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Perineal Urethrostomy for Complicated Anterior Urethral Strictures: Indications and Patient's Choice. An Analysis at a Single Institution
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Perineal urethrostomy for complicated anterior urethral strictures: indications and patient’s choice. An analysis at a single institution Wesley Verla , Willem Oosterlinck , Marjan Waterloos , Anne-Franc¸oise Spinoit , Nicolaas Lumen PII: DOI: Reference:
S0090-4295(20)30084-4 https://doi.org/10.1016/j.urology.2019.11.064 URL 21955
To appear in:
Urology
Received date: Revised date: Accepted date:
19 September 2019 15 November 2019 20 November 2019
Please cite this article as: Wesley Verla , Willem Oosterlinck , Marjan Waterloos , Anne-Franc¸oise Spinoit , Nicolaas Lumen , Perineal urethrostomy for complicated anterior urethral strictures: indications and patient’s choice. An analysis at a single institution, Urology (2020), doi: https://doi.org/10.1016/j.urology.2019.11.064
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Elsevier Inc. All rights reserved.
1 Perineal urethrostomy for complicated anterior urethral strictures: indications and patient’s choice. An analysis at a single institution. Wesley Verla1,2, Willem Oosterlinck1, Marjan Waterloos1, Anne-Françoise Spinoit1, Nicolaas Lumen1 1
Dept. of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent,
Belgium. 2
Corresponding author: Wesley Verla Email Address: [email protected] Tel.: (+32) 9 332 22 76 Fax: (+32) 9 332 38 89 ORCID: 0000-0001-5755-7078
Other Email Addresses: Willem Oosterlinck: [email protected] Marjan Waterloos: [email protected] Anne-Françoise Spinoit: [email protected] Nicolaas Lumen: [email protected] Manuscript word count (without abstract, references, tables and figures): 2120 Abstract word count: 249 Key-words: urethral stricture; urethroplasty; perineal urethrostomy; multi-stage therapy
2 Acknowledgements The authors have nothing to acknowledge.
Support/Financial Disclosures The authors report no financial disclosures. No funding was obtained fort his study.
3 Abstract Objectives: To explore indications for a definitive perineal urethrostomy (PU). To objectify the proportion of patients not completing the final stage procedure in an intended multi-stage urethroplasty. To analyze the incentives for both of these scenarios.
Materials and methods: Since 2000, data of all men undergoing urethroplasty at our center have been collected in a database. This study included patients with a definitive PU and patients after ≥1 stages of an intended multi-stage urethroplasty. Patients <18y or with a follow-up <3m were excluded. Descriptive statistics were used and groups were compared with non-parametric statistical tests.
Results: Among 1015 urethroplasties, 34 patients underwent a definitive PU and 63 underwent ≥1 stages of an intended multi-stage urethroplasty with a median (IQR) follow-up of respectively 57 (31-120) and 32 (14-101) months. In the definitive PU group, patients were significantly older (p<0.001) and had more cardiovascular comorbidity (p=0.01), panurethral stricture disease (p=0.02) and longer strictures (p=0.02) than patients in the multi-stage urethroplasty group. Half of the definitive PUs were surgeon driven and 33% were patient driven. Final stage procedures were completed by 35/63 (56%) patients. Patients not completing the final stage were significantly older (p=0.001).
4 Conclusions: Definitive PU is particularly performed in older patients with worse cardiovascular condition, panurethral stricture disease and longer strictures. PU is often explicitly chosen by well informed patients and as nearly half of the patients refuse closure of the urethrostomy after the first stage, a definitive PU should be proposed as reasonable alternative to complicated urethral reconstruction from the start, especially in older patients.
5 Abbreviations
- FFS = failure-free survival - IQR = interquartile range - N/A = not applicable - Preop = preoperative - PU = perineal urethrostomy - SD = standard deviation - UTI = urinary tract infection
6 Introduction Urethroplasty is recognized as the gold standard treatment to restore urethral patency in case of urethral stricture disease1. However, in some patients suffering from this condition, further efforts to restore the patency of the entire urethra will be abandoned and a definitive perineal urethrostomy (PU) will be constructed 2. Apart from that, it has also been shown that a certain subset of patients undergoing a multistage urethroplasty does not complete the final stage procedure and prefers to keep the temporary urethrostomy as a definitive solution for their anterior urethral stricture3. The aim of this study is to explore the indications for a definitive PU at a tertiary referral center for urethral stricture disease and to objectify the proportion of patients not completing the final stage procedure in an intended multi-stage urethroplasty. Additionally, this study aims to give a description of the incentives for both of the aforementioned scenarios and scrutinizes which particular patients do not complete their foreseen final stage procedure.
7 Materials and methods Patients Since 2000, data of all male patients undergoing urethroplasty for urethral stricture disease at Ghent University Hospital have been collected in a database. Since 2008, this database has been prospectively maintained. For this analysis, two groups of patients were included: patients that underwent a definitive PU and patients that underwent 1 or more stages of an intended multi-stage urethroplasty. Patients <18 years and patients with a follow-up <3 months were excluded from this study, as were patients in whom the evaluation and planning of a final stage procedure (after a completed first stage procedure) had not taken place yet.
All included patients
provided an informed consent and approval by the local Ethics Committee was obtained (UZG2008/234). Surgical and perioperative standards Our surgical techniques and perioperative care for PUs have been described earlier2,4. As regards multi-stage urethroplasties, the staged Johanson technique represents our standard approach4. In patients with a poor quality or very narrow urethral plate, a free graft was placed in a dorsal inlay fashion to augment the urethra and to allow retubularization at the final stage of the procedure4. Patients were scheduled to revisit the urology department 3 months after their first stage procedure for a postoperative evaluation of the urethra and to discuss a subsequent final stage of the procedure. Follow-up Follow-up visits were scheduled after 3 months, after 12 months and annually thereafter, including history taking, physical examination and uroflowmetry. In
8 patients with obstructive voiding symptoms or an obstructive voiding curve on uroflowmetry (<15 mL/s), a supplementary urethrography and/or urethroscopy were performed to assess potential failure. Statistical analyses Baseline characteristics as well as surgical and perioperative characteristics were analyzed using descriptive statistics. Baseline characteristics were compared between the definitive PU and multi-stage urethroplasty group with the Mann-Whitney U-test or Fisher’s exact test when appropriate. Duration of follow-up was calculated as the interval between the operation date (last stage procedure in case of multistage urethroplasty) and the moment of latest follow-up. Stricture length was recorded as measured peroperatively. Stricture etiology, comorbidities and prior urethral interventions were assessed through thorough history taking. Postoperative complications (<90d) were categorized according to the Clavien-Dindo classification system5. In case of a multi-stage urethroplasty, complications after all stages were recorded. Failure-free survival (FFS) estimates were analyzed using Kaplan-Meier statistics. Herein, a functional definition of failure was used: any need for further urethral instrumentation, including simple dilation6. Patients were censored at the moment of latest follow-up or at the time of death. The Log-Rank test was used to compare FFS between the definitive PU group and the patients from the multi-stage urethroplasty group that actually completed the final stage of the procedure. The incentives for the creation of a definitive PU were retrieved from the electronic patient file and categorized into one of the following categories: ‘unknown’, ‘surgeon driven’, ‘patient driven’, ‘surgeon + patient driven’ and ‘troublesome suprapubic
9 catheter’. Our electronical medical file consists of a specific box in which the proposed treatment options are listed and another particular box in which the definitive treatment decision and incentive are clarified. If these boxes remained blank or contained unclear information, patients were considered part of the ‘unknown’ category. The ‘surgeon driven’ category represents cases in which the decision to construct a definitive PU was primarily driven by the surgeon as it was deemed the only valuable option left for the patient concerned. The ‘patient driven’ category represents cases in which this decision was primarily made by the patient himself after extensive counseling about the potential reconstructive options. The ‘troublesome suprapubic catheter’ category represents a separate group of patients who were living with a lifelong suprapubic catheter, but who wanted an alternative because of their troublesome experience with it (e.g. bladder spasms, obstruction of the tube, infection). As regards the multi-stage urethroplasty group, the proportion of patients not completing the final stage procedure was analyzed, as were the incentives to do so, which were categorized into one of the following: ‘unknown’, ‘satisfied after first stage procedure’ and ‘progressive stricture disease prohibiting retubularization’. This last category represents failures after the first stage procedure in which the urethrostomy suffers from ongoing stricture formation. In these cases, the urethra was left open and the urethrostomy was surgically revised. Within the multi-stage urethroplasty group, patients with and without completion of the final stage procedure were compared using the Mann-Whitney U-test or Fisher’s exact test when appropriate. We hypothesized that patients not completing the final stage procedure would be significantly older and would have undergone significantly more urethroplasties in the past.
10 All statistical tests were 2-sided and p-values <0.05 were considered statistically significant. Analyses were performed using SPSS® 25.0.
Results Out of a database including data of 1015 urethroplasties, a total of 97 patients met the inclusion criteria, of which 34 patients underwent a definitive PU and 63 patients underwent 1 or more stages of an intended multi-stage urethroplasty. Median (interquartile range (IQR)) follow-up of the definitive PU and multi-stage urethroplasty group was respectively 57 (31-120) and 32 (14-101) months. Baseline characteristics are represented in table 1. In the definitive PU group, patients were significantly older (p<0.001) and suffered significantly more from a cardiovascular comorbidity (p=0.01) than patients in the multi-stage urethroplasty group. Also, the definitive PU group contained significantly more panurethral stricture disease (p=0.02) and longer strictures in general (p=0.02). For both groups, the number of prior urethroplasties is illustrated in supplementary figure 1. Surgical and perioperative characteristics are represented in table 2. Out of the 63 patients from the multi-stage urethroplasy group, 35 (56%) patients completed the final stage procedure. The complication rate after a definitive PU or a multi-stage urethroplasty was respectively 26% and 35%, mainly involving low-grade complications. The grade 3 complication after definitive PU involved a case of wound dehiscence requiring surgical reintervention. In the multi-stage urethroplasty group, grade 3 complications involved abscess formation, fistula formation and wound dehiscence in respectively 2 (3.2%), 3 (4.8%) and 2 (3.2%) patients, all requiring surgical reintervention.
11 The 1 year, 2 year and 5 year FFS estimates (standard deviation (SD)) were respectively 94% (4.1), 87% (5.9) and 83% (6.9) for the definitive PU group and 96% (3.6), 92% (5.8) and 92% (5.8) for the patients from the multi-stage urethroplasty group that actually completed the final stage procedure (p=0.8). Incentives for the creation of a definitive PU and for non-completion of a final stage procedure in an intended multi-stage urethroplasty are represented in table 3. This table shows that half of the definitive PUs were mainly surgeon driven and that 33% of the cases were patient driven. As regards patients not completing a second stage procedure, the majority (15/28, 54%) stated to be satisfied with the situation after the first stage procedure and therefore to be unwilling to undergo the final stage of the procedure. In 3/4 failures after the first stage procedure, surgical revision involved resection of fibrosis at the neomeatus and reconstruction of the existing urethrostomy. The other patient suffering from a failure had a stenosis of the neomeatus and another short, bulbar stricture after his first stage Johanson procedure. He was treated with a definitive Blandy perineostomy. Comparison of patients with and without a final stage procedure shows that patients not completing the final stage procedure were significantly older (p=0.001) (table 4). Nevertheless, both groups had undergone a similar amount of prior urethroplasties (p=0.5) (table 4). As additional analysis, patients with a definitive PU were compared to patients without a final stage procedure in an intended multi-stage urethroplasty (supplementary table 1). Compared to patients with a definitive PU, patients with an intended, but not finalized, multi-stage urethroplasty were significantly younger (p=0.03) and had shorter (p=0.008) and less multifocal (p=0.005) strictures.
12 Discussion Definitive PU remains a rare intervention for urethral stricture disease as it was used in only 34 patients (3.3%) out of 1015 cases. In 22 of these patients (2.2%), the definitive PU was considered the only reasonable option left by experienced urethral surgeons (W.O. and N.L.). Be that as it may, 11/34 patients explicitly chose for a definitive PU to avoid the risk of complicated reconstructive surgery or to stop the complications of a suprapubic catheter and 28/63 patients scheduled for a multistage urethroplasty kept the temporary urethrostomy as a definitive solution. Patients in whom a definitive PU was constructed were found to be significantly older and had significantly more cardiovascular comorbidity, panurethral stricture disease and longer strictures than those in whom a multi-stage urethroplasty was initially scheduled. Since nearly half of the patients to whom a final stage procedure is proposed, prefers to continue life with the urethrostomy, it seems more appropriate to propose a definitive PU as first option for complex anterior urethral strictures, especially in older patients (table 3). This group of patients had the personal experience of living with a urethrostomy during at least 3 months and prefers this condition over the risk of stricture recurrence an potential complications after closure of the urethrostomy. A better judgment on living with this condition seems hard to imagine. The results of our study match with those of Fuchs et al.7 who described a series of 403 complex anterior urethral strictures of which 19% was treated with a PU. At their center, PU was increasingly used over time with growing experience: from 4.3% in 2008 to 39% of the cases in 2017. The reason for that was the significantly higher success rate after PU (95%) compared to grafts or flaps. Moreover, they also found that patients treated with a PU were older and had longer strictures than those
13 treated with urethral reconstruction. In 2004, Peterson et al.8 already advocated for PU in
lichen sclerosus related strictures, a condition that yields high stricture
recurrence rates. The same plea was made by Patel et al.9 who described a 93% success rate after PU and only a 73% success rate after free graft urethroplasty for lichen sclerosus related strictures. In 2009, the to our knowledge largest study on PU from Barbagli et al.3 involved a quality of life analysis in 173 PUs in the context of a staged urethroplasty. Satisfaction with this condition was very high as 97% was either ‘satisfied’ or ‘very satisfied’. Final stage closure of the urethrostomy was refused by 127 patients (73%) and a revision of the PU was required in 30%, which may be explained by the long follow-up in this series (median follow-up of 62 months). Recently, Murphy et al.10 reported on urinary and sexual outcome after treatment in 131 complex urethral strictures. Of these strictures, 44 were treated with PU with a failure rate of 15% after 2 years of follow-up, while this was 30% in the urethral reconstruction group. Both groups had a similar improvement of urinary function and stable sexual function after surgery which motivated them to increasingly propose a definitive PU as a good solution for complex cases. Be that as it may, when proposing a definitive PU, one needs to bear in mind that 5 to 30% of the cases will need revisional surgery and the patient needs to be counseled accordingly2,3,7,9,11. Limitations of our study involve the small number of patients and its retrospective design which did not allow to find a motivation for the preferred procedure in 15 cases. Nevertheless, we established that, after counseling, PU is often chosen by the patient himself to stop invalidating consequences of urethral stricture disease. This
14 was especially true for the older patients. Another limitation of the study is represented by the lack of Patient-Reported Outcome Measures (PROM) questionnaires evaluating functional outcome. However, it is unlikely that quality of life and sexual function will impair after PU10, particularly when the PU is chosen by the patient himself. For patients that are condemned to a PU, for instance after penectomy, this is different, as we described in an earlier study showing lower quality of life in patients receiving a PU as part of the surgical treatment for a malignancy2.
Conclusion Definitive PU represents a rarely used solution at our center and is particularly performed in older patients with worse cardiovascular condition, panurethral stricture disease and longer strictures than patients scheduled for multi-stage urethroplasty. PU is often explicitly chosen by the well informed patient and as nearly half of the patients refuse closure of the urethrostomy after a first stage procedure, it seems more appropriate to propose a definitive PU from the start as a reasonable alternative to complicated urethral reconstruction, especially in older patients.
15 References 1.
Wong SSW, Aboumarzouk OM, Narahari R, O’Riordan A, Pickard R. Simple urethral dilatation, endoscopic urethrotomy, and urethroplasty for urethral stricture disease in adult men. Cochrane database Syst Rev. 2012;12:CD006934. doi:10.1002/14651858.CD006934.pub3
2.
Lumen N, Beysens M, Van Praet C, et al. Perineal urethrostomy: Surgical and functional evaluation of two techniques. Biomed Res Int. 2015;2015. doi:10.1155/2015/365715
3.
Barbagli G, De Angelis M, Romano G, Lazzeri M. Clinical outcome and quality of life assessment in patients treated with perineal urethrostomy for anterior urethral stricture disease. J Urol. 2009;182(2):548-557. doi:10.1016/j.juro.2009.04.012
4.
Verla W, Oosterlinck W, Spinoit A-F, Waterloos M. A Comprehensive Review Emphasizing Anatomy, Etiology, Diagnosis, and Treatment of Male Urethral Stricture Disease. Biomed Res Int. 2019;2019:9046430. doi:10.1155/2019/9046430
5.
Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205-213. doi:10.1097/01.SLA.0000133083.54934.AE
6.
Erickson BA, Elliott SP, Voelzke BB, et al. Multi-institutional 1-year bulbar urethroplasty outcomes using a standardized prospective cystoscopic follow-up protocol. Urology. 2014;84(1):213-216. doi:10.1016/j.urology.2014.01.054
7.
Fuchs JS, Shakir N, McKibben MJ, et al. Changing Trends in Reconstruction of Complex Anterior Urethral Strictures: From Skin Flap to Perineal Urethrostomy. Urology. 2018;122:169-173. doi:10.1016/j.urology.2018.08.009
8.
Peterson AC, Palminteri E, Lazzeri M, Guanzoni G, Barbagli G, Webster GD. Heroic measures may not always be justified in extensive urethral stricture due to lichen sclerosus (balanitis xerotica obliterans). Urology. 2004;64(3):565-568. doi:10.1016/j.urology.2004.04.035
9.
Patel CK, Buckley JC, Zinman LN, Vanni AJ. Outcomes for Management of Lichen Sclerosus Urethral Strictures by 3 Different Techniques. Urology. 2016;91:215-221. doi:10.1016/j.urology.2015.11.057
10.
Murphy GP, Fergus KB, Gaither TW, et al. Urinary and Sexual Function after Perineal Urethrostomy for Urethral Stricture Disease: An Analysis from the TURNS. J Urol. 2019;201(5):956-961. doi:10.1097/JU.0000000000000027
11.
Lopez JCR, Gomez EG, Carrillo AA, Castineira RC, Tapia MJR. Perineostomy: the last oportunity. Int Braz J Urol. 41(1):91-98; discussion 99-100. doi:10.1590/S1677-5538.IBJU.2015.01.13
16 Supplementary figure and table legends
Supplementary figure 1. Number of prior urethroplasties Legend: PU = perineal urethrostomy
Supplementary table 1. Comparison of patients with a definitive PU and patients without a final stage procedure in an intended multi-stage urethroplasty Legend: PU = perineal urethrostomy; IQR = interquartile range; cm = centimeters. P-values <0.05 are highlighted in bold.
17 Table 1. Baseline characteristics Definitive PU
Median follow-up (months) (IQR) Median age (years) (IQR) Median stricture length (cm) (IQR) Stricture location n (%) Penile Bulbomambranous Multifocal Panurethral Stricture etiology n (%) Idiopathic Iatrogenic Failed hypospadias repair External trauma Lichen sclerosus Comorbidities n (%) Smoking Diabetes Cardiovascular comorbidity Pulmonary comorbidity Prior urethral interventions n (%) None ≥1 endoscopic interventions ≥1 urethroplasties Median number of prior urethroplasties (IQR) Suprapubic tube n (%)
(n = 34) 57 (31-120) 64 (56-74) 10.0 (4.5-15.0)
Multi-stage urethroplasty (n = 63) 32 (14-101) 49 (40-59) 7.0 (3.0-10.0)
0.8 <0.001 0.02
6 (18) 9 (26) 8 (24) 11 (32)
39 (62) 10 (16) 6 (9.5) 8 (13)
<0.001 0.3 0.061 0.02
10 (29) 18 (53) 4 (12) 0 (0) 6 (18)
12 (19) 33 (52) 17 (27) 4 (6.3) 14 (22)
0.3 >0.9 0.1 0.3 0.8
6 (18) 4 (12) 11 (33) 5 (15)
18 (31) 4 (6.6) 7 (12) 6 (9.9)
0.5 0.4 0.01 0.5
6 (18) 18 (53) 23 (68) 1 (0-1)
13 (21) 33 (52) 37 (59) 1 (0-1)
0.8 >0.9 0.5 0.2
11 (32)
10 (16)
0.074
Legend: PU = perineal urethrostomy; IQR = interquartile range; cm = centimeters. P-values <0.05 are highlighted in bold.
pvalue
18 Table 2. Surgical and perioperative characteristics Definitive PU
Preop UTI n (%) Type of definitive perineostomy n (%) Johanson Blandy Multi-stage urehtroplasty n (%) First stage completed Final stage completed Complications (Clavien-Dindo) n (%) None Grade 1 Grade 2 Grade 3
(n = 34) 9 (27)
Multi-stage urethroplasty (n = 63) 10 (16)
15 (44) 19 (56)
N/A N/A
N/A N/A
63 (100) 35 (56)
25 (74) 4 (12) 4 (12) 1 (2.9)
41 (65) 7 (11) 9 (14) 6 (9.5)
Legend: PU = perineal urethrostomy; Preop = preoperative; UTI = urinary tract infection; N/A = not applicable; FFS = failure-free survival; y = year.
Table 3. Incentives for the creation of a definitive PU and for non-completion of a final stage procedure in an intended multi-stage urethroplasty Incentives for definitive PU (n = 34) Unknown Surgeon driven Patient driven Surgeon + patient driven Troublesome suprapubic catheter for non-completion of a final stage procedure (n = 28) Unknown Satisfied after first stage procedure Progressive stricture disease prohibiting retubularization Legend: PU = perineal urethrostomy
n (%) 6 (18) 17 (50) 4 (12) 5 (15) 2 (5.9) 9 (32) 15 (54) 4 (14)
19 Table 4. Comparison of patients with and without a final stage procedure in an intended multi-stage urethroplasty
Median follow-up (months) (IQR) Median age (years) (IQR) Median stricture length (cm) (IQR) Stricture location n (%) Penile Bulbomambranous Multifocal Panurethral Stricture etiology n (%) Idiopathic Iatrogenic Failed hypospadias repair External trauma Lichen sclerosus Comorbidities n (%) Any comorbidity Diabetes Cardiovascular comorbidity Pulmonary comorbidity Median number of prior urethroplasties (IQR)
Patients with a final stage procedure (n = 35) 32 (10-73) 46 (38-53) 8.0 (3.4-10.0)
Patients without a final stage procedure (n = 28) 35 (16-119) 57 (42-70) 5.0 (2.5-7.0)
p-value
21 (60) 4 (11) 6 (17) 4 (11)
18 (64) 6 (22) 0 (0) 4 (14)
0.8 0.1 0.03 >0.9
6 (17) 17(49) 9 (26) 3 (8.6) 9 (26)
6 (22) 16 (57) 8 (29) 1 (3.6) 5 (18)
0.8 0.6 >0.9 0.6 0.6
6 (17) 3 (8.6) 3 (8.6) 2 (5.8) 1 (0-1)
7 (25) 1 (3.6) 4 (14) 4 (14) 1 (0-1)
0.5 0.6 0.4 0.4 0.5
Legend: IQR = interquartile range; cm = centimeters. P-values <0.05 are highlighted in bold.
0.1 0.001 0.1
Perineal urethrostomy for complicated anterior urethral strictures: indications and patient’s choice. An analysis at a single institution Wesley Verla , Willem Oosterlinck , Marjan Waterloos , Anne-Franc¸oise Spinoit , Nicolaas Lumen PII: DOI: Reference:
S0090-4295(20)30084-4 https://doi.org/10.1016/j.urology.2019.11.064 URL 21955
To appear in:
Urology
Received date: Revised date: Accepted date:
19 September 2019 15 November 2019 20 November 2019
Please cite this article as: Wesley Verla , Willem Oosterlinck , Marjan Waterloos , Anne-Franc¸oise Spinoit , Nicolaas Lumen , Perineal urethrostomy for complicated anterior urethral strictures: indications and patient’s choice. An analysis at a single institution, Urology (2020), doi: https://doi.org/10.1016/j.urology.2019.11.064
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Elsevier Inc. All rights reserved.
1 Perineal urethrostomy for complicated anterior urethral strictures: indications and patient’s choice. An analysis at a single institution. Wesley Verla1,2, Willem Oosterlinck1, Marjan Waterloos1, Anne-Françoise Spinoit1, Nicolaas Lumen1 1
Dept. of Urology, Ghent University Hospital, C. Heymanslaan 10, 9000 Ghent,
Belgium. 2
Corresponding author: Wesley Verla Email Address: [email protected] Tel.: (+32) 9 332 22 76 Fax: (+32) 9 332 38 89 ORCID: 0000-0001-5755-7078
Other Email Addresses: Willem Oosterlinck: [email protected] Marjan Waterloos: [email protected] Anne-Françoise Spinoit: [email protected] Nicolaas Lumen: [email protected] Manuscript word count (without abstract, references, tables and figures): 2120 Abstract word count: 249 Key-words: urethral stricture; urethroplasty; perineal urethrostomy; multi-stage therapy
2 Acknowledgements The authors have nothing to acknowledge.
Support/Financial Disclosures The authors report no financial disclosures. No funding was obtained fort his study.
3 Abstract Objectives: To explore indications for a definitive perineal urethrostomy (PU). To objectify the proportion of patients not completing the final stage procedure in an intended multi-stage urethroplasty. To analyze the incentives for both of these scenarios.
Materials and methods: Since 2000, data of all men undergoing urethroplasty at our center have been collected in a database. This study included patients with a definitive PU and patients after ≥1 stages of an intended multi-stage urethroplasty. Patients <18y or with a follow-up <3m were excluded. Descriptive statistics were used and groups were compared with non-parametric statistical tests.
Results: Among 1015 urethroplasties, 34 patients underwent a definitive PU and 63 underwent ≥1 stages of an intended multi-stage urethroplasty with a median (IQR) follow-up of respectively 57 (31-120) and 32 (14-101) months. In the definitive PU group, patients were significantly older (p<0.001) and had more cardiovascular comorbidity (p=0.01), panurethral stricture disease (p=0.02) and longer strictures (p=0.02) than patients in the multi-stage urethroplasty group. Half of the definitive PUs were surgeon driven and 33% were patient driven. Final stage procedures were completed by 35/63 (56%) patients. Patients not completing the final stage were significantly older (p=0.001).
4 Conclusions: Definitive PU is particularly performed in older patients with worse cardiovascular condition, panurethral stricture disease and longer strictures. PU is often explicitly chosen by well informed patients and as nearly half of the patients refuse closure of the urethrostomy after the first stage, a definitive PU should be proposed as reasonable alternative to complicated urethral reconstruction from the start, especially in older patients.
5 Abbreviations
- FFS = failure-free survival - IQR = interquartile range - N/A = not applicable - Preop = preoperative - PU = perineal urethrostomy - SD = standard deviation - UTI = urinary tract infection
6 Introduction Urethroplasty is recognized as the gold standard treatment to restore urethral patency in case of urethral stricture disease1. However, in some patients suffering from this condition, further efforts to restore the patency of the entire urethra will be abandoned and a definitive perineal urethrostomy (PU) will be constructed 2. Apart from that, it has also been shown that a certain subset of patients undergoing a multistage urethroplasty does not complete the final stage procedure and prefers to keep the temporary urethrostomy as a definitive solution for their anterior urethral stricture3. The aim of this study is to explore the indications for a definitive PU at a tertiary referral center for urethral stricture disease and to objectify the proportion of patients not completing the final stage procedure in an intended multi-stage urethroplasty. Additionally, this study aims to give a description of the incentives for both of the aforementioned scenarios and scrutinizes which particular patients do not complete their foreseen final stage procedure.
7 Materials and methods Patients Since 2000, data of all male patients undergoing urethroplasty for urethral stricture disease at Ghent University Hospital have been collected in a database. Since 2008, this database has been prospectively maintained. For this analysis, two groups of patients were included: patients that underwent a definitive PU and patients that underwent 1 or more stages of an intended multi-stage urethroplasty. Patients <18 years and patients with a follow-up <3 months were excluded from this study, as were patients in whom the evaluation and planning of a final stage procedure (after a completed first stage procedure) had not taken place yet.
All included patients
provided an informed consent and approval by the local Ethics Committee was obtained (UZG2008/234). Surgical and perioperative standards Our surgical techniques and perioperative care for PUs have been described earlier2,4. As regards multi-stage urethroplasties, the staged Johanson technique represents our standard approach4. In patients with a poor quality or very narrow urethral plate, a free graft was placed in a dorsal inlay fashion to augment the urethra and to allow retubularization at the final stage of the procedure4. Patients were scheduled to revisit the urology department 3 months after their first stage procedure for a postoperative evaluation of the urethra and to discuss a subsequent final stage of the procedure. Follow-up Follow-up visits were scheduled after 3 months, after 12 months and annually thereafter, including history taking, physical examination and uroflowmetry. In
8 patients with obstructive voiding symptoms or an obstructive voiding curve on uroflowmetry (<15 mL/s), a supplementary urethrography and/or urethroscopy were performed to assess potential failure. Statistical analyses Baseline characteristics as well as surgical and perioperative characteristics were analyzed using descriptive statistics. Baseline characteristics were compared between the definitive PU and multi-stage urethroplasty group with the Mann-Whitney U-test or Fisher’s exact test when appropriate. Duration of follow-up was calculated as the interval between the operation date (last stage procedure in case of multistage urethroplasty) and the moment of latest follow-up. Stricture length was recorded as measured peroperatively. Stricture etiology, comorbidities and prior urethral interventions were assessed through thorough history taking. Postoperative complications (<90d) were categorized according to the Clavien-Dindo classification system5. In case of a multi-stage urethroplasty, complications after all stages were recorded. Failure-free survival (FFS) estimates were analyzed using Kaplan-Meier statistics. Herein, a functional definition of failure was used: any need for further urethral instrumentation, including simple dilation6. Patients were censored at the moment of latest follow-up or at the time of death. The Log-Rank test was used to compare FFS between the definitive PU group and the patients from the multi-stage urethroplasty group that actually completed the final stage of the procedure. The incentives for the creation of a definitive PU were retrieved from the electronic patient file and categorized into one of the following categories: ‘unknown’, ‘surgeon driven’, ‘patient driven’, ‘surgeon + patient driven’ and ‘troublesome suprapubic
9 catheter’. Our electronical medical file consists of a specific box in which the proposed treatment options are listed and another particular box in which the definitive treatment decision and incentive are clarified. If these boxes remained blank or contained unclear information, patients were considered part of the ‘unknown’ category. The ‘surgeon driven’ category represents cases in which the decision to construct a definitive PU was primarily driven by the surgeon as it was deemed the only valuable option left for the patient concerned. The ‘patient driven’ category represents cases in which this decision was primarily made by the patient himself after extensive counseling about the potential reconstructive options. The ‘troublesome suprapubic catheter’ category represents a separate group of patients who were living with a lifelong suprapubic catheter, but who wanted an alternative because of their troublesome experience with it (e.g. bladder spasms, obstruction of the tube, infection). As regards the multi-stage urethroplasty group, the proportion of patients not completing the final stage procedure was analyzed, as were the incentives to do so, which were categorized into one of the following: ‘unknown’, ‘satisfied after first stage procedure’ and ‘progressive stricture disease prohibiting retubularization’. This last category represents failures after the first stage procedure in which the urethrostomy suffers from ongoing stricture formation. In these cases, the urethra was left open and the urethrostomy was surgically revised. Within the multi-stage urethroplasty group, patients with and without completion of the final stage procedure were compared using the Mann-Whitney U-test or Fisher’s exact test when appropriate. We hypothesized that patients not completing the final stage procedure would be significantly older and would have undergone significantly more urethroplasties in the past.
10 All statistical tests were 2-sided and p-values <0.05 were considered statistically significant. Analyses were performed using SPSS® 25.0.
Results Out of a database including data of 1015 urethroplasties, a total of 97 patients met the inclusion criteria, of which 34 patients underwent a definitive PU and 63 patients underwent 1 or more stages of an intended multi-stage urethroplasty. Median (interquartile range (IQR)) follow-up of the definitive PU and multi-stage urethroplasty group was respectively 57 (31-120) and 32 (14-101) months. Baseline characteristics are represented in table 1. In the definitive PU group, patients were significantly older (p<0.001) and suffered significantly more from a cardiovascular comorbidity (p=0.01) than patients in the multi-stage urethroplasty group. Also, the definitive PU group contained significantly more panurethral stricture disease (p=0.02) and longer strictures in general (p=0.02). For both groups, the number of prior urethroplasties is illustrated in supplementary figure 1. Surgical and perioperative characteristics are represented in table 2. Out of the 63 patients from the multi-stage urethroplasy group, 35 (56%) patients completed the final stage procedure. The complication rate after a definitive PU or a multi-stage urethroplasty was respectively 26% and 35%, mainly involving low-grade complications. The grade 3 complication after definitive PU involved a case of wound dehiscence requiring surgical reintervention. In the multi-stage urethroplasty group, grade 3 complications involved abscess formation, fistula formation and wound dehiscence in respectively 2 (3.2%), 3 (4.8%) and 2 (3.2%) patients, all requiring surgical reintervention.
11 The 1 year, 2 year and 5 year FFS estimates (standard deviation (SD)) were respectively 94% (4.1), 87% (5.9) and 83% (6.9) for the definitive PU group and 96% (3.6), 92% (5.8) and 92% (5.8) for the patients from the multi-stage urethroplasty group that actually completed the final stage procedure (p=0.8). Incentives for the creation of a definitive PU and for non-completion of a final stage procedure in an intended multi-stage urethroplasty are represented in table 3. This table shows that half of the definitive PUs were mainly surgeon driven and that 33% of the cases were patient driven. As regards patients not completing a second stage procedure, the majority (15/28, 54%) stated to be satisfied with the situation after the first stage procedure and therefore to be unwilling to undergo the final stage of the procedure. In 3/4 failures after the first stage procedure, surgical revision involved resection of fibrosis at the neomeatus and reconstruction of the existing urethrostomy. The other patient suffering from a failure had a stenosis of the neomeatus and another short, bulbar stricture after his first stage Johanson procedure. He was treated with a definitive Blandy perineostomy. Comparison of patients with and without a final stage procedure shows that patients not completing the final stage procedure were significantly older (p=0.001) (table 4). Nevertheless, both groups had undergone a similar amount of prior urethroplasties (p=0.5) (table 4). As additional analysis, patients with a definitive PU were compared to patients without a final stage procedure in an intended multi-stage urethroplasty (supplementary table 1). Compared to patients with a definitive PU, patients with an intended, but not finalized, multi-stage urethroplasty were significantly younger (p=0.03) and had shorter (p=0.008) and less multifocal (p=0.005) strictures.
12 Discussion Definitive PU remains a rare intervention for urethral stricture disease as it was used in only 34 patients (3.3%) out of 1015 cases. In 22 of these patients (2.2%), the definitive PU was considered the only reasonable option left by experienced urethral surgeons (W.O. and N.L.). Be that as it may, 11/34 patients explicitly chose for a definitive PU to avoid the risk of complicated reconstructive surgery or to stop the complications of a suprapubic catheter and 28/63 patients scheduled for a multistage urethroplasty kept the temporary urethrostomy as a definitive solution. Patients in whom a definitive PU was constructed were found to be significantly older and had significantly more cardiovascular comorbidity, panurethral stricture disease and longer strictures than those in whom a multi-stage urethroplasty was initially scheduled. Since nearly half of the patients to whom a final stage procedure is proposed, prefers to continue life with the urethrostomy, it seems more appropriate to propose a definitive PU as first option for complex anterior urethral strictures, especially in older patients (table 3). This group of patients had the personal experience of living with a urethrostomy during at least 3 months and prefers this condition over the risk of stricture recurrence an potential complications after closure of the urethrostomy. A better judgment on living with this condition seems hard to imagine. The results of our study match with those of Fuchs et al.7 who described a series of 403 complex anterior urethral strictures of which 19% was treated with a PU. At their center, PU was increasingly used over time with growing experience: from 4.3% in 2008 to 39% of the cases in 2017. The reason for that was the significantly higher success rate after PU (95%) compared to grafts or flaps. Moreover, they also found that patients treated with a PU were older and had longer strictures than those
13 treated with urethral reconstruction. In 2004, Peterson et al.8 already advocated for PU in
lichen sclerosus related strictures, a condition that yields high stricture
recurrence rates. The same plea was made by Patel et al.9 who described a 93% success rate after PU and only a 73% success rate after free graft urethroplasty for lichen sclerosus related strictures. In 2009, the to our knowledge largest study on PU from Barbagli et al.3 involved a quality of life analysis in 173 PUs in the context of a staged urethroplasty. Satisfaction with this condition was very high as 97% was either ‘satisfied’ or ‘very satisfied’. Final stage closure of the urethrostomy was refused by 127 patients (73%) and a revision of the PU was required in 30%, which may be explained by the long follow-up in this series (median follow-up of 62 months). Recently, Murphy et al.10 reported on urinary and sexual outcome after treatment in 131 complex urethral strictures. Of these strictures, 44 were treated with PU with a failure rate of 15% after 2 years of follow-up, while this was 30% in the urethral reconstruction group. Both groups had a similar improvement of urinary function and stable sexual function after surgery which motivated them to increasingly propose a definitive PU as a good solution for complex cases. Be that as it may, when proposing a definitive PU, one needs to bear in mind that 5 to 30% of the cases will need revisional surgery and the patient needs to be counseled accordingly2,3,7,9,11. Limitations of our study involve the small number of patients and its retrospective design which did not allow to find a motivation for the preferred procedure in 15 cases. Nevertheless, we established that, after counseling, PU is often chosen by the patient himself to stop invalidating consequences of urethral stricture disease. This
14 was especially true for the older patients. Another limitation of the study is represented by the lack of Patient-Reported Outcome Measures (PROM) questionnaires evaluating functional outcome. However, it is unlikely that quality of life and sexual function will impair after PU10, particularly when the PU is chosen by the patient himself. For patients that are condemned to a PU, for instance after penectomy, this is different, as we described in an earlier study showing lower quality of life in patients receiving a PU as part of the surgical treatment for a malignancy2.
Conclusion Definitive PU represents a rarely used solution at our center and is particularly performed in older patients with worse cardiovascular condition, panurethral stricture disease and longer strictures than patients scheduled for multi-stage urethroplasty. PU is often explicitly chosen by the well informed patient and as nearly half of the patients refuse closure of the urethrostomy after a first stage procedure, it seems more appropriate to propose a definitive PU from the start as a reasonable alternative to complicated urethral reconstruction, especially in older patients.
15 References 1.
Wong SSW, Aboumarzouk OM, Narahari R, O’Riordan A, Pickard R. Simple urethral dilatation, endoscopic urethrotomy, and urethroplasty for urethral stricture disease in adult men. Cochrane database Syst Rev. 2012;12:CD006934. doi:10.1002/14651858.CD006934.pub3
2.
Lumen N, Beysens M, Van Praet C, et al. Perineal urethrostomy: Surgical and functional evaluation of two techniques. Biomed Res Int. 2015;2015. doi:10.1155/2015/365715
3.
Barbagli G, De Angelis M, Romano G, Lazzeri M. Clinical outcome and quality of life assessment in patients treated with perineal urethrostomy for anterior urethral stricture disease. J Urol. 2009;182(2):548-557. doi:10.1016/j.juro.2009.04.012
4.
Verla W, Oosterlinck W, Spinoit A-F, Waterloos M. A Comprehensive Review Emphasizing Anatomy, Etiology, Diagnosis, and Treatment of Male Urethral Stricture Disease. Biomed Res Int. 2019;2019:9046430. doi:10.1155/2019/9046430
5.
Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240(2):205-213. doi:10.1097/01.SLA.0000133083.54934.AE
6.
Erickson BA, Elliott SP, Voelzke BB, et al. Multi-institutional 1-year bulbar urethroplasty outcomes using a standardized prospective cystoscopic follow-up protocol. Urology. 2014;84(1):213-216. doi:10.1016/j.urology.2014.01.054
7.
Fuchs JS, Shakir N, McKibben MJ, et al. Changing Trends in Reconstruction of Complex Anterior Urethral Strictures: From Skin Flap to Perineal Urethrostomy. Urology. 2018;122:169-173. doi:10.1016/j.urology.2018.08.009
8.
Peterson AC, Palminteri E, Lazzeri M, Guanzoni G, Barbagli G, Webster GD. Heroic measures may not always be justified in extensive urethral stricture due to lichen sclerosus (balanitis xerotica obliterans). Urology. 2004;64(3):565-568. doi:10.1016/j.urology.2004.04.035
9.
Patel CK, Buckley JC, Zinman LN, Vanni AJ. Outcomes for Management of Lichen Sclerosus Urethral Strictures by 3 Different Techniques. Urology. 2016;91:215-221. doi:10.1016/j.urology.2015.11.057
10.
Murphy GP, Fergus KB, Gaither TW, et al. Urinary and Sexual Function after Perineal Urethrostomy for Urethral Stricture Disease: An Analysis from the TURNS. J Urol. 2019;201(5):956-961. doi:10.1097/JU.0000000000000027
11.
Lopez JCR, Gomez EG, Carrillo AA, Castineira RC, Tapia MJR. Perineostomy: the last oportunity. Int Braz J Urol. 41(1):91-98; discussion 99-100. doi:10.1590/S1677-5538.IBJU.2015.01.13
16 Supplementary figure and table legends
Supplementary figure 1. Number of prior urethroplasties Legend: PU = perineal urethrostomy
Supplementary table 1. Comparison of patients with a definitive PU and patients without a final stage procedure in an intended multi-stage urethroplasty Legend: PU = perineal urethrostomy; IQR = interquartile range; cm = centimeters. P-values <0.05 are highlighted in bold.
17 Table 1. Baseline characteristics Definitive PU
Median follow-up (months) (IQR) Median age (years) (IQR) Median stricture length (cm) (IQR) Stricture location n (%) Penile Bulbomambranous Multifocal Panurethral Stricture etiology n (%) Idiopathic Iatrogenic Failed hypospadias repair External trauma Lichen sclerosus Comorbidities n (%) Smoking Diabetes Cardiovascular comorbidity Pulmonary comorbidity Prior urethral interventions n (%) None ≥1 endoscopic interventions ≥1 urethroplasties Median number of prior urethroplasties (IQR) Suprapubic tube n (%)
(n = 34) 57 (31-120) 64 (56-74) 10.0 (4.5-15.0)
Multi-stage urethroplasty (n = 63) 32 (14-101) 49 (40-59) 7.0 (3.0-10.0)
0.8 <0.001 0.02
6 (18) 9 (26) 8 (24) 11 (32)
39 (62) 10 (16) 6 (9.5) 8 (13)
<0.001 0.3 0.061 0.02
10 (29) 18 (53) 4 (12) 0 (0) 6 (18)
12 (19) 33 (52) 17 (27) 4 (6.3) 14 (22)
0.3 >0.9 0.1 0.3 0.8
6 (18) 4 (12) 11 (33) 5 (15)
18 (31) 4 (6.6) 7 (12) 6 (9.9)
0.5 0.4 0.01 0.5
6 (18) 18 (53) 23 (68) 1 (0-1)
13 (21) 33 (52) 37 (59) 1 (0-1)
0.8 >0.9 0.5 0.2
11 (32)
10 (16)
0.074
Legend: PU = perineal urethrostomy; IQR = interquartile range; cm = centimeters. P-values <0.05 are highlighted in bold.
pvalue
18 Table 2. Surgical and perioperative characteristics Definitive PU
Preop UTI n (%) Type of definitive perineostomy n (%) Johanson Blandy Multi-stage urehtroplasty n (%) First stage completed Final stage completed Complications (Clavien-Dindo) n (%) None Grade 1 Grade 2 Grade 3
(n = 34) 9 (27)
Multi-stage urethroplasty (n = 63) 10 (16)
15 (44) 19 (56)
N/A N/A
N/A N/A
63 (100) 35 (56)
25 (74) 4 (12) 4 (12) 1 (2.9)
41 (65) 7 (11) 9 (14) 6 (9.5)
Legend: PU = perineal urethrostomy; Preop = preoperative; UTI = urinary tract infection; N/A = not applicable; FFS = failure-free survival; y = year.
Table 3. Incentives for the creation of a definitive PU and for non-completion of a final stage procedure in an intended multi-stage urethroplasty Incentives for definitive PU (n = 34) Unknown Surgeon driven Patient driven Surgeon + patient driven Troublesome suprapubic catheter for non-completion of a final stage procedure (n = 28) Unknown Satisfied after first stage procedure Progressive stricture disease prohibiting retubularization Legend: PU = perineal urethrostomy
n (%) 6 (18) 17 (50) 4 (12) 5 (15) 2 (5.9) 9 (32) 15 (54) 4 (14)
19 Table 4. Comparison of patients with and without a final stage procedure in an intended multi-stage urethroplasty
Median follow-up (months) (IQR) Median age (years) (IQR) Median stricture length (cm) (IQR) Stricture location n (%) Penile Bulbomambranous Multifocal Panurethral Stricture etiology n (%) Idiopathic Iatrogenic Failed hypospadias repair External trauma Lichen sclerosus Comorbidities n (%) Any comorbidity Diabetes Cardiovascular comorbidity Pulmonary comorbidity Median number of prior urethroplasties (IQR)
Patients with a final stage procedure (n = 35) 32 (10-73) 46 (38-53) 8.0 (3.4-10.0)
Patients without a final stage procedure (n = 28) 35 (16-119) 57 (42-70) 5.0 (2.5-7.0)
p-value
21 (60) 4 (11) 6 (17) 4 (11)
18 (64) 6 (22) 0 (0) 4 (14)
0.8 0.1 0.03 >0.9
6 (17) 17(49) 9 (26) 3 (8.6) 9 (26)
6 (22) 16 (57) 8 (29) 1 (3.6) 5 (18)
0.8 0.6 >0.9 0.6 0.6
6 (17) 3 (8.6) 3 (8.6) 2 (5.8) 1 (0-1)
7 (25) 1 (3.6) 4 (14) 4 (14) 1 (0-1)
0.5 0.6 0.4 0.4 0.5
Legend: IQR = interquartile range; cm = centimeters. P-values <0.05 are highlighted in bold.
0.1 0.001 0.1