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Clinical Outcome and Quality of Life Assessment in Patients Treated With Perineal Urethrostomy for Anterior Urethral Stricture Disease
Clinical Outcome and Quality of Life Assessment in Patients Treated With Perineal Urethrostomy for Anterior Urethral Stricture Disease Guido Barbagli, Michele De Angelis, Giuseppe Romano and Massimo Lazzeri* From the Center for Reconstructive Urethral Surgery (GB) and Unità Operativa Urologia, Ospedale San Donato (MDA, GR), Arezzo, and Department of Urology, Santa Chiara-Firenze, Florence (ML), Italy Submitted for publication December 4, 2008. Nothing to disclose. * Correspondence: Department of Urology, Santa Chiara, P.zza Indipendenza, 11 50129 Florence, Italy (telephone: ⫹39 055 50381; FAX: ⫹39 055 480676; e-mail: [email protected]).
Editor’s Note: This article is the third of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 808 and 809.
Purpose: We performed a quality of life assessment for patients treated with perineal urethrostomy for anterior urethral stricture disease. Materials and Methods: We retrospectively reviewed 173 patients (median age 55 years) who underwent perineal urethrostomy (from 1978 to 2007) as part of a plan for a staged urethroplasty repair for a complex anterior urethral stricture. The perineostomy was made using flap urethroplasty. The clinical outcome was considered a failure when postoperative instrumentation was needed. A questionnaire was used to evaluate patient quality of life and satisfaction. Results: Stricture etiology was unknown in 50.3% of the cases, lichen sclerosus in 17.3%, catheter in 13.3%, instrumentation in 8.7%, failed hypospadias repair in 4.6%, trauma in 4.1% and infection in 1.7%. Stricture length was 1 to less than 2 cm in 1.2% of cases, 2 to less than 3 cm in 3.5%, 3 to less than 4 cm in 12.1%, 4 to less than 5 cm in 13.8%, 5 to less than 6 cm in 7.5%, greater than 6 cm in 4.1% and panurethral in 57.8%. Of 173 patients 91 (52.6%) underwent prior urethroplasty. Median followup length was 62 months (range 12 to 361). Of 173 cases 121 (70%) were successful and 52 (30%) were failures, requiring revision of the perineostomy. Of 173 patients 135 (78%) were satisfied with the results obtained with surgery, 33 (19.1%) were very satisfied, 127 (73.4%) with a median age of 57 years (range 23 to 85) refused to do the second stage of urethroplasty and 46 (26.6%) with a median age of 47.5 years (range 27 to 72) are currently on a waiting list for the second stage of urethroplasty. Conclusions: Perineostomy is a necessary procedure for patients with complex urethral pathology and satisfaction rates are high. Key Words: urethra, urethral stricture, urinary diversion, surgical stomas
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STAGED urethroplasty represents an old form of urethral reconstruction. The surgical technique of marsupialization of the diseased urethra with delayed reconstruction was first described as early as 1914 by Russell.1 In 1953 the Swedish urologist Johanson widely refined and popularized the use of 2-stage techniques in reconstruction of the male urethra stricture, applying the principle of the buried strip
of intact epithelium previously described by Duplay, Marion and Denis Browne for hypospadias repair.2 Johanson’s technique was later refined by Turner-Warwick, who described a new 2-stage flap urethroplasty with regard to the more posterior stricture.3 TurnerWarwick’s technique was modified by Blandy because he found this operation exceedingly difficult to perform, having trouble with restenosis of the apex of
0022-5347/09/1822-0548/0 THE JOURNAL OF UROLOGY® Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 182, 548-557, August 2009 Printed in U.S.A. DOI:10.1016/j.juro.2009.04.012
PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
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complex anterior urethral stricture diseases, in an observational descriptive study to define the clinical outcome, and patient quality of life and satisfaction.
MATERIALS AND METHODS
Figure 1. 艚-shaped perineal incision
the flap near the verumontanum. In 1968 he described the 艚-shaped scrotal flap urethroplasty which was much easier to perform and did not seem to result in recurrent stenosis.4,5 Later Blandy recounted the way in which he developed this surgical technique, believing then that it was original, but later confessed that this technique or something like it had already been described by Leadbetter, Gil-Vernet, Wells and Williams, and Crawford.5 Over time the standard 2-stage procedures were widely modified. In 1984 Schreiter described a new staged technique using a meshed split-thickness skin graft,6 and Venn and Mundy introduced the use of oral mucosal graft in staged procedures for patients with lichen sclerosus.7 In the era of the 1-stage repair there are still some indications for staged urethroplasty.8 –10 Strictures associated with local adverse conditions such as fistula, false passage, abscess, cancer or a prior unsuccessful complex urethroplasty are best treated with staged procedures.8,9 Another group of patients difficult to treat are those with lichen sclerosus urethral disease or those who have undergone complicated failed hypospadias repair.8–10 Perineal urethrostomy should be a temporary or definitive solution to a complex penile, bulbar or posterior urethral problem. Some patients choose not to have the urethra reconstructed in a second or third stage and continue to void through a perineal urethrostomy. Thus, the first stage becomes the only stage and a definitive procedure.8 We report our experience with 173 patients who underwent temporary or definitive perineal urethrostomy, using 艚-shaped scrotal flap urethroplasty, for
The study is a retrospective chart analysis of 173 patients who underwent perineal urethrostomy for anterior urethral stricture disease from June 1978 to June 2007 as part of a plan for a staged urethroplasty repair of a complex urethral stricture. Patients with posterior urethral strictures were excluded from the study. Preoperative evaluation included clinical history, physical examination, urine culture, residual urine measurement, uroflowmetry, and retrograde and voiding cystourethrography. Since 1998 urethral ultrasound was also performed on all patients. The patient is placed in a normal lithotomy position and a 艚-shaped perineal incision is made (fig. 1). The bulbar urethra is fully opened along its ventral surface and the margins of the spongiosum tissue are closed (fig. 2). The proximal urethral opening is inspected using a nasal speculum to see the verumontanum. The needle used for a 4-zero polyglactin suture is modified (fig. 3) and passed though the spongiosum tissue in front up to the verumontanum (fig. 4). Using this technique 3 stitches are passed
Figure 2. Urethra is ventrally opened and margins of spongiosum tissue are closed for hemostasis.
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PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Figure 3. Curve of needle (4-zero polyglactin suture) is modified into J shape.
in front up to the verumontanum and then into the apex of the 艚-shaped perineal skin flap (fig. 5). The stitches are tied, and the apex of the 艚-shaped perineal skin flap is pushed inside and sutured to the proximal urethral mucosa edge, in front up to the verumontanum (fig. 6). The perineal skin margins are sutured to the bulbar urethral plate margins and a 20Fr Foley catheter is left in place for 10 days (fig. 7). Patients were discharged from the hospital 3 to 5 days after surgery. Clinical outpatient examinations were scheduled at 3, 6 and 9 months postoperatively, and then annually. All patients underwent uroflowmetry with direct examination of the wide opening of the proximal perineal stoma by
Figure 5. Using this technique 3 stitches are passed in front up to verumontanum and then into apex of 艚-shaped perineal skin flap.
nasal speculum. The primary outcome measure was success (no evidence of stricture recurrence) or failure (evidence of stricture recurrence) rate according to age, etiology, stricture
Figure 4. Modified needle is passed though spongiosum tissue (A), tip of needle is retrieved in front up to verumontanum (B), advanced and then withdrawn (C), deeply penetrating into spongiosum body (D).
PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Figure 6. When 3 stitches are tied, apex of 艚-shaped flap is pushed in front up to verumontanum.
length and previous treatments. The surgery was considered a failure when any postoperative instrumentation was needed including dilation. Urine culture was repeated every 4 months in the first year and annually thereafter. When symptoms of decreased force of stream were present voiding urethrography and urethroscopy were repeated. The secondary outcome measure was patient satisfaction and acceptance of this urinary diversion (perineostomy), investigated using a nonvalidated questionnaire that was selfcompleted during the last followup visit. The questionnaire included 7 questions to investigate modifications in urinary function, sexual function and psychological impact, and 5 to evaluate final patient satisfaction or dissatisfaction after surgery. All patients who presented evidence of clinically severe cardiovascular, renal, hepatic, respiratory and neurological diseases, and any conditions that in the judgment of the investigators would interfere with the ability to fill out the questionnaire and to comply with study instructions, that would place the subject at increased risk or that might confound interpretation of study results, were ruled out.
RESULTS Median patient age at surgery was 55 years (range 23 to 85). Of the patients 67 (38.7%) were 23 to 49
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years old, 86 (49.7%) were 50 to 69 and 20 (11.6%) were older than 70 years. Median age according to stricture etiology is reported in table 1. Original stricture etiology was unknown in 87 (50.3%) cases, lichen sclerosus in 30 (17.3%), catheter in 23 (13.3%), instrumentation in 15 (8.7%), failed hypospadias repair in 8 (4.6%), trauma in 7 (4.1%) and infection in 3 (1.7%) (table 1). Stricture length was 1 to less than 2 cm in 2 patients (1.2%), 2 to less than 3 cm in 6 (3.5%), 3 to less than 4 cm in 21 (12.1%), 4 to less than 5 cm in 24 (13.8%), 5 to less than 6 cm in 13 (7.5%), greater than 6 cm in 7 (4.1%) and panurethral in 100 (57.8%) (table 1). Stricture length according to stricture etiology is reported in table 1. Median stricture length (mode) according to stricture etiology was panurethral, and only patients with failed hypospadias repair or traumatic strictures showed a median stricture length (mode) of 3 to 4 cm (table 1). Of 173 patients 150 (86.7%) underwent dilation (6.9%), urethrotomy (9.8%), urethroplasty (9.2%) or multiple treatments (dilation, urethrotomy and urethroplasty) (60.6%) (table 2). Of 173 patients 91 (52.6%) underwent prior failed urethroplasty, namely 8 (8.8%) failed hypospadias repair, 15 (16.5%) penile urethroplasty, 22 (24.1%) end-to-end anastomosis, 14 (15.4%) 1-stage skin graft urethroplasty, 6 (6.6%) 1-stage oral graft urethroplasty, 25 (27.5%) 2-stage repair and 1 (1.1%) 1-stage bladder mucosa graft urethroplasty (tables 3 and 4). In 24 patients (13.9%) a urethral stent was removed during the surgical procedure, and these patients had undergone a minimum of 1 operation and a maximum of 7 operations (mean 3.8) before our surgery. Patients with failed hypospadias repair underwent a minimum of 1 operation and a maximum of 10 operations (mean 4.5), while those with failed urethroplasty underwent a minimum of 1 operation and a maximum of 9 operations (mean 4.1). Of 173 patients 82 (47.4%) had not undergone prior urethroplasty and perineal urethrostomy was selected as the primary procedure (table 3). Median followup length was 62 months (range 12 to 361) (table 5). Patients with lichen sclerosus had a longer median followup (90 months) (table 5). Of 173 cases 121 (70%) were successes and 52 (30%) were failures (table 5). Based on patient age the success rate was 61.2% in men 23 to 49 years old (67 cases), 74.4% in those 50 to 69 years old (86) and 80% in men older than 70 years (20). Based on stricture etiology the success rate was 87.5% for cases of stricture following failed hypospadias repair (8 cases), 73.6% in strictures of unknown etiology (87), 73.3% for strictures following urethral instrumentation (15), 65.2% for strictures caused by a catheter (23), 63.3% for strictures caused by lichen sclerosus (30), 57.1% for traumatic strictures (7) and 33.3% for strictures following infection (3) (table 5). Based on stricture length the success rate was
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Figure 7. Perineal and scrotal skin margins are sutured to urethral margins (A–C), and 20Fr Foley catheter is left in place (D)
85.7% in patients with strictures greater than 6 cm (7 cases), 76.9% in those with 5 to less than 6 cm strictures (13), 71.4% in those with 3 to less than 4 cm strictures (21), 70.8% in those with 4 to less than 5 cm strictures (24), 68% in those with panurethral strictures (100), 66.7% in those with 2 to less than 3 cm strictures (6) and 50% in those with 1 to less than 2 cm strictures (2). Based on having received treatment before surgery the success rate was 75% in patients who underwent dilation (12), 73.9% in patients who had not undergone previous treatment (23), 64.7% in those who had undergone urethrotomy (17), 56.3% in those who had undergone prior urethroplasty (16) and 43.3% in those who had undergone multiple treatments (105) (table 2). In terms of having undergone urethroplasty before surgery the success rate was 73.2% in patients who had not undergone previous urethroplasty (82 cases) and 67% in those who had undergone prior failed urethroplasty (91) (table 3). Based on the type of prior failed repair the success rate
was 100% in patients who had undergone 1-stage bladder mucosa graft urethroplasty (1 case), 87.5% in those who had failed hypospadias repair (8), 83.3% for 1-stage oral graft urethroplasty (6), 68.2% for end-toend anastomosis (22), 64% for 2-stage repair (25), 60% for penile urethroplasty (15) and 57.1% in patients who had undergone 1-stage skin graft urethroplasty (14) (table 4). Of 173 cases 52 (30%) were treatment failures, requiring a new surgical revision of the proximal opening of the perineal urethrostomy. Of these 52 patients 32 (61.6%) required 1 surgical revision, 13 (25%) required 2, 5 (9.6%) required 3, 1 (1.9%) required 4 and 1 (1.9%) required 5 surgical revisions (table 6). Median time free of stricture according to stricture etiology was high in patients with strictures following instrumentation (62 months) or failed hypospadias repair (52.5 months) and low in those with strictures after infection (6 months) (table 5). All patients were able to reply to the 12 questions in the questionnaire. Median patient age at investi-
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Table 1. Etiology of stricture according to patient age and stricture length
No. pts (%) No. pt age (%): 23–49 50–69 Older than 70 Median pt age No. cm stricture (%): 1–2 2–3 3–4 4–5 5–6 Greater than 6 Panurethral Stricture mode
Catheter
Unknown
Infection
Failed Hypospadias
Lichen Sclerosus
Instrumentation
Trauma
Overall
23 (13.3)
87 (50.3)
3 (1.7)
8 (4.6)
30 (17.3)
15 (8.7)
7 (4.1)
173 (100)
9 (39.1) 11 (47.8) 3 (13.1) 54
36 (41.4) 43 (49.4) 8 (9.2) 56
3 (100)
5 (62.5) 3 (37.5)
6 (20) 20 (66.7) 4 (13.3) 57
5 (33.3) 8 (53.3) 2 (13.4) 55
3 (42.9) 1 (14.2) 3 (42.9) 51
67 (38.7) 86 (49.7) 20 (11.6)
2 (8.7) 3 (13) 3 (13) 4 (17.4) 1 (4.4) 10 (43.5) Panurethral
3 (3.5) 11 (12.6) 15 (17.3) 7 (8) 2 (2.3) 49 (56.3) Panurethral
47
48
3 (37.5) 1 (33.3)
2 (66.7) Panurethral
gation by questionnaire was 60 years (range 27 to 86). Of 173 patients who took the questionnaire 145 (84%) replied that the perineal urethrostomy did not cause any problems, and 28 (16%) replied that the perineal urethrostomy had caused psychological problems (32%), urination problems (46%) or sexual activity dysfunction (22%). A total of 141 patients (82%) replied that perineal urethrostomy did not cause any problems with the partner, and 32 (18%) replied that the perineal urethrostomy caused psychological problems (35%), penetration problems (40%) or minor problems (25%) in the relationship with the partner. Of 173 patients 135 (78%) were satisfied with the results obtained with surgery, 33 (19.1%) were very satisfied, 3 (1.7%) were a little satisfied and 2 (1.2%) were dissatisfied. A total of 121 patients (69.9%) considered the results to be good, 45 (26.1%) considered the results excellent, 4 (2.3%) found the results fair and 3 (1.7%) considered the results negative. When asked whether they would undergo this type of operation again 168 patients (97.1%) replied yes and 5 (2.9%) replied no. Patient responses to the questions are summarized in table 7. Of 173 patients 127 (73.4%) with a median age of 57 years (range 23 to 85) refused to undergo the second stage of urethroplasty to restore normal urinary function through the glanular meatus (table 5). Of 173 patients 46 (26.6%) with a median age of 47.5
1 (3.3) 2 (25) 2 (25) 1 (12.5) 3–4 cm
29 (96.7) Panurethral
1 (6.7) 2 (13.3) 2 (13.3) 2 (13.3) 8 (53.4) Panurethral
3 (42.8) 1 (14.3) 2 (28.6) 1 (14.3) 3–4 cm
2 (1.2) 6 (3.5) 21 (12.1) 24 (13.8) 13 (7.5) 7 (4.1) 100 (57.8)
years (range 27 to 72) are currently on a waiting list for the second stage of urethroplasty (table 5). Evaluation of patient satisfaction according to clinical outcome (success vs failure) and median followup is summarized in table 8, and evaluation of patient satisfaction according to patient age is summarized in table 9.
DISCUSSION We evaluated our results according to patient age, stricture etiology, length and prior treatments. In our experience patients younger than 50 years had a success rate of 61.2% and those older than 70 years had a success rate of 80% (table 1). In our previous experience age was not a factor in influencing the success rate of 1-stage bulbar urethroplasty and these results confirm that the use of perineal urethrostomy should not be withheld from patients on the basis of age.11,12 Evaluation of the success rate of the perineal urethrostomy according to stricture etiology demonstrated that the strictures showing a higher success rate (87.5%) were those that followed failed hypospadias repair and strictures showing a lower success rate were those that followed infection (33.3%) (but only 3 cases were recorded) or trauma (57.2%) (table 5). Usually in patients with failed hypospadias repair the bulbar urethra, where the perineal urethrostomy is made, was not involved in previous surgery, and this can explain the high success rate
Table 2. Success rate according to previous treatment Previous Treatment
No. Pts (%)
No. Successes (%)
No. Failures (%)
None Dilation Urethrotomy Urethroplasty Multiple treatments
23 (13.3) 12 (6.9) 17 (9.8) 16 (9.2) 105 (60.6)
17 (73.9) 9 (75) 11 (64.7) 9 (56.3) 75 (43.3)
6 (26.1) 3 (25) 6 (35.3) 7 (43.7) 30 (17.3)
173 (100)
121 (70)
52 (30)
Totals
Table 3. Success rate according to repair history Prior Urethroplasty
No. Pts (%)
No. Successes (%)
No. Failures (%)
None Prior failed urethroplasty
82 (47.4) 91 (52.6)
60 (73.2) 61 (67)
22 (26.8) 30 (33)
173 (100)
121 (70)
52 (30)
Totals
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PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Table 4. Success rate according the type of prior failed repair
Failed hypospadias repair Penile urethroplasty End-to-end anastomosis 1-Stage skin graft urethroplasty 1-Stage oral graft urethroplasty 2-Stage repair 1-Stage bladder mucosa graft urethroplasty Totals
No. Pts (%)
No. Successes (%)
No. Failures (%)
8 (8.8) 15 (16.5) 22 (24.1) 14 (15.4) 6 (6.6) 25 (27.5) 1 (1.1)
7 (87.5) 9 (60) 15 (68.2) 8 (57.1) 5 (83.3) 16 (64) 1 (100)
1 (12.5) 6 (40) 7 (31.8) 6 (42.9) 1 (16.7) 9 (36)
91 (52.6)
61 (67)
30 (33)
in these patients. Instead in patients with previous perineal trauma and stricture repair the urethral tract where the perineal urethrostomy is made is fully involved in the scarring process. When the stricture etiology was unknown, or caused by catheter or instrumentation, the success rate was similar (from 65.2% to 73.3%) (table 5). It is probable that any kind of urethral stricture regardless of etiology loses its identity over time and becomes an identical pathological process, due to repeated treatment (dilation, urethrotomy, urethroplasty, multiple treatments), and the etiology of the original stricture no longer influences the outcome. Of patients with lichen sclerosus 36.7% required surgical revision of the perineal urethrostomy and in 7 (63.6%) recurrent stenosis was caused by a histologically proven involvement of the skin by lichen sclerosus. In our experience perineal urethrostomy was selected mainly for patients with panurethral strictures and the success rate according to stricture length showed no significant differences (tables 1
Table 6. Surgical revisions after perineal urethrostomy No. Revisions
No. Pts (%)
None 1 2 3 4 5
121 (69.9) 32 (18.5) 13 (7.5) 5 (2.9) 1 (0.6) 1 (0.6)
Total
173 (100)
and 5). With regard to the effects of previous urethroplasty on outcome the success rate was higher in patients who had not undergone previous treatment (73.2%) than in those who had undergone prior urethroplasty (67%) (table 3). Patients who had undergone prior 1-stage oral mucosa graft urethroplasty had a higher success rate (83.3%) compared to other groups (table 4). In our experience bulbar urethroplasty using 1-stage techniques showed a higher success rate (83.5%) compared to the present series of patients (70%).11,12 The main question arising from this study is why, in a large group of patients, we preferred to use a lower success rate technique (perineal urethrostomy) instead of a higher success rate technique (1-stage repair). There are 2 reasons in 2 different populations of patients. The first population of patients included those who informed us, “I underwent an innumerable number of prior failed operations. I am tired.” These words were usually from patients (mean age 53 years) who had undergone failed hypospadias repair (mean previous operations 4.5), or repeat failed urethroplasty (mean previous operations 4.1) or other conditions requir-
Table 5. Evaluation of various factors according to stricture etiology
No. pts (%) Median age (range) Mode stricture length No. success (%) No. failure (%) Median mos free of stricture Median mos followup (range) No. satisfaction: Dissatisfied Little satisfied Satisfied Very satisfied No. second stage urethroplasty (%): Yes No No. would undergo operation again (%): Yes No
Catheter
Infection
23 (13.3) 54 (23–72) Panurethral 15 (65.2) 8 (34.8) 30 45 (12–244)
3 (1.7) 47 (38–48) Panurethral 1 (33.3) 2 (66.7) 6 17 (12–103)
0 1 20 2
0 0 3 0
7 16
(30.4) (69.6)
3
22 1
(95.7) (4.3)
3
Failed Hypospadias 8 48
(4.6) (31–58) 3–4 cm 7 (87.5) 1 (12.5) 52.5 67 (15–118) 0 0 7 1
(100)
(100)
Lichen Sclerosus
Instrumentation
Unknown
Trauma
Overall
30 (17.3) 57 (34–85) Panurethral 19 (63.3) 11 (36.7) 45 90 (12–127)
15 (8.7) 55 (40–77) Panurethral 11 (73.3) 4 (26.7) 62 62 (14–142)
87 (50.3) 56 (27–28) Panurethral 64 (73.6) 23 (26.4) 39 62 (12–361)
7 (4.1) 55 (37–71) 3–4 cm 4 (57.2) 3 (42.8) 39 62 (21–125)
173 (100)
0 1 22 7
0 0 12 3
2 1 65 19
121 (70) 52 (30)
0 0 6 1
2 6
(25) (75)
8 22
(26.7) (73.3)
2 13
(13.3) (86.7)
24 63
(27.6) (72.4)
8
(100)
29 1
(96.7) (3.3)
15
(100)
84 3
(96.6) (3.4)
7
(100)
7
(100)
46 (26.6) 127 (73.4)
168 (97.1) 5 (2.9)
PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Table 9. Patient satisfaction according to age
Table 7. Patient replies to the questions included in the questionnaire
1. Has the perineal urethrostomy caused you any problems? Psychological problems Urination problems Sexual activity problems 2. Have you had problems with your partner due to this operation? Psychological problems Penetration problems Minor problems 3. Are you pleased with the results obtained with surgery? Dissatisfied A little satisfied Satisfied Very satisfied 4. How would you evaluate these results? Negative Fair/passable Good Excellent 5. Would you undergo this type of operation again? 6. Would you like to undergo second stage urethroplasty to restore normal urinary function?
No. Pt Age (%)
No. Yes (%)
No. No (%)
28 (16)
145 (84)
9 13 6 32
(32) (46) (22) (18)
141 (82)
11 (35) 13 (40) 8 (25)
2 (1.2) 3 (1.7) 135 (78) 33 (19.1) 3 (1.7) 4 (2.3) 121 (69.9) 45 (26.1) 168 (97.1)
5 (2.9)
46 (26.6)
127 (73.4)
ing periodic dilation or urethrotomy to avoid urinary retention. These patients were unable to accept the possibility of another complete failed urethroplasty. In our study 30% of patients required a new surgical revision of the perineal urethrostomy (table 6) and 28 (16%) investigated by questionnaire replied that perineal urethrostomy had caused psychological (32%), urination (46%) or sexual activity problems (22%) (table 7). But only 3 patients (1.7%) negatively evaluated the final result of surgery (table 7). Surprisingly the occurrence of some minor postoperative problems did not influence positive patient satisfaction and acceptance of this kind of surgery. These patients accepted this condition well because it is commonly known that the revision of urethrostomy is a quick and sure procedure with a 100% success rate. The majority of patients had a median time free of stricture longer than 3 years (table 5). Table 8. Patient satisfaction according to clinical outcome and median followup
Dissatisfied Little satisfied Satisfied Very satisfied Totals
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No. Pts (%)
No. Successes (%)
No. Failures (%)
Median Mos Followup (range)
2 (1.2) 3 (1.7) 135 (78) 33 (19.1)
1 (50) 1 (33.3) 93 (68.9) 26 (78.8)
1 (50) 2 (66.7) 42 (31.1) 7 (21.2)
59.5 (25–94) 96 (15–97) 61 (12–281) 77 (12–361)
173 (100)
121 (70)
52 (30)
Dissatisfied Little satisfied Satisfied Very satisfied Totals
No. Pts (%)
23–49 Yrs
50–69 Yrs
Older Than 70 Yrs
2 (1.2) 3 (1.7) 135 (78) 33 (19.1)
1 (50) 1 (33.3) 65 (48.2) 19 (57.6)
1 (50)
2 (66.7) 54 (40) 11 (33.3)
16 (11.8) 3 (9.1)
173 (100)
67 (38.7)
86 (49.7)
20 (11.6)
The second population of patients included those to whom the surgeon said, “I do not know which kind of urethroplasty is best to perform because I do not know the pathological status of your urethra.” These words were usually used for patients with aggressive stricture recurrence following repeat urethrotomy or prior end-to-end anastomosis, 2-stage repair, onlay graft procedure and those with an indwelling urethral stent in place. In these cases it is the pathological status of the urethra that conditions the surgical approach and not the technical expertise of the surgeon. The skilled urethral surgeon is likely able to perform a 1-stage repair in 99% of urethral stricture disease cases but we believe that some questions should be posed. It is it correct? Is it always correct to transplant an oral graft in ischemic or seriously damaged urethral tissue? Is it always correct to transect the urethra again in patients who have already undergone an end-to-end or augmented roof strip anastomosis showing urethral shortening? Is it always correct to perform 1-stage urethroplasty in patients with previous multiple failed treatment of urethral strictures that began 20 to 30 years ago and are showing multiple bladder diverticula or detrusor acontractility? Another question arising from this study regards patient satisfaction and acceptance of this kind of urinary diversion through perineal urethrostomy. The 1-stage repair provides restoration of micturition through a normal standing position and avoids patient discomfort caused by perineal urinary diversion that is often not accepted by the patient for religious, hygienic, cultural or psychological reasons. In our experience many patients in this population are already accustomed to seated voiding because of age and prior voiding difficulties. In contrast to complex 1-stage reconstruction, perineal urethrostomy is a minor surgical intervention and can be performed on an outpatient basis with an early return to normal activities.10 In older patients, or in those with multiple failed prior repairs, serious comorbidity, histologically severe disease or a severely scarred urethral plate we discussed the possibility of performing a temporary or definitive perineal urethrostomy with the patient. However, the final choice was selected on the basis of patient decision alone.10 The results
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of our questionnaire showed that 97.1% of patients were satisfied with the results obtained with surgery after a long followup period, as median patient age was 55 years at surgery and 60 (6 years later) at the investigation by questionnaire. Surprisingly patient satisfaction was not influenced by patient age because young patients (23 to 43 years old) were more satisfied than patients older than 70 years (table 9). Other previous and older studies of the literature revealed that some patients were satisfied with the results obtained with perineal urethrostomy and that one should not hesitate to conclude the treatment with the first stage.2,8,10 The final question arising from this study is why patients do not want to undergo the second stage of urethroplasty to obtain normal micturition in a standing position. In this series 26.6% of patients are on a waiting list for urethral closure, but when they are contacted to organize the second stage of urethroplasty they generally respond that while they recognize the excellent technical surgical expertise of their doctor, they prefer to wait because they believe that it will not restore the damaged urethra without a high risk of failure. The surgeon should respect these words because they are not a sign of inadequacy on the part of the surgeon but a sign of great humility and humanity essential to the character of anyone involved in restoring the integrity of the human body. We would stress that real success is the combination of the patient being free from recurrent stricture disease and satisfaction with their current situation, perineal urethrostomy, and not just freedom from stricture disease alone.
Figure 8 summarizes the algorithm for the management of urethral strictures. Finally we believe that our study might have a significant flaw as we used a nonvalidated questionnaire to investigate patient quality of life and satisfaction with surgery. Although we realized throughout our study that, to the best our knowledge, no specific Italian or English validated questionnaire exists, investigation of the patient perspective is worth pursuing. Recently the Food and Drug Administration, and European Medicines Agency pointed out the importance of patient reported outcomes, which are any outcomes evaluated directly by the patient, and are based on patient perception of the disease and its treatment.13,14 The lack of such a tool to evaluate the outcome of urethral reconstructive surgery forces us to create and use a questionnaire that, although nonvalidated, can measure important aspects of patient health status after perineostomy. This questionnaire was developed to cover single dimension and multidimensional measures of symptoms, health related quality of life, health status, adherence to treatment and satisfaction with perineostomy. We had already used a similar questionnaire approach in the assessment of end-to-end anastomosis.11 That questionnaire allowed us to understand the subjective outcomes, ie post-void dribbling or ejaculatory dysfunction, which were lost at our objective outcome measurement, ie urethrography.11 We believe that in the future it will be mandatory to develop specific questionnaires for urethral pathology on the basis of a clearly defined conceptual framework that indicates the importance of patient perspective or expectation.
Figure 8. Algorithm for management of anterior urethral strictures
PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
CONCLUSIONS Perineal urethrostomy is often a necessary procedure when dealing with complex urethral pathology.
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Patient satisfaction following this surgical procedure is high and quality of life is not negatively influenced.
REFERENCES 1. Russell RH: The treatment of urethral stricture by excision. Br J Surg 1914; 2: 375. 2. Johanson B: Reconstruction of the male urethra in strictures. Acta Chir Scand 1953; 176: 3. 3. Turner-Warwick RT: A technique for posterior urethroplasty. J Urol 1960; 83: 416. 4. Blandy JP, Singh M and Tresidder GC: Urethroplasty by scrotal flap for long urethral strictures. Br J Urol 1968; 40: 261. 5. Blandy JP: One-stage and two-stage urethroplasty. In: Reconstructive Urologic Surgery: Pediatric and Adult. Edited by JA Libertino and L Zinman. Baltimore: Williams & Wilkins Co 1977; chapt 24, pp 275-286. 6. Schreiter F: Mesh-graft urethroplasty: our experience with a new procedure. Eur Urol 1984; 10: 338.
7. Venn SN and Mundy AR: Urethroplasty for balanitis xerotica obliterans. Br J Urol 1998; 81: 735.
a single center experience. J Urol 2007; 178: 2470.
8. Secrest CL: Staged urethroplasty: indications and techniques. Urol Clin North Am 2002; 29: 467.
12. Barbagli G, Guazzoni G and Lazzeri M: One-stage bulbar urethroplasty: retrospective analysis of the results in 375 patients. Eur Urol 2008; 53: 828.
9. Peterson AC and Webster GD: Management of urethral stricture disease: developing options for surgical intervention. BJU Int 2004; 94: 971. 10. Peterson AC, Palminteri E, Lazzeri M et al: Heroic measures may not always be justified in extensive urethral stricture due to lichen sclerosus (balanitis xerotica obliterans). Urology 2004; 64: 565. 11. Barbagli G, De Angelis M, Romano G et al: Long-term followup of bulbar end-to-end anastomosis: a retrospective analysis of 153 patients in
13. Draft guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 2006; 71: 5862. 14. Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. Available at http://www.emea.europa.eu/pdfs/ human/ewp/1393104en.pdf.
Editor’s Note: This article is the third of 5 published in this issue for which category 1 CME credits can be earned. Instructions for obtaining credits are given with the questions on pages 808 and 809.
Purpose: We performed a quality of life assessment for patients treated with perineal urethrostomy for anterior urethral stricture disease. Materials and Methods: We retrospectively reviewed 173 patients (median age 55 years) who underwent perineal urethrostomy (from 1978 to 2007) as part of a plan for a staged urethroplasty repair for a complex anterior urethral stricture. The perineostomy was made using flap urethroplasty. The clinical outcome was considered a failure when postoperative instrumentation was needed. A questionnaire was used to evaluate patient quality of life and satisfaction. Results: Stricture etiology was unknown in 50.3% of the cases, lichen sclerosus in 17.3%, catheter in 13.3%, instrumentation in 8.7%, failed hypospadias repair in 4.6%, trauma in 4.1% and infection in 1.7%. Stricture length was 1 to less than 2 cm in 1.2% of cases, 2 to less than 3 cm in 3.5%, 3 to less than 4 cm in 12.1%, 4 to less than 5 cm in 13.8%, 5 to less than 6 cm in 7.5%, greater than 6 cm in 4.1% and panurethral in 57.8%. Of 173 patients 91 (52.6%) underwent prior urethroplasty. Median followup length was 62 months (range 12 to 361). Of 173 cases 121 (70%) were successful and 52 (30%) were failures, requiring revision of the perineostomy. Of 173 patients 135 (78%) were satisfied with the results obtained with surgery, 33 (19.1%) were very satisfied, 127 (73.4%) with a median age of 57 years (range 23 to 85) refused to do the second stage of urethroplasty and 46 (26.6%) with a median age of 47.5 years (range 27 to 72) are currently on a waiting list for the second stage of urethroplasty. Conclusions: Perineostomy is a necessary procedure for patients with complex urethral pathology and satisfaction rates are high. Key Words: urethra, urethral stricture, urinary diversion, surgical stomas
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STAGED urethroplasty represents an old form of urethral reconstruction. The surgical technique of marsupialization of the diseased urethra with delayed reconstruction was first described as early as 1914 by Russell.1 In 1953 the Swedish urologist Johanson widely refined and popularized the use of 2-stage techniques in reconstruction of the male urethra stricture, applying the principle of the buried strip
of intact epithelium previously described by Duplay, Marion and Denis Browne for hypospadias repair.2 Johanson’s technique was later refined by Turner-Warwick, who described a new 2-stage flap urethroplasty with regard to the more posterior stricture.3 TurnerWarwick’s technique was modified by Blandy because he found this operation exceedingly difficult to perform, having trouble with restenosis of the apex of
0022-5347/09/1822-0548/0 THE JOURNAL OF UROLOGY® Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 182, 548-557, August 2009 Printed in U.S.A. DOI:10.1016/j.juro.2009.04.012
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complex anterior urethral stricture diseases, in an observational descriptive study to define the clinical outcome, and patient quality of life and satisfaction.
MATERIALS AND METHODS
Figure 1. 艚-shaped perineal incision
the flap near the verumontanum. In 1968 he described the 艚-shaped scrotal flap urethroplasty which was much easier to perform and did not seem to result in recurrent stenosis.4,5 Later Blandy recounted the way in which he developed this surgical technique, believing then that it was original, but later confessed that this technique or something like it had already been described by Leadbetter, Gil-Vernet, Wells and Williams, and Crawford.5 Over time the standard 2-stage procedures were widely modified. In 1984 Schreiter described a new staged technique using a meshed split-thickness skin graft,6 and Venn and Mundy introduced the use of oral mucosal graft in staged procedures for patients with lichen sclerosus.7 In the era of the 1-stage repair there are still some indications for staged urethroplasty.8 –10 Strictures associated with local adverse conditions such as fistula, false passage, abscess, cancer or a prior unsuccessful complex urethroplasty are best treated with staged procedures.8,9 Another group of patients difficult to treat are those with lichen sclerosus urethral disease or those who have undergone complicated failed hypospadias repair.8–10 Perineal urethrostomy should be a temporary or definitive solution to a complex penile, bulbar or posterior urethral problem. Some patients choose not to have the urethra reconstructed in a second or third stage and continue to void through a perineal urethrostomy. Thus, the first stage becomes the only stage and a definitive procedure.8 We report our experience with 173 patients who underwent temporary or definitive perineal urethrostomy, using 艚-shaped scrotal flap urethroplasty, for
The study is a retrospective chart analysis of 173 patients who underwent perineal urethrostomy for anterior urethral stricture disease from June 1978 to June 2007 as part of a plan for a staged urethroplasty repair of a complex urethral stricture. Patients with posterior urethral strictures were excluded from the study. Preoperative evaluation included clinical history, physical examination, urine culture, residual urine measurement, uroflowmetry, and retrograde and voiding cystourethrography. Since 1998 urethral ultrasound was also performed on all patients. The patient is placed in a normal lithotomy position and a 艚-shaped perineal incision is made (fig. 1). The bulbar urethra is fully opened along its ventral surface and the margins of the spongiosum tissue are closed (fig. 2). The proximal urethral opening is inspected using a nasal speculum to see the verumontanum. The needle used for a 4-zero polyglactin suture is modified (fig. 3) and passed though the spongiosum tissue in front up to the verumontanum (fig. 4). Using this technique 3 stitches are passed
Figure 2. Urethra is ventrally opened and margins of spongiosum tissue are closed for hemostasis.
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PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Figure 3. Curve of needle (4-zero polyglactin suture) is modified into J shape.
in front up to the verumontanum and then into the apex of the 艚-shaped perineal skin flap (fig. 5). The stitches are tied, and the apex of the 艚-shaped perineal skin flap is pushed inside and sutured to the proximal urethral mucosa edge, in front up to the verumontanum (fig. 6). The perineal skin margins are sutured to the bulbar urethral plate margins and a 20Fr Foley catheter is left in place for 10 days (fig. 7). Patients were discharged from the hospital 3 to 5 days after surgery. Clinical outpatient examinations were scheduled at 3, 6 and 9 months postoperatively, and then annually. All patients underwent uroflowmetry with direct examination of the wide opening of the proximal perineal stoma by
Figure 5. Using this technique 3 stitches are passed in front up to verumontanum and then into apex of 艚-shaped perineal skin flap.
nasal speculum. The primary outcome measure was success (no evidence of stricture recurrence) or failure (evidence of stricture recurrence) rate according to age, etiology, stricture
Figure 4. Modified needle is passed though spongiosum tissue (A), tip of needle is retrieved in front up to verumontanum (B), advanced and then withdrawn (C), deeply penetrating into spongiosum body (D).
PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Figure 6. When 3 stitches are tied, apex of 艚-shaped flap is pushed in front up to verumontanum.
length and previous treatments. The surgery was considered a failure when any postoperative instrumentation was needed including dilation. Urine culture was repeated every 4 months in the first year and annually thereafter. When symptoms of decreased force of stream were present voiding urethrography and urethroscopy were repeated. The secondary outcome measure was patient satisfaction and acceptance of this urinary diversion (perineostomy), investigated using a nonvalidated questionnaire that was selfcompleted during the last followup visit. The questionnaire included 7 questions to investigate modifications in urinary function, sexual function and psychological impact, and 5 to evaluate final patient satisfaction or dissatisfaction after surgery. All patients who presented evidence of clinically severe cardiovascular, renal, hepatic, respiratory and neurological diseases, and any conditions that in the judgment of the investigators would interfere with the ability to fill out the questionnaire and to comply with study instructions, that would place the subject at increased risk or that might confound interpretation of study results, were ruled out.
RESULTS Median patient age at surgery was 55 years (range 23 to 85). Of the patients 67 (38.7%) were 23 to 49
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years old, 86 (49.7%) were 50 to 69 and 20 (11.6%) were older than 70 years. Median age according to stricture etiology is reported in table 1. Original stricture etiology was unknown in 87 (50.3%) cases, lichen sclerosus in 30 (17.3%), catheter in 23 (13.3%), instrumentation in 15 (8.7%), failed hypospadias repair in 8 (4.6%), trauma in 7 (4.1%) and infection in 3 (1.7%) (table 1). Stricture length was 1 to less than 2 cm in 2 patients (1.2%), 2 to less than 3 cm in 6 (3.5%), 3 to less than 4 cm in 21 (12.1%), 4 to less than 5 cm in 24 (13.8%), 5 to less than 6 cm in 13 (7.5%), greater than 6 cm in 7 (4.1%) and panurethral in 100 (57.8%) (table 1). Stricture length according to stricture etiology is reported in table 1. Median stricture length (mode) according to stricture etiology was panurethral, and only patients with failed hypospadias repair or traumatic strictures showed a median stricture length (mode) of 3 to 4 cm (table 1). Of 173 patients 150 (86.7%) underwent dilation (6.9%), urethrotomy (9.8%), urethroplasty (9.2%) or multiple treatments (dilation, urethrotomy and urethroplasty) (60.6%) (table 2). Of 173 patients 91 (52.6%) underwent prior failed urethroplasty, namely 8 (8.8%) failed hypospadias repair, 15 (16.5%) penile urethroplasty, 22 (24.1%) end-to-end anastomosis, 14 (15.4%) 1-stage skin graft urethroplasty, 6 (6.6%) 1-stage oral graft urethroplasty, 25 (27.5%) 2-stage repair and 1 (1.1%) 1-stage bladder mucosa graft urethroplasty (tables 3 and 4). In 24 patients (13.9%) a urethral stent was removed during the surgical procedure, and these patients had undergone a minimum of 1 operation and a maximum of 7 operations (mean 3.8) before our surgery. Patients with failed hypospadias repair underwent a minimum of 1 operation and a maximum of 10 operations (mean 4.5), while those with failed urethroplasty underwent a minimum of 1 operation and a maximum of 9 operations (mean 4.1). Of 173 patients 82 (47.4%) had not undergone prior urethroplasty and perineal urethrostomy was selected as the primary procedure (table 3). Median followup length was 62 months (range 12 to 361) (table 5). Patients with lichen sclerosus had a longer median followup (90 months) (table 5). Of 173 cases 121 (70%) were successes and 52 (30%) were failures (table 5). Based on patient age the success rate was 61.2% in men 23 to 49 years old (67 cases), 74.4% in those 50 to 69 years old (86) and 80% in men older than 70 years (20). Based on stricture etiology the success rate was 87.5% for cases of stricture following failed hypospadias repair (8 cases), 73.6% in strictures of unknown etiology (87), 73.3% for strictures following urethral instrumentation (15), 65.2% for strictures caused by a catheter (23), 63.3% for strictures caused by lichen sclerosus (30), 57.1% for traumatic strictures (7) and 33.3% for strictures following infection (3) (table 5). Based on stricture length the success rate was
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Figure 7. Perineal and scrotal skin margins are sutured to urethral margins (A–C), and 20Fr Foley catheter is left in place (D)
85.7% in patients with strictures greater than 6 cm (7 cases), 76.9% in those with 5 to less than 6 cm strictures (13), 71.4% in those with 3 to less than 4 cm strictures (21), 70.8% in those with 4 to less than 5 cm strictures (24), 68% in those with panurethral strictures (100), 66.7% in those with 2 to less than 3 cm strictures (6) and 50% in those with 1 to less than 2 cm strictures (2). Based on having received treatment before surgery the success rate was 75% in patients who underwent dilation (12), 73.9% in patients who had not undergone previous treatment (23), 64.7% in those who had undergone urethrotomy (17), 56.3% in those who had undergone prior urethroplasty (16) and 43.3% in those who had undergone multiple treatments (105) (table 2). In terms of having undergone urethroplasty before surgery the success rate was 73.2% in patients who had not undergone previous urethroplasty (82 cases) and 67% in those who had undergone prior failed urethroplasty (91) (table 3). Based on the type of prior failed repair the success rate
was 100% in patients who had undergone 1-stage bladder mucosa graft urethroplasty (1 case), 87.5% in those who had failed hypospadias repair (8), 83.3% for 1-stage oral graft urethroplasty (6), 68.2% for end-toend anastomosis (22), 64% for 2-stage repair (25), 60% for penile urethroplasty (15) and 57.1% in patients who had undergone 1-stage skin graft urethroplasty (14) (table 4). Of 173 cases 52 (30%) were treatment failures, requiring a new surgical revision of the proximal opening of the perineal urethrostomy. Of these 52 patients 32 (61.6%) required 1 surgical revision, 13 (25%) required 2, 5 (9.6%) required 3, 1 (1.9%) required 4 and 1 (1.9%) required 5 surgical revisions (table 6). Median time free of stricture according to stricture etiology was high in patients with strictures following instrumentation (62 months) or failed hypospadias repair (52.5 months) and low in those with strictures after infection (6 months) (table 5). All patients were able to reply to the 12 questions in the questionnaire. Median patient age at investi-
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Table 1. Etiology of stricture according to patient age and stricture length
No. pts (%) No. pt age (%): 23–49 50–69 Older than 70 Median pt age No. cm stricture (%): 1–2 2–3 3–4 4–5 5–6 Greater than 6 Panurethral Stricture mode
Catheter
Unknown
Infection
Failed Hypospadias
Lichen Sclerosus
Instrumentation
Trauma
Overall
23 (13.3)
87 (50.3)
3 (1.7)
8 (4.6)
30 (17.3)
15 (8.7)
7 (4.1)
173 (100)
9 (39.1) 11 (47.8) 3 (13.1) 54
36 (41.4) 43 (49.4) 8 (9.2) 56
3 (100)
5 (62.5) 3 (37.5)
6 (20) 20 (66.7) 4 (13.3) 57
5 (33.3) 8 (53.3) 2 (13.4) 55
3 (42.9) 1 (14.2) 3 (42.9) 51
67 (38.7) 86 (49.7) 20 (11.6)
2 (8.7) 3 (13) 3 (13) 4 (17.4) 1 (4.4) 10 (43.5) Panurethral
3 (3.5) 11 (12.6) 15 (17.3) 7 (8) 2 (2.3) 49 (56.3) Panurethral
47
48
3 (37.5) 1 (33.3)
2 (66.7) Panurethral
gation by questionnaire was 60 years (range 27 to 86). Of 173 patients who took the questionnaire 145 (84%) replied that the perineal urethrostomy did not cause any problems, and 28 (16%) replied that the perineal urethrostomy had caused psychological problems (32%), urination problems (46%) or sexual activity dysfunction (22%). A total of 141 patients (82%) replied that perineal urethrostomy did not cause any problems with the partner, and 32 (18%) replied that the perineal urethrostomy caused psychological problems (35%), penetration problems (40%) or minor problems (25%) in the relationship with the partner. Of 173 patients 135 (78%) were satisfied with the results obtained with surgery, 33 (19.1%) were very satisfied, 3 (1.7%) were a little satisfied and 2 (1.2%) were dissatisfied. A total of 121 patients (69.9%) considered the results to be good, 45 (26.1%) considered the results excellent, 4 (2.3%) found the results fair and 3 (1.7%) considered the results negative. When asked whether they would undergo this type of operation again 168 patients (97.1%) replied yes and 5 (2.9%) replied no. Patient responses to the questions are summarized in table 7. Of 173 patients 127 (73.4%) with a median age of 57 years (range 23 to 85) refused to undergo the second stage of urethroplasty to restore normal urinary function through the glanular meatus (table 5). Of 173 patients 46 (26.6%) with a median age of 47.5
1 (3.3) 2 (25) 2 (25) 1 (12.5) 3–4 cm
29 (96.7) Panurethral
1 (6.7) 2 (13.3) 2 (13.3) 2 (13.3) 8 (53.4) Panurethral
3 (42.8) 1 (14.3) 2 (28.6) 1 (14.3) 3–4 cm
2 (1.2) 6 (3.5) 21 (12.1) 24 (13.8) 13 (7.5) 7 (4.1) 100 (57.8)
years (range 27 to 72) are currently on a waiting list for the second stage of urethroplasty (table 5). Evaluation of patient satisfaction according to clinical outcome (success vs failure) and median followup is summarized in table 8, and evaluation of patient satisfaction according to patient age is summarized in table 9.
DISCUSSION We evaluated our results according to patient age, stricture etiology, length and prior treatments. In our experience patients younger than 50 years had a success rate of 61.2% and those older than 70 years had a success rate of 80% (table 1). In our previous experience age was not a factor in influencing the success rate of 1-stage bulbar urethroplasty and these results confirm that the use of perineal urethrostomy should not be withheld from patients on the basis of age.11,12 Evaluation of the success rate of the perineal urethrostomy according to stricture etiology demonstrated that the strictures showing a higher success rate (87.5%) were those that followed failed hypospadias repair and strictures showing a lower success rate were those that followed infection (33.3%) (but only 3 cases were recorded) or trauma (57.2%) (table 5). Usually in patients with failed hypospadias repair the bulbar urethra, where the perineal urethrostomy is made, was not involved in previous surgery, and this can explain the high success rate
Table 2. Success rate according to previous treatment Previous Treatment
No. Pts (%)
No. Successes (%)
No. Failures (%)
None Dilation Urethrotomy Urethroplasty Multiple treatments
23 (13.3) 12 (6.9) 17 (9.8) 16 (9.2) 105 (60.6)
17 (73.9) 9 (75) 11 (64.7) 9 (56.3) 75 (43.3)
6 (26.1) 3 (25) 6 (35.3) 7 (43.7) 30 (17.3)
173 (100)
121 (70)
52 (30)
Totals
Table 3. Success rate according to repair history Prior Urethroplasty
No. Pts (%)
No. Successes (%)
No. Failures (%)
None Prior failed urethroplasty
82 (47.4) 91 (52.6)
60 (73.2) 61 (67)
22 (26.8) 30 (33)
173 (100)
121 (70)
52 (30)
Totals
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PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Table 4. Success rate according the type of prior failed repair
Failed hypospadias repair Penile urethroplasty End-to-end anastomosis 1-Stage skin graft urethroplasty 1-Stage oral graft urethroplasty 2-Stage repair 1-Stage bladder mucosa graft urethroplasty Totals
No. Pts (%)
No. Successes (%)
No. Failures (%)
8 (8.8) 15 (16.5) 22 (24.1) 14 (15.4) 6 (6.6) 25 (27.5) 1 (1.1)
7 (87.5) 9 (60) 15 (68.2) 8 (57.1) 5 (83.3) 16 (64) 1 (100)
1 (12.5) 6 (40) 7 (31.8) 6 (42.9) 1 (16.7) 9 (36)
91 (52.6)
61 (67)
30 (33)
in these patients. Instead in patients with previous perineal trauma and stricture repair the urethral tract where the perineal urethrostomy is made is fully involved in the scarring process. When the stricture etiology was unknown, or caused by catheter or instrumentation, the success rate was similar (from 65.2% to 73.3%) (table 5). It is probable that any kind of urethral stricture regardless of etiology loses its identity over time and becomes an identical pathological process, due to repeated treatment (dilation, urethrotomy, urethroplasty, multiple treatments), and the etiology of the original stricture no longer influences the outcome. Of patients with lichen sclerosus 36.7% required surgical revision of the perineal urethrostomy and in 7 (63.6%) recurrent stenosis was caused by a histologically proven involvement of the skin by lichen sclerosus. In our experience perineal urethrostomy was selected mainly for patients with panurethral strictures and the success rate according to stricture length showed no significant differences (tables 1
Table 6. Surgical revisions after perineal urethrostomy No. Revisions
No. Pts (%)
None 1 2 3 4 5
121 (69.9) 32 (18.5) 13 (7.5) 5 (2.9) 1 (0.6) 1 (0.6)
Total
173 (100)
and 5). With regard to the effects of previous urethroplasty on outcome the success rate was higher in patients who had not undergone previous treatment (73.2%) than in those who had undergone prior urethroplasty (67%) (table 3). Patients who had undergone prior 1-stage oral mucosa graft urethroplasty had a higher success rate (83.3%) compared to other groups (table 4). In our experience bulbar urethroplasty using 1-stage techniques showed a higher success rate (83.5%) compared to the present series of patients (70%).11,12 The main question arising from this study is why, in a large group of patients, we preferred to use a lower success rate technique (perineal urethrostomy) instead of a higher success rate technique (1-stage repair). There are 2 reasons in 2 different populations of patients. The first population of patients included those who informed us, “I underwent an innumerable number of prior failed operations. I am tired.” These words were usually from patients (mean age 53 years) who had undergone failed hypospadias repair (mean previous operations 4.5), or repeat failed urethroplasty (mean previous operations 4.1) or other conditions requir-
Table 5. Evaluation of various factors according to stricture etiology
No. pts (%) Median age (range) Mode stricture length No. success (%) No. failure (%) Median mos free of stricture Median mos followup (range) No. satisfaction: Dissatisfied Little satisfied Satisfied Very satisfied No. second stage urethroplasty (%): Yes No No. would undergo operation again (%): Yes No
Catheter
Infection
23 (13.3) 54 (23–72) Panurethral 15 (65.2) 8 (34.8) 30 45 (12–244)
3 (1.7) 47 (38–48) Panurethral 1 (33.3) 2 (66.7) 6 17 (12–103)
0 1 20 2
0 0 3 0
7 16
(30.4) (69.6)
3
22 1
(95.7) (4.3)
3
Failed Hypospadias 8 48
(4.6) (31–58) 3–4 cm 7 (87.5) 1 (12.5) 52.5 67 (15–118) 0 0 7 1
(100)
(100)
Lichen Sclerosus
Instrumentation
Unknown
Trauma
Overall
30 (17.3) 57 (34–85) Panurethral 19 (63.3) 11 (36.7) 45 90 (12–127)
15 (8.7) 55 (40–77) Panurethral 11 (73.3) 4 (26.7) 62 62 (14–142)
87 (50.3) 56 (27–28) Panurethral 64 (73.6) 23 (26.4) 39 62 (12–361)
7 (4.1) 55 (37–71) 3–4 cm 4 (57.2) 3 (42.8) 39 62 (21–125)
173 (100)
0 1 22 7
0 0 12 3
2 1 65 19
121 (70) 52 (30)
0 0 6 1
2 6
(25) (75)
8 22
(26.7) (73.3)
2 13
(13.3) (86.7)
24 63
(27.6) (72.4)
8
(100)
29 1
(96.7) (3.3)
15
(100)
84 3
(96.6) (3.4)
7
(100)
7
(100)
46 (26.6) 127 (73.4)
168 (97.1) 5 (2.9)
PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
Table 9. Patient satisfaction according to age
Table 7. Patient replies to the questions included in the questionnaire
1. Has the perineal urethrostomy caused you any problems? Psychological problems Urination problems Sexual activity problems 2. Have you had problems with your partner due to this operation? Psychological problems Penetration problems Minor problems 3. Are you pleased with the results obtained with surgery? Dissatisfied A little satisfied Satisfied Very satisfied 4. How would you evaluate these results? Negative Fair/passable Good Excellent 5. Would you undergo this type of operation again? 6. Would you like to undergo second stage urethroplasty to restore normal urinary function?
No. Pt Age (%)
No. Yes (%)
No. No (%)
28 (16)
145 (84)
9 13 6 32
(32) (46) (22) (18)
141 (82)
11 (35) 13 (40) 8 (25)
2 (1.2) 3 (1.7) 135 (78) 33 (19.1) 3 (1.7) 4 (2.3) 121 (69.9) 45 (26.1) 168 (97.1)
5 (2.9)
46 (26.6)
127 (73.4)
ing periodic dilation or urethrotomy to avoid urinary retention. These patients were unable to accept the possibility of another complete failed urethroplasty. In our study 30% of patients required a new surgical revision of the perineal urethrostomy (table 6) and 28 (16%) investigated by questionnaire replied that perineal urethrostomy had caused psychological (32%), urination (46%) or sexual activity problems (22%) (table 7). But only 3 patients (1.7%) negatively evaluated the final result of surgery (table 7). Surprisingly the occurrence of some minor postoperative problems did not influence positive patient satisfaction and acceptance of this kind of surgery. These patients accepted this condition well because it is commonly known that the revision of urethrostomy is a quick and sure procedure with a 100% success rate. The majority of patients had a median time free of stricture longer than 3 years (table 5). Table 8. Patient satisfaction according to clinical outcome and median followup
Dissatisfied Little satisfied Satisfied Very satisfied Totals
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No. Pts (%)
No. Successes (%)
No. Failures (%)
Median Mos Followup (range)
2 (1.2) 3 (1.7) 135 (78) 33 (19.1)
1 (50) 1 (33.3) 93 (68.9) 26 (78.8)
1 (50) 2 (66.7) 42 (31.1) 7 (21.2)
59.5 (25–94) 96 (15–97) 61 (12–281) 77 (12–361)
173 (100)
121 (70)
52 (30)
Dissatisfied Little satisfied Satisfied Very satisfied Totals
No. Pts (%)
23–49 Yrs
50–69 Yrs
Older Than 70 Yrs
2 (1.2) 3 (1.7) 135 (78) 33 (19.1)
1 (50) 1 (33.3) 65 (48.2) 19 (57.6)
1 (50)
2 (66.7) 54 (40) 11 (33.3)
16 (11.8) 3 (9.1)
173 (100)
67 (38.7)
86 (49.7)
20 (11.6)
The second population of patients included those to whom the surgeon said, “I do not know which kind of urethroplasty is best to perform because I do not know the pathological status of your urethra.” These words were usually used for patients with aggressive stricture recurrence following repeat urethrotomy or prior end-to-end anastomosis, 2-stage repair, onlay graft procedure and those with an indwelling urethral stent in place. In these cases it is the pathological status of the urethra that conditions the surgical approach and not the technical expertise of the surgeon. The skilled urethral surgeon is likely able to perform a 1-stage repair in 99% of urethral stricture disease cases but we believe that some questions should be posed. It is it correct? Is it always correct to transplant an oral graft in ischemic or seriously damaged urethral tissue? Is it always correct to transect the urethra again in patients who have already undergone an end-to-end or augmented roof strip anastomosis showing urethral shortening? Is it always correct to perform 1-stage urethroplasty in patients with previous multiple failed treatment of urethral strictures that began 20 to 30 years ago and are showing multiple bladder diverticula or detrusor acontractility? Another question arising from this study regards patient satisfaction and acceptance of this kind of urinary diversion through perineal urethrostomy. The 1-stage repair provides restoration of micturition through a normal standing position and avoids patient discomfort caused by perineal urinary diversion that is often not accepted by the patient for religious, hygienic, cultural or psychological reasons. In our experience many patients in this population are already accustomed to seated voiding because of age and prior voiding difficulties. In contrast to complex 1-stage reconstruction, perineal urethrostomy is a minor surgical intervention and can be performed on an outpatient basis with an early return to normal activities.10 In older patients, or in those with multiple failed prior repairs, serious comorbidity, histologically severe disease or a severely scarred urethral plate we discussed the possibility of performing a temporary or definitive perineal urethrostomy with the patient. However, the final choice was selected on the basis of patient decision alone.10 The results
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PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
of our questionnaire showed that 97.1% of patients were satisfied with the results obtained with surgery after a long followup period, as median patient age was 55 years at surgery and 60 (6 years later) at the investigation by questionnaire. Surprisingly patient satisfaction was not influenced by patient age because young patients (23 to 43 years old) were more satisfied than patients older than 70 years (table 9). Other previous and older studies of the literature revealed that some patients were satisfied with the results obtained with perineal urethrostomy and that one should not hesitate to conclude the treatment with the first stage.2,8,10 The final question arising from this study is why patients do not want to undergo the second stage of urethroplasty to obtain normal micturition in a standing position. In this series 26.6% of patients are on a waiting list for urethral closure, but when they are contacted to organize the second stage of urethroplasty they generally respond that while they recognize the excellent technical surgical expertise of their doctor, they prefer to wait because they believe that it will not restore the damaged urethra without a high risk of failure. The surgeon should respect these words because they are not a sign of inadequacy on the part of the surgeon but a sign of great humility and humanity essential to the character of anyone involved in restoring the integrity of the human body. We would stress that real success is the combination of the patient being free from recurrent stricture disease and satisfaction with their current situation, perineal urethrostomy, and not just freedom from stricture disease alone.
Figure 8 summarizes the algorithm for the management of urethral strictures. Finally we believe that our study might have a significant flaw as we used a nonvalidated questionnaire to investigate patient quality of life and satisfaction with surgery. Although we realized throughout our study that, to the best our knowledge, no specific Italian or English validated questionnaire exists, investigation of the patient perspective is worth pursuing. Recently the Food and Drug Administration, and European Medicines Agency pointed out the importance of patient reported outcomes, which are any outcomes evaluated directly by the patient, and are based on patient perception of the disease and its treatment.13,14 The lack of such a tool to evaluate the outcome of urethral reconstructive surgery forces us to create and use a questionnaire that, although nonvalidated, can measure important aspects of patient health status after perineostomy. This questionnaire was developed to cover single dimension and multidimensional measures of symptoms, health related quality of life, health status, adherence to treatment and satisfaction with perineostomy. We had already used a similar questionnaire approach in the assessment of end-to-end anastomosis.11 That questionnaire allowed us to understand the subjective outcomes, ie post-void dribbling or ejaculatory dysfunction, which were lost at our objective outcome measurement, ie urethrography.11 We believe that in the future it will be mandatory to develop specific questionnaires for urethral pathology on the basis of a clearly defined conceptual framework that indicates the importance of patient perspective or expectation.
Figure 8. Algorithm for management of anterior urethral strictures
PERINEAL URETHROSTOMY FOR ANTERIOR URETHRAL STRICTURE DISEASE
CONCLUSIONS Perineal urethrostomy is often a necessary procedure when dealing with complex urethral pathology.
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Patient satisfaction following this surgical procedure is high and quality of life is not negatively influenced.
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a single center experience. J Urol 2007; 178: 2470.
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9. Peterson AC and Webster GD: Management of urethral stricture disease: developing options for surgical intervention. BJU Int 2004; 94: 971. 10. Peterson AC, Palminteri E, Lazzeri M et al: Heroic measures may not always be justified in extensive urethral stricture due to lichen sclerosus (balanitis xerotica obliterans). Urology 2004; 64: 565. 11. Barbagli G, De Angelis M, Romano G et al: Long-term followup of bulbar end-to-end anastomosis: a retrospective analysis of 153 patients in
13. Draft guidance for industry on patient-reported outcome measures: use in medical product development to support labeling claims. Fed Regist 2006; 71: 5862. 14. Committee for Medicinal Products for Human Use. Reflection paper on the regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products. Available at http://www.emea.europa.eu/pdfs/ human/ewp/1393104en.pdf.