also acknowledge that for many urology practices worldwide there may be significant financial or equipment-based barriers to performing office-based surgery. Lasers, fluoroscopy equipment, and endoscopes generate high start-up costs for practices in which these pieces of capital are not readily available.

Conclusion

Office-based endoscopic urological procedures are safe and well tolerated when patients are carefully selected and motivated. Moreover, this cohort presents a small subset of patients from a larger cohort in which the senior author performed this technique. This highlights that the procedure is well-established and not limited to an initial small-scale trial. They provide several advantages, including the avoidance of general anesthesia in an elderly and sick population. They also allow the OR setting to be limited to more invasive procedures, easing surgeons’ schedules and the burden on our health care system. Comparative studies are needed to validate and ensure the generalizability of our findings.