Abstract
Objective:
Robot-assisted laparoscopic prostatectomy (RALP) with suprapubic tube (SPT), compared to urethral catheter (UC) drainage, has been proposed to improve patient comfort and recovery. We sought to compare short-term outcomes for pain and morbidity after RALP with SPT vs UC drainage.
Methods:
Between August 2012 and 2014, 159 men underwent a RALP and prospectively completed a questionnaire addressing postoperative pain and satisfaction. Group 1 (n = 94) underwent a RALP by one surgeon who placed a UC and removed it between postoperative day (POD) 7 and 10. Group 2 (n = 65) underwent a RALP by a different surgeon who placed an SPT and UC. On POD 1, the UC was removed. On POD 9, the SPT was capped and removed on POD 11 if the patient was voiding adequately. Preoperative and intraoperative data, complications, questionnaires, and patient-reported morbidity, including unplanned telephone calls and emergency department (ED) visits, were compared between groups.
Results:
Patient characteristics were similar between groups. One week after surgery, the penile pain score was statistically significantly lower in Group 2 compared to Group 1 (56.9% and 79.8%, respectively, reported minimal-to-moderate pain, p = 0.003). Bladder spasms and overall pain were not significantly higher for Group 1 compared to Group 2 (p > 0.05). When asked “How big a problem has your urine storage device been?,” 20.2% of patients in Group 1 reported it as a “moderate-to-big” problem compared to 10.8% in Group 2 (p > 0.05). The number of catheter-related unplanned telephone encounters did not differ between the two groups (p = 0.7), however, although not statistically significant, 4.6% of patients in Group 2 presented to the ED with catheter-related issues (p = 0.07).
Conclusion:
SPT after RALP was associated with less penile pain compared to UC drainage, and modestly better patient satisfaction. There were no significant differences in bladder spasms, overall pain, and patient-reported morbidity between groups.
Introduction
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UC drainage is traditionally utilized at the time of RALP not only for bladder drainage but also to bridge the urethrovesical anastomosis in an effort to prevent an anastomotic stricture. However, UC-associated discomfort, specifically metal irritation and penile pain are common postoperative complaints expressed by the patient. 3 –6 The use of a percutaneous suprapubic tube (SPT) has been proposed as an alternative to a UC for postoperative drainage after RALP. 7 –10 It has been shown to provide bladder drainage that is comparable to a UC with potentially less penile pain and irritation. An early description of patient tolerance of an SPT after RALP by Krane et al. demonstrated the feasibility of using a 14F SPT in place of a UC. They reported significantly less discomfort and no anastomotic strictures over a 7-month follow-up interval. 7 Although several reports of SPT drainage following RALP have shown feasibility and less patient discomfort, detailed aspects such as bladder spasms, penile pain, functional issues with the urinary storage devices, and overall pain have not been specifically evaluated or quantified. As well, patient-reported morbidity by way of unplanned postoperative encounters has never been published in the literature. In this study, we sought to focus on short-term quality-of-life outcomes, including overall pain, bladder spasms, penile pain, and functional issues, with the urinary storage device after RALP, with SPT vs UC drainage, and compare rates of unplanned telephone encounters, emergency department (ED) visits, and hospital admissions between the two groups.
Methods
After obtaining institutional review board approval, we reviewed and analyzed clinical data on 159 men who underwent RALP between August 2012 and August 2014 by one of two similarly experienced minimally invasive robotic surgeons. Group 1 (n = 94) underwent RALP by a single surgeon who placed a UC at the time of urethrovesical anastomosis and removed it between postoperative day (POD) 7 and 10. Group 2 (n = 65) underwent RALP by a different single surgeon who intraoperatively placed a percutaneous SPT in addition to the UC. On POD 1, the UC was removed and the SPT was left to drainage. On POD 9 to 10, the SPT was capped and removed 1 or 2 days later in the clinic if the patient was voiding adequately. Both surgeons preserved the bladder neck when technically feasible, performed a single-layered urethrovesical anastomosis, and did not perform a Rocco stitch reconstruction. All patients were discharged with a prescription for routine narcotic analgesics and a stool softener. All patients underwent extensive preoperative and postoperative counseling by the same surgeon and received printed instructions, developed at our institution, with a detailed description of the perioperative course, the procedure, and postoperative expectations.
UC placement technique
Following a one-layer running urethrovesical anastomosis with a 2-0 monofilament suture, the final 16F UC was placed and the balloon was filled to 10 mL of sterile water. Then, 300 mL of physiologic saline was instilled in the bladder through the UC to inspect for possible urine leak.
SPT placement technique
Following a one-layer running urethrovesical anastomosis with a 3-0 barbed suture (V-Loc™; Covidien, New Haven, CT), 300 mL of physiologic saline was instilled in the bladder through the UC to inspect for possible urine leak and to distend the bladder for identification of the optimal insertion site for the SPT.
The midline SPT placement site was identified by measuring a 2-cm distance cephalad to the pubic symphysis. Application of pressure by the bedside assistant over the potential placement site aided in the alignment of the anterior abdominal wall incision site with the optimal bladder insertion site. A 1-cm incision was made in the skin overlying the insertion sight and a spiked introducer (Lawrence Supra-Foley Introducer®; Utah Medical Products, Inc., Midvale, UT) was placed through the anterior abdominal wall under direct vision and then advanced into the bladder with the assistance of the console surgeon pushing up on the distended bladder. The trocar was removed, and through the sheath, a 16F catheter was inserted into the bladder and the balloon inflated with 10 mL of sterile water. The catheter was then secured to the skin using a 3-0 nylon suture, and a 3-0 barbed suture (V-Loc; Covidien, Mansfield, MA) was placed in purse-string fashion around the SPT securing the bladder to the anterior abdominal wall.
Questionnaire
Before discharge after RALP, patients in each group were given a questionnaire and instructed to self-administer it at home on POD 7. Questionnaires were distributed by a member of the surgical team other than the treating surgeon. Patients were not made aware that questionnaires were part of a comparative study nor were references made to the alternative drainage method. At this time point, either the UC (Group 1) or SPT (Group 2) was still in place. They were then asked to either mail the questionnaire back to the clinic in a postage-paid envelop or return it on a postoperative clinic visit. The questionnaire contained four items that were either taken directly from or modified from an item on the Expanded Prostate Cancer Index Composite (EPIC, Madison, WI) comprehensive instrument to evaluate patient symptoms after prostate cancer treatment (Appendix 1). 11
Telephone encounters and ED visits
We reviewed our electronic medical record (EMR) (EPIC) to identify all telephone, unscheduled office visits, ED visits, or hospital admissions after RALP. Phone calls were handled by the clinic nurse during business hours and by the resident and faculty on call after hours. We reviewed these encounters and categorized the reason for the unplanned encounter and identified the median/or mean time to encounter for each category. Catheter-related encounters were identified upon review of patients who had urinary drainage device in place at the time of the telephone call; encounters taking place after the drainage device had been removed were classified as catheter unrelated.
Statistical analysis
Statistical analysis was performed using the JMP statistical package (JMP® version 11). Demographic, intraoperative, and postoperative data were obtained for all patients. Questionnaire responses were compared between the two groups. Continuous variables were evaluated with the Mann–Whitney U test. Categorical variables were compared using Fisher's exact test. Statistical significance was predefined as p < 0.05.
Results
Patient demographics, preoperative and intraoperative data, and complications are shown in Table 1. There were no significant differences between Groups 1 and 2 for mean age, body mass index, American Society of Anesthesiologists (ASA) score, preoperative prostate-specific antigen, use of nerve-sparing techniques, estimated blood loss (EBL), and prostate volume. Both groups had a median postoperative Gleason sum of 7. More patients in Group 1 had a higher pathologic T stage than in Group 2 (p < 0.02). Median operative time for Group 1 was significantly shorter than for Group 2 (177 minutes vs 230 minutes, p < 0.0001). This was not due to the SPT placement alone, which took ∼5 to 10 minutes. After clamping the SPT, two patients in Group 2 reported pain associated with voiding. A voiding cystourethrogram was performed immediately on both patients, demonstrating a small urine leak in both. They were both managed conservatively (Clavien grade 1) with placement of a UC for 7 days in addition to their SPT. All patients had a minimum 3 months of follow-up. All patients who were subsequently followed by their referring physician were advised that in the case of any complications, including difficulty voiding (i.e., anastomotic stricture), to contact our center for further treatment and follow-up. To date, no patient in either group has required a cystoscopy or further intervention for an anastomotic stricture.
Parameters are reported as medians with interquartile ranges in parentheses unless otherwise specified. Ten patients in the urethral catheter cohort and 34 patients in the SPT cohort had fewer than 6 months of follow-up at our institution after prostatectomy. Of these, 3 and 28, respectively, continued to follow up with their outside urologists.
Missing data as follows: four patients with missing ASA; five patients with missing Gleason sum; three patients with missing T stage.
Differences in operative time not due to SPT placement alone.
ASA = American Society of Anesthesiologists; EBL = estimated blood loss; PSA = prostate-specific antigen; SPT = suprapubic tube.
One week after surgery, 36.9% of patients in the SPT group reported no penile pain compared to 15.9% of patients in the UC group (p = 0.005) (Table 2). Bladder spasms and overall pain were not significantly different between groups. A significantly greater proportion of patients who received SPT reported that their urinary drainage device was a “very small-to-small problem” (80.0% vs 60.6%, p = 0.02); in contrast, a nonsignificantly greater proportion of patients with UC reported a “moderate-to-big problem” (20.2% vs 10.8%, p = 0.1).
Although not statistically significant, there was a difference in the number of postoperative catheter-related ED visits between the two groups (Table 3). Three patients (4.6%) in Group 2 presented to the ED with catheter-related issues compared to none in Group 1. These patients presented to the ED at POD 3 or 4, all with SPT blockage by a small clot. All patients were discharged from the ED on the same day with no sequelae. A similar proportion of patients in both cohorts telephoned our clinic, resulting in 168 and 120 encounters, respectively, for Group 1 and Group 2. Of these telephone calls, the proportions of catheter-related calls did not differ substantially between patients who had UC or SPT (13.1% vs 15.0%, p = 0.7). Fifty percent of patients called more than once. The median time from surgery to the first telephone call was 4 days for catheter-related calls and 10 days for catheter-unrelated calls, irrespective of drainage method. Patients in Group 1 and Group 2 had a median time to catheter-related call of 3 and 6.5 days, respectively. Fever and urinary complaints unrelated temporally to the urinary drainage method, that is, presenting after removal of the catheter, however, were significantly more common in patients with Group 1 (3.6% and 8.3%, p = 0.04 and 0.005) (Table 3). There were no hospital readmissions in either group while the UC or SPT was in place.
Variables reported as medians with interquartile ranges in parentheses unless otherwise specified.
“Miscellaneous” calls refer to condition update, questions regarding follow-up, etc.
ED = emergency department; EMR = electronic medical record.
Discussion
Conventional doctrine states that a UC is necessary following RALP, to not only drain the bladder but also to bridge the anastomotic line, thus preventing a urethrovesical anastomotic stricture. As a UC has been felt to be crucial for success following RALP, its associated morbidity is accepted as an unavoidable component of the procedure. Recently, an SPT has been proposed for bladder drainage after RALP and has been shown to provide effective bladder drainage and reduced patient morbidity without increasing the risk of complications, such as urethrovesical anastomotic strictures. We specifically focused on short-term quality-of-life outcomes and patient-reported morbidity after RALP with SPT vs UC drainage. We found that penile pain was significantly less with an SPT compared to a UC, but found no significant difference in bladder spasms and overall pain between groups. While the UC and SPT were in place, patients' catheter-related telephone encounters were similar between groups. Interestingly, there were a significant number of unplanned encounters in both groups. This may suggest a gap in communication between the surgical team and patients. Three patients in the SPT group did present to the ED with catheter-related issues; however, these issues were minor and patients were discharged the same day with a close follow-up and did not experience any long-term complications. Our results add to the recent literature that has examined the feasibility and outcomes of the SPT as an alternative for bladder drainage after RALP. Tewari et al. first described suprapubic drainage following RALP in 10 patients, using a custom-made SPT with a urethral extension that bridged the urethrovesical anastomosis. 10 The authors were able to demonstrate the feasibility of the SPT for bladder drainage, and in the process showed that their technique resulted in significantly less penile pain with ambulation than patients with a UC. Subsequently, Krane et al. evaluated short-term outcomes of 202 patients who underwent RALP with a percutaneous SPT for postoperative drainage. 7 They found that those with the SPT had a significantly decreased catheter-related discomfort on POD 2 and 6 compared to 50 control patients who underwent the procedure with a traditional UC (p < 0.001). Furthermore, after 7 months of follow-up, none of these patients were diagnosed with urethral strictures. 7 However, 10 patients did require urethral catheterization for SPT dislodgement (n = 5) or urinary retention (n = 5).
Long-term safety and functional outcomes of SPT drainage were evaluated in a study by Sammon et al., who followed 339 patients who underwent RALP with SPT drainage. 8 At a median follow-up of 11.5 months, 86.4% of patients had total urinary control and 25.4% reported that they never wore a pad; however, 4.7% (16 patients) required perioperative UC placement for hematuria (2 patients), SPT malfunction (4 patients), and urinary retention (3 patients), and 7 patients require prolonged catheterization for urine leak. Only one patient was diagnosed with a bladder neck contracture, 2 years postoperatively. In our cohort, two patients had a small urine leak in Group 2. They were managed conservatively with the placement of a UC for 7 days in addition to their SPT. There was no statistically significant difference between Groups 1 and 2 in terms of urine leak (0% vs 3%, respectively).
Most recently, a prospective randomized trial was performed to evaluate whether SPT drainage with early removal of the UC could improve postoperative pain compared to UC drainage alone in patients undergoing RALP. The authors randomized 29 patients to the UC group and 29 patients to the SPT and UC group. Patients with the UC alone had the catheter removed on POD 7, while those with the SPT and UC had the UC removed on POD 1. They demonstrated no significant difference in postoperative pain scores assessed on POD 0, 1, and 7. 12 The authors indicated that 79% of men responded that the UC was the most bothersome.
Our results confirm that the SPT is well tolerated by patients and associated with less penile pain compared to the UC. In contrast to Krane et al., we did not notice a significant decrease in bladder spasms between groups. 7 We also confirmed that SPT drainage did not increase the risk of postoperative complications such as anastomotic stricture. Finally, studying a new metric, we have shown that patient-reported morbidity by way of telephone encounters has not differed between patients with an SPT or a UC.
We acknowledge that particular concerns may exist with the use of SPT drainage after RALP. One is that the SPT traversing the bladder wall may exacerbate hematuria, and its smaller lumen may be insufficient to adequately drain or manually irrigate out blot clots, which may increase in the presence of bladder spasms. In our study, one patient in the SPT group developed significant hematuria with blood clots, and this was successfully resolved with conservative management. Second, a UC bridges the anastomotic line, and in doing so, this is thought to help prevent a urethrovesical anastomotic stricture. Absence of a UC may lead to a greater risk of stricture, yet the evidence in the literature regarding this is lacking. In our experience, no patients in either group required cystoscopy or further intervention for anastomotic strictures during a follow-up. However, in the SPT group, the mean follow-up time was too short to draw meaningful conclusions on SPT usage and the risk of anastomotic stricture. Another concern is that patients with an SPT may require catheter reinsertion at a higher rate than patients with the UC. However, Tiguert and colleagues performed a retrospective review of 342 consecutive patients undergoing radical retropubic prostatectomy to compare early (POD 4) vs late (>4 days) catheter removal. 13 Patients with early catheter removal had a 3% rate of urinary retention, which was not significantly different compared with the late catheter removal group (2%). One advantage of the SPT, not clearly described in the literature, but part of our SPT protocol, is the ability to perform a voiding trial without removal of the drainage catheter. In cases with a UC, patients who develop urinary retention require catheter replacement across a fresh anastomosis. In those with an SPT, the concern for urinary retention is eliminated as it is very simple to perform a cap trial and SPT removal when clinically indicated.
We acknowledge that there are certain limitations to this study. RALP was performed by two different surgeons and the technique for bladder drainage was unique to each. As such, unaccounted for technical factors may have influenced our results. Second, we used a questionnaire containing items, which were either taken directly from or modified from the EPIC comprehensive instrument, to evaluate patient symptoms after prostate cancer treatment, however, we did not use validated questionnaires to assess patient quality-of-life or satisfaction levels at different time points after RALP. With regards to describing patient-reported morbidity by way of telephone/email encounters and ED visits, preoperative and postoperative patient anxiety were not evaluated in an objective fashion. Also, patients who were followed by their local urologist after 3 months may not have reconsulted our center if issues such as anastomotic stricture occurred. Therefore, the possibility of an unknown anastomotic stricture in this cohort exists. Finally, our total sample size is not large and our sample sizes are unbalanced, which may limit our conclusions; however, our numbers are consistent with the current body of literature on the subject.
Conclusions
SPT bladder drainage after RALP is feasible and is associated with less penile pain and modestly better patient satisfaction compared to the use of UC drainage. SPT drainage can be performed with minimal complications.
Footnotes
Author Disclosure Statement
No competing financial interests exist.
Abbreviations Used
Appendix 1. 1 Week After Surgery
Name: __________
Date: ___________
References
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