Delayed healing is common in in‐situ urethroplasty patients after artificial sphincter cuff erosion

Abstract

Introduction: Urethral erosion is a known complication of artificial urinary sphincter (AUS) surgery. We performed an in‐situ urethroplasty (ISU) to reduce the healing time and time to reimplantation of the AUS. We sought to assess urethral integrity one month after ISU and to identify factors associated with delayed healing in our high‐volume tertiary referral center experience.

Methods: A retrospective review of our AUS database from 2009 to 2023 was conducted to identify all ISU cases. Patients were stratified as healed or non‐healed based on the absence of extravasation on voiding cystourethrogram (VCUG) obtained 4 weeks postoperatively. Background characteristics were evaluated including age, body mass index, diabetes, hypogonadism and smoking history. Operative variables included degree of erosion, location of defect, and the number of stitches required for repair.

Results: Among 98 patients undergoing an ISU, 61 underwent VCUG at one month. Of these, 34.4% (21/61) had evidence of delayed healing on VCUG requiring prolonged catheterization. Although a higher average number of repair sutures were used in ISU, this was not significant (p = 0.381). The most common complication in both groups was urinary tract infection (UTI). Non‐healed patients had a higher rate of UTI, without significant predilection towards fistula, stricture or diverticulum. No other patient or operative characteristic was significantly different between groups.

Conclusion: Despite an aggressive approach to management via ISU, many patients still require prolonged catheterization after AUS erosion to ensure complete healing of the defect.

Keywords

artificial urinary sphincter / clinical pathway / complication / erosion / in‐situ urethroplasty (ISU)

1 INTRODUCTION

Urethral cuff erosion (UCE) is a known complication of artificial urinary sphincter (AUS) implantation and occurs in 2%–15% cases, depending on reports[1]. Although there are various strategies for managing erosion, no consistent treatment algorithm exists. Traditionally, UCE has been managed by device removal and simple placement of a Foley catheter across the defect, with or without concomitant suprapubic catheter placement[2]. However, stricture formation and delayed healing are common. In turn, the management of the defect without primary closure of the urethra or capsule may delay device replacement and may predispose the patient to further erosions[3].

In an effort to promote healing and reduce secondary complications such as fistula, diverticulum and stricture, we previously proposed the concept of in‐situ urethroplasty (ISU), whereby the urethral defect is closed by re‐approximating the capsule at the time of AUS removal[2,4]. Traditionally in our practice the protocol after ISU has been to obtain a voiding cystourethrogram (VCUG) 4 weeks post‐operatively to confirm healing with repeat imaging 2–4 weeks later if extravasation is present. Given an anecdotal observation that many patients had extravasation seen at the 4‐week timepoint, we sought to evaluate this objectively. We aimed to assess the incidence of delayed healing one month after ISU and to identify factors associated with delayed healing in our high‐volume tertiary referral center experience.

2 METHODS

A retrospective review of our three‐surgeon AUS database from 2009 to 2023 was completed in order to identify patients with a history of erosion who had been managed with ISU. ISU was performed as previously described[4]. Patients were excluded if their follow‐up care was obtained elsewhere, or if VCUG images were not available for review. Patients were considered “healed” if there was no extravasation at the first VCUG. Patients were then stratified into two groups based on the status of the VCUG results: a healed group and a non‐healed group.

The two groups were further analyzed using demographic characteristics including age, body mass index (BMI), diabetes, hypogonadism, and smoking history (measured in pack‐years). Operative variables considered included the degree of erosion (DOE), the location of the defect, and the number of stitches required for repair. Chi‐square and Fisher's Exact tests were used to compare data of the categorized groups for a minimum of 30 BMI, hypogonadism (testosterone < 250 ng/mL), diabetes, a smoking history exceeding 10 pack‐years, the location of erosion, and a minimum of 180 degrees of erosion. The Shapiro‐Wilk test was utilized to assess normality for continuous variables, and Student's T‐test and Mann–Whitney U test were performed to compare groups as appropriate. Statistical tests were performed using the SciPy Library (Version 1.11.4).

3 RESULTS

Among 98 patients undergoing ISU following urethral cuff erosion, 61 had documented VCUG at the one‐month follow‐up and were included for analysis. Of these, 40/61 (65.6%) had no extravasation on one‐month VCUG and were classified as healed, while 21/61 (34.4%) had extravasation and were classified as non‐healed. Mean age in the healed and non‐healed groups was 75.21 (± 6.36) and 75.93 (± 9.57) years, respectively (p = 0.727). While a greater percentage of the non‐healed patients had a smoking history of more than 10 pack‐years, this was not significant (p = 0.171). A total out of 23 of 40 in the healed group and 13 out of 21 in the non‐healed group had a history of radiation, which was not statistically significant (p = 0.740). All other differences in patient background characteristics including BMI, the history of urethroplasty, diabetes, and hypogonadism, were similar.

With regards to erosion characteristics, 37 healed patients and 17 non‐healed patients had location of erosion information available. 21.6% (8/37) of healed patients and 17.6% (3/17) of non‐healed patients had a dorsal erosion (p = 1, Table 1). 35 patients in the healed group and 19 patients in the non‐healed group had degree of erosion information available. 54.3% (19/35) of healed patients and 57.9% (11/19) of non‐healed patients had urethral erosions greater than or equal to 180 degrees (p = 0.635). While the median number of sutures required for repair was greater in the non‐healed patients (healed 5 vs. non‐healed 7), this was not significant (p = 0.381).

Median follow‐up was 16.3 months (IQR: 26.4) in the healed cohort and 19.5 months (IQR: 35.4) in the non‐healed cohort (p = 0.643). Time to VCUG was similar for both the healed cohort and non‐healed cohort (median 30.0, IQR 7.25 vs. median 31.5, IQR 18.75, p = 0.261). Of the non‐healed patients, 7/21 (33.3%) required 3 or more VCUGs with prolonged catheterization before healing was achieved. 16 patients in the non‐healed group and 34 patients in the healed group had at least 180‐day follow‐up. While complications were common in both groups, 180‐day complications were significantly more likely in the non‐healed group (10/16, 62.5%) than in the healed group (11/34, 32.4%, p = 0.044).

The most common complication in each group was urinary tract infection, occurring in 9/34 of the healed and 5/16 of the non‐healed patients. Urethrocutaneous fistulas developed in 3/16 of the non‐healed group; no patients in the healed group developed a urethrocutaneous fistula.

4 DISCUSSION

Urethral cuff erosion is a known complication after AUS implantation. However, there is currently no consensus or standard treatment algorithm on management of this complication. In an effort to mitigate the detrimental effects of stricture and fistula formation, we utilize ISU for cuff erosion treatment[4]. We have previously found that performing ISU is associated with not only fewer interim procedures before undergoing device replacement, but also a higher likelihood of undergoing secondary AUS replacement[4]. However, the appropriate duration of catheter diversion after ISU has not been studied. While tempting to reduce catheter time to 2–4 weeks, our data shows that a full third of patients required catheter for a longer duration. Therefore, we now advocate for a longer duration of catheter diversion such as 6 weeks following ISU. This is, to our knowledge, the first study to assess optimal catheter duration after management of cuff erosion. Our approach centers on aggressive repair and careful radiographic verification of healing after AUS cuff erosions appears to virtually eliminate complications such as stricture and fistula.

While many patients are disappointed with this prolonged catheter dwell time, we find that tempering patient expectations at the time that erosion is diagnosed supports an improved patient–surgeon relationship. This concept is not new concept within urology; others have shown that pre‐operative counseling regarding expectations during recovery from Holmium Laser Enucleation of the Prostate (HoLEP) is crucial to navigating the sometimes challenging postoperative course[5]. Even outside of urology research area, others have demonstrated that patients who received more thorough counseling and education pre‐operatively had a lower incidence of complications[6]. Extrapolating this to our data, being forthcoming with patients regarding the anticipated length of catheterization and surgical course may improve satisfaction and lower complications.

4.1 Alternatives to in‐situ urethroplasty

Historically, cuff erosion was managed with device explant and simple urethral catheter diversion—with or without suprapubic catheter placement for a number of weeks. This remains the method of choice for many reconstructive urologists[4,7]. One concern with this option is the risk of urethral stricture formation which might lead to delayed reimplantation of the AUS. Rates of stricture formation following urethral catheter diversion only range from 8.3% to 85%, depending on the study[4,7]. While our group found that stricture rates were significantly lower following ISU versus simple catheter diversion, others have not found that to be the case[4,8,9]. Regardless, stricture formation is more likely when there is a higher degree of erosion, and also appears to be more likely after pelvic radiation[8–10]. And while such strictures may be managed with urethroplasty and subsequent device reimplantation, outcomes are far worse than with the original placement[3,11]. The overall fistula rate of 3/61 (4.9%) in our data is low and important as fistula presence prevents reimplantation of AUS.

Alternatively, more extensive debridement and urethral mobilization may be pursued and formal urethroplasty performed[8,9]. Compared to ISU, which involves simple closure of the capsule around the sphincter and urethra, formal urethroplasty involves mobilization of the proximal and distal urethral ends, debridement of any nonviable tissue, and anastomosis after spatulation is performed[8]. Unsurprisingly, the decision of surgical approach depends on patient and erosion characteristics as well as surgeon comfort; in two studies comparing all three approaches (simple catheter diversion, ISU, formal urethroplasty) patients were more likely to undergo catheter diversion for small erosions, while formal urethroplasty was more likely in cases of more extensive erosion[8,9]. Regardless of the approach chosen, there is no consensus on optimal catheter duration, with some advocating for as little as two weeks of catheter drainage. Likewise, some—like our group—perform VCUG in all cases, while others remove the catheter without imaging[2,4,8].

4.2 Risk factors for delayed healing

Among the captured data points, no risk factors were identified for delayed healing after ISU. Smoking status and diabetes—which have been found to impact healing in other surgical situations—were not significant in our analysis[12,13]. In the general urethroplasty literature, age, smoking status, and previous procedures have been found to be associated with delayed healing or stricture recurrence[12–14]. A history of prior pelvic radiation and urethroplasty has been found to place patients at increased risk of cuff erosion[15,16]. Interestingly, we did not find that these were associated with delayed healing after ISU.

4.3 Monetary considerations

Early imaging in this high‐risk population may not be necessary and costly to the health care system. Standard VCUG costs $271 with an interpretation not including cost associated with return visits and travel[17]. We propose that given the average time to heal by VCUG in the ISU population, obtaining the first VCUG at 6 weeks instead of the 4‐week protocol may be more advantageous, thus reducing the need for repeat studies.

4.4 Limitations

This is, to our knowledge, the first study to assess optimal catheter duration after the management of cuff erosion. Our approach, centered on aggressive repair and careful radiographic verification of healing after AUS cuff erosions, appears to virtually eliminate complications such as stricture and fistula. Future, multicenter studies looking at catheter duration after all three approaches—ISU, simple urethral catheter diversion, and formal urethroplasty—would be ideal. More importantly, downstream studies comparing ultimate AUS outcomes after ISU versus alternative erosion management are needed.

This study is limited by its small sample size, in part because a third of patients were excluded due to lack of follow‐up imaging. Given our status as a tertiary care center, many patients followed up with an outside urologist closer to home. This small sample size may also account for certain factors such as BMI and pelvic radiation—which have been well‐documented risk factors for poor wound healing—being not significantly different in our study[18]. We also did not have a set algorithm in place regarding when subsequent VCUGs should be performed. Thus, some patients may have gone longer intervals prior to second or third VCUGs. Use of a standardized protocol in a prospective fashion would have allowed us to draw more conclusions regarding optimal catheter duration.

5 CONCLUSION

Despite an aggressive approach to AUS erosion management using ISU, delayed healing is common, requiring prolonged catheter drainage for more than one month in a third of patients. Preemptively planning for prolonged catheter drainage and postponing the initial VCUG to 6 weeks post‐operation may reduce the economic burden on the patient, improve health‐related quality of life, and decrease post‐operative clinic burden. Additional studies are warranted to better define optimal catheter management after ISU.

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2024 The Author(s). UroPrecision published by John Wiley & Sons Australia, Ltd on behalf of Higher Education Press.