Received: 4 December 2016

| Revised: 12 January 2017

| Accepted: 18 January 2017

DOI 10.1002/nau.23243

ORIGINAL CLINICAL ARTICLE

Turkish validation of the urethral stricture surgery specific

patient-reported outcome measure (USS-PROM) with
supplemental assessment of erectile function and morbidity due
to oral graft harvesting

Fikret Fatih Önol1 | Ahmet Bindayi2 | Ahmet Tahra2 |

Ismail Basibuyuk1 | Sinasi Yavuz Onol1
1 Onol Urology, Istanbul, Turkey
2 Department
AIMS: We validated a Turkish language version of the urethral stricture surgery
of Urology, Umraniye Training and
Research Hospital, Istanbul, Turkey specific patient-reported outcome measure (USS-PROM) in men undergoing
Correspondence anterior urethroplasty. We also investigated changes in erectile function (EF) and
Fikret Fatih Önol, MD, FEBU Onol Urology, quality of life (QoL) due to oral mucosa graft (OMG) harvesting.
Halaskargazi cd. No. 183/3 D.6 (34371), Istanbul,
METHODS: The USS-PROM captures lower urinary tract symptoms (LUTS),
Turkey.
Email: ffonol@yahoo.com
health related QoL (HRQoL) with EQ-5D visual analogue scale (EQ-VAS). To
evaluate EF and OMG morbidity, we used International Index of Erectile Function
(IIEF-5) and a self-completed questionnaire, respectively. Psychometric assess-
ment of USS-PROM included test-retest reliability, internal consistency, criterion
validity, and responsiveness. Objective evidence for urethroplasty success was
demonstrated with fluoroscopic imaging and urethral calibration at post-operative
six months.
RESULTS: Among the 101 men included during study period, 42 had complete pre-
and postoperative 6th month data for analysis. The test-retest intraclass correlation
was 0.79. Cronbach's α for internal consistency of the LUTS construct was 0.79.
There was a significant negative correlation between total LUTS scores and peak
flow rates, both preoperatively (r = −0.478) and postoperatively (r = −0.508).
Mean baseline EQ-VAS increased from 70 to 84 postoperatively (P < 0.001),
indicating improved HRQoL. IIEF scores did not change significantly after
urethroplasty. Early and late-term QoL impairment rates due to OMG harvesting
were 28.9 and 13.1%, respectively. Three (7.1%) men required endoscopic
intervention for recurrence within 6 months.
CONCLUSIONS: Turkish version of USS-PROM showed comparable psychomet-
ric properties with the original version. Complementation of this instrument with
additional measures that address sexual function and OMG morbidity provides
better QoL assessment for urethral reconstruction.

KEYWORDS
patient-reported outcomes measures, quality of life, urethroplasty

1 | INTRODUCTION

Hashim Hashim led the peer-review process as the Associate Editor responsible for Urethroplasty is the gold standard treatment for patients with
the paper. urethral stricture disease.1 Authors have used different

Neurourology and Urodynamics. 2017;9999:1–7 wileyonlinelibrary.com/journal/nau © 2017 Wiley Periodicals, Inc. | 1

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| ÖNOL
criteria to define success based on fluroscopy, uroflowmetry,
and cystoscopy, which makes it difficult to compare
urethroplasty outcomes reported worldwide.2 Patient-
reported outcome measures (PROMs) on subjective voiding
symptoms, pain, mobility, and health-related quality of life
(HRQoL) are equally important as objective measures for
effective reporting of urethroplasty outcomes.3,4
Currently, only one specific PROM exists for the
measurement of patient-perceived benefits from male
urethroplasty.3 Utilization of this urethral stricture specific
PROM (“USS-PROM”) among urologists provides better
pre-operative patient counseling and measurement of health-
care benefits from urethroplasty, and setting global standards
for data collection for comparison among different healthcare
systems.3,4 We conducted this study to validate a Turkish
language version of the USS-PROM in men undergoing
urethroplasty. We also investigated changes in erectile
function and morbidity due to oral graft harvesting which
were not addressed by the current USS-PROM, but have a
strong potential to influence QoL in the context of urethral
reconstruction.
2 | PATIENTS AND METHODS
Following institutional ethics committee approval, all men
scheduled for anterior urethroplasty between 2013 and 2015
in our clinic were invited to participate in this prospective
study. Patients undergoing a staged procedure or a definitive
perineal urethrostomy, and those with a history of hypospa-
dias repair were excluded from the study.
Clinical evaluation included medical history, assessment
of symptoms with USS-PROM, uroflowmetry with measure-
ment of post-void residual (PVR) urine volume, and
combined retrograde urethrography (RU)/voiding cystour-
ethrography (VCUG) preoperatively and six months after
surgery. USS-PROM was complemented by International
Index of Erectile Function (IIEF-5) questionnaire to assess
changes in sexual function with urethroplasty.5 Graft donor
site morbidity was evaluated using a self-completed
questionnaire adapted from Barbagli et al6 This semi-
quantitative tool measures immediate post-operative QoL
through severity assessment of pain, edema, bleeding, and
ability to feed within 7 days of surgery, and measures late-
term QoL based on evaluation of numbness, sensory changes,
difficulty with mouth opening and smiling.6
2.1 | USS-PROM
The USS-PROM consists of four main constructs: lower
urinary tract symptoms (LUTS) and LUTS-related
quality-of-life (QoL) domain, Peeling's voiding picture,
EuroQoL dimensional scale (EQ-5D), and post-operative
overall patient satisfaction questions.3 LUTS domain consists
ET AL.
of six questions to generate a total score between 0
(asymptomatic) and 24 (most symptomatic), and a separate
LUTS-related QoL question which are derived from
International Consultation on Incontinence Questionnaire
Male Lower Urinary Tract Symptoms (ICIQ-MLUTS)
module.7 Peeling's voiding picture question addresses
strength of urinary stream.8 EQ-5D addresses mobility,
self-care, usual activities, pain/discomfort, and anxiety.9
Overall health related quality of life (HRQoL) is assessed by
EQ-5D visual analogue scale (EQ-VAS) where point 100
represents “best imaginable” and point 0 shows “worst
imaginable” health state.
2.2 | Psychometric evaluation of USS-PROM
2.2.1 | Translation
The original English version of USS-PROM was translated
into Turkish, then re-translated into English as described
previously.10,11 Finally, each question was rendered in its
most comprehensible form by a committee of four people that
consisted of two urologists fluent in English, a Turkish
linguist, and an English linguist.
2.2.2 | Test-retest reliability
Test-retest reliability documents the translated USS-PROM's
stability and reproducibility over time.3 Thirty-two men
completed the USS-PROM twice preoperatively with two
weeks apart, so that disease progression or possible emergency
intervention was unlikely to interfere with the assessment.
Agreement was evaluated using intraclass correlation coef-
ficients (ICCs) and kappa value. Predefined accepted threshold
value of ICC was minimum 0.70 for inclusion.12
2.2.3 | Internal consistency
Internal consistency characterizes the extent to which
question items within the same construct measure the same
conceptual domain and demonstrates whether it is valid to
sum those item scores.3,12 Cronbach's α statistics and item-
total correlations were used to assess the interrelationship
between question items within the LUTS construct. A
Cronbach's α value of >0.70 was regarded as acceptable.13
2.2.4 | Validity
Validity shows the degree to which the content of USS-
PROM covers the conceptual domain it intends to measure.
Content validity was assessed by correlating LUTS construct
scores with maximum flow rate (Qmax) on uroflowmetry and
overall patient satisfaction.3
2.2.5 | Responsiveness
Responsiveness was evaluated by examining LUTS, HRQoL,
and Peeling's voiding picture scores, as well as IIEF-5 scores
ÖNOL ET AL.
for statistically significant changes before and 6 months after
urethroplasty using the paired Student's t test.3,11
2.3 | Post-operative assessment
Objective success was defined as demonstration of urethral
patency on post-operative RU/VCUG and the ability to
advance a 16/18 Fr catheter through the reconstructed urethra
without any pressure at 6th month. Donor site related QoL
was considered low if oral graft harvesting morbidity score
was >7 at post-operative 1st week and >10 at 6th month
follow-up, in accordance with the cutoff values described by
Barbagli et al.6
3 | RESULTS
A total of 101 male anterior urethroplasties were performed
by two surgeons (F.F.O and S.Y.O) during the study period.
Forty-two of them had complete pre- and post-operative 6th
month data and were included in the final analysis. Of these
patients, 9 (21.4%) had penile (including isolated fossa
navicularis strictures), 23 (55%) had bulbar, 6 (14.3%) had
panuretral, and 4 (9.5%) had multiple (≥2) anterior urethral
strictures. Prior to surgery, 12 (28.5%) men had a suprapubic
cystostomy. Four (10%) men underwent anastomotic and 38
(90%) received oral mucosa graft urethroplasty. Harvest site
was left open to heal secondarily in all patients with oral graft
urethroplasty. Clinical information for patients are summa-
rized in Table 1.
3.1 | Psychometric evaluation
3.1.1 | Test-retest reliability
ICCs ranged from 0.60 to 0.83 for each of the USS-PROM
LUTS question items (Table 2) and 0.79 (95% confidence
interval [CI], 0.63-0.89) for the total scores, which exceeded
our predefined threshold of 0.70. LUTS related QoL Kappa
value was 81.4% (P < 0.01) (Table 3).
3.1.2 | Internal consistency
In the USS-PROM total LUTS score, Cronbach's α was
0.79 and ranged from 0.67 to 0.78 with any one item
deleted. Item-total correlations were similarly high: Pearson
correlation coefficients between any one item and the total
score of the remaining items ranged from 0.41 to 0.82
(Table 2).
3.1.3 | Validity
There was a significant negative correlation between total
LUTS scores and Qmax values, both preoperatively and 6
months postoperatively (Fig. 1a and b: r = −0.478,
| 3
P = 0.004 and r = −0.508, P = 0.003, respectively). Seven-
teen of 42 men (40.5%) were asymptomatic for LUTS
(score 0) at post-operative 6 months while 50% felt their
residual voiding symptoms interfered a little or not at all
with their QoL. Thirty-nine (92.8%) patients reported being
satisfied or very satisfied with the outcome of their
operation.
3.1.4 | Responsiveness
Mean total LUTS construct score decreased from 16 ± 5.6
preoperatively to 5.6 ± 5.9 postoperatively (P < 0.001; 95%
CI, 3.4-12.4). Also, mean pre-operative LUTS-related QoL
score decreased from 2.42 to 0.83 postoperatively (P < 0.001;
Table 4). Urinary stream force on Peeling's picture improved
in a similar pattern (mean score 3.17 preoperatively vs. 1.33
postoperatively, P < 0.001; Table 4). EQ-5D visual analog
scores significantly increased from a mean baseline value of
70-84 after urethroplasty (P < 0.001; Table 4).
3.2 | Change in sexual function
Thirty-four (80.9%) men were sexually active before surgery.
Mean IIEF-5 scores at post-operative 6 months were not
significantly different from pre-operative values (16 ± 6.9 vs.
14. ± 7.6, P = 0.07).
3.3 | QoL after oral graft harvesting
Based on pre-determined cutoff values, 11 (28.9%) and 5
(13.1%) men had early (within post-operative 7 days) and
late (post-operative 6th month) QoL impairment due to oral
graft harvesting. Early morbidity rates for buccal, lower lip,
and buccal involving lower lip graft harvesting were 20,
30, and 50%, respectively. Late morbidity rates were 10, 10,
and 25% with respect to harvest technique. Pain in the
harvest site was the most common complaint during early
assessment, whereas oral numbness and difficulty with
opening the mouth were the most common complications in
the late term. Nevertheless, 35 (92.1) men reported that they
would undergo graft harvesting using the same procedure
again.
3.4 | Objective urethroplasty success
Mean baseline (Qmax) significantly increased from
4.5 ± 3.5 mL/s to 22.3 ± 10.6 mL/s at post-operative 6
months (P < 0.001). Mean PVR decreased from
183.5 ± 167.9 mL to 34.7 ± 18.4 mL (P = 0.001). Based on
our strict anatomical criteria, eight (19%) men demonstrated
signs of urethral narrowing at post-operative 6th month
evaluation. Three (7.1%) men required endoscopic interven-
tion within 6 months and were regarded as failures. In the
remaining five men, Qmax was >15 mL/s with a good flow
curve in all but one patient.
4
| ÖNOL ET AL.

TABLE 1 Clinical characteristics of 42 men in the study cohort (values are 3.5 | Post-operative complications
presented as mean ± standard deviation [and range] or number of cases [and
percent]) Incidence of surgical complications within 30 days of
Age, years 59.9 ± 12.1 (22-81)
urethroplasty was 14.2%. Three men had Clavien-Dindo14
grade 1 complication (scrotal/perineal hematoma or mild
Body Mass Index, kg/m2 25.8 ± 1.9 (22-31)
wound dehiscence), one had grade 2 (wound infection that
Disease duration, months 56.5 ± 87.9 (3-258)
required parenteral antibiotics), and two had grade 3a
Number of interventions before surgery 5.2 ± 5.2 (0-24)
complications (penoscrotal abscess that required drainage
Time between last intervention and surgery, 10.4 ± 12.1 (0-48)
under local anesthesia). No serious (grades 4 and 5)
months
complications were encountered.
Stricture etiology
Iatrogenic 20 (47.6)
Idiopathic 5 (11.9)
Cardiac by-pass surgery 2 (4.8) 4 | DISCUSSION
Trauma 4 (9.5)
USS-PROM represents the only validated tool to measure
Lichen sclerosus 7 (16.7)
patient-perceived success and assess HRQoL specific for
Urethritis 2 (4.8)
urethral stricture surgery.3 To date, USS-PROM was
Urethral stone 2 (4.8)
validated to Italian, German, Russian, and Spanish lan-
Stricture length, mm 56 ± 53.9 (10-190)
guages11,15–17, and proves as a valid and reliable tool that
Stricture location enables standardized data reporting. For the first time, we
Meatus/Fossa Navicularis 2 (4.8) have demonstrated that Turkish version of USS-PROM is
Penile urethra 7 (16.7) also reliable and consistent for assessing subjective outcomes
Bulbar urethra 18 (42.9) after male anterior urethroplasty.
Bulbomembranous urethra 5 (11.9) LUTS construct scores showed a significant correlation
Multiple strictures 4 (9.5) with pre- and post-operative Qmax values, demonstrating
Panurethral 6 (14.3) validity of Turkish version of USS-PROM. Improvement in
Operative time, min 147.7 ± 50.2 (40-
Qmax was in accordance with the significant improvement in
300) urinary stream scores on Peeling's voiding picture. There was
Operation type a significant increase in the EQ-5D VAS score at post-
Dorsal graft inlay 12 (28.6) operative 6 months, indicating improved HRQoL following
Ventral graft onlay 11 (26.2)
urethroplasty. In this way, we have shown that USS-PROM is
suitable for wider use and facilitates direct comparisons of
Combined ventral onlay and dorsal inlay 15 (35.7)
data with other healthcare systems that use different language
Anastomotic 4 (9.5)
versions of this instrument. This is particularly important,
Harvested graft length, mm 71.3 ± 50.7 (20-195)
considering the variable patient characteristics, the wide
Graft harvest site
range of procedures performed, as well as costs and
Buccal mucosa (single cheek) 20 (52.6)
difficulties associated with conducting randomized trials in
Lower lip mucosa 10 (26,3) urethral stricture disease.
Buccal and lower lip (single long piece) 8 (25) Present results were in line with Barbagli et al16 and Kluth
et al11 who were the first to validate USS-PROM in Italian
and German, respectively. However, only Kluth et al
evaluated additional healthcare measures, such as erectile
TABLE 2 Reliability statistics for USS-PROM lower urinary tract function and urinary incontinence.11 In this study, we have
symptoms (LUTS) construct questions
further investigated QoL due to oral graft harvesting in
ICC (test- Corrected item-total Cronbach's α with
addition to assessment of changes in erectile function.
Q retest) correlation item deleted
Anxiety regarding future erectile function is a frequent
1 0.70* 0.45 0.78
concern for men undergoing urethroplasty. Our data revealed
2 0.60* 0.52 0.76
no significant change in IIEF-5 scores following male
3 0.78* 0.55 0.75
anterior urethroplasty. This is in contrast to the report by
4 0.83* 0.82 0.67 Kluth et al, who investigated erectile changes following one-
5 0.73* 0.51 0.78 stage buccal mucosa graft in a similar cohort. They reported a
6 0.80* 0.41 0.78 significant increase in mean baseline IIEF scores from 12.7 to
Q, question; ICC, intraclass correlation coefficient.
15.2 at post-operative 3 months. However, the significance of
*P < 0.01. this increase is unclear since both scores fall to the same IIEF
ÖNOL ET AL.
TABLE 3 Reliability statistics for USS-PROM lower urinary tract symptoms (LUTS)-related quality of life question
None A little
Preop. 1, n (%) 0 (0) 2 (6)
Preop. 2, n (%) 0 (0) 2 (6)
Data derived from 32 men who completed USS-PROM twice before urethroplasty
* P < 0.01.
category.5 Reports of improved erectile function following
urethroplasty are possibly related to increased psychological
well-being and overall QoL as a consequence of successful
treatment. Our results were otherwise supported by most
previous studies.4,18
A limitation of our study is that we did not investigate
other components of sexual function, such as changes in
ejaculatory satisfaction and glans sensation. Literature data
on these measures is scarce and contradictory. Barbagli et al
reported 23% incidence of ejaculatory problems and 18%
incidence of diminished glans sensitivity through a telephone
survey in 60 men that underwent anastomotic bulbar
urethroplasty.19 In contrast, Palminteri et al reported
improved ejaculation in 65% and improved sexual desire in
69% of 50 men who received ventral graft bulbar
urethroplasty, based on their assessment of Male Sexual
Health Questionnaire-Long Form and unvalidated Post-
Urethroplasty Sexual Questionnaire.20 Only two patients
(4%) in their series felt their glans cold during post-operative
erections. There is a need to develop specific PROMs that will
clarify the effects of urethroplasty on all domains of sexual
function.
Oral graft harvesting in our study caused impaired QoL in
28.9 and 13.1% of men in the early and late post-operative
period, respectively, which underscores the need for
implementation of USS-PROM with tools that assess graft-
related QoL. The major early morbidity source was pain and
F I G UR E 1 Scatter plots demonstrating relation between LUTS construct scores of the USS-PROM and peak urinary flow rates (Qmax) on
uroflowmetry. A significant negative correlation exists between total LUTS scores and Qmax values, both preoperatively (a: r = −0.478, P = 0.004) and 6
months postoperatively (b: r = −0.508, P = 0.003)
| 5
Somewhat A lot Kappa value
8 (25) 22 (69) 0.814*
8 (25) 22 (69)
major long-term concerns were oral numbness and difficulty
with opening the mouth, which are in accordance with other
reports.21,22 Although immediate post-operative QoL was in
favor of buccal as compared to lower lip and buccal including
lower lip harvesting, long-term satisfaction rates were
equivalent among these three techniques. In a similar cohort,
Jang et al reported that early post-operative discomfort as
measured by visual analog pain scale was not significantly
different between these three harvest techniques.21 However,
they closed all mucosal defects unlike our practice. Thus, it is
difficult to reliably compare literature data owing to the
significant variation in symptoms assessment, harvest
location, graft configuration, and practice to close the donor
site.
The scope of PROMs is to subjectively measure benefits
perceived by patients from urethroplasty, but it is also
important to document objective evidence for success. Using
a 17 Fr flexible cystoscope, DeLong et al18 and Tam et al23
reported stricture recurrence rates of 6 and 13.7% at 6 months,
respectively. While cystoscopy enables direct visualization of
the entire urethra, it is more costly than a urethrogram and
may not distinguish stricture recurrence at the site of repair
from a new stricture at a differing location if used alone.23,24
We use post-operative cystoscopy only if follow-up findings
suggest a clinically relevant re-stenosis. Our general practice
is to compare pre- and post-operative urethrograms in
addition to a urethral calibration at post-operative 6 months.
6
| ÖNOL ET AL.

TABLE 4 Responsiveness statistics for USS-PROM constructs and erectile function that generate a numerical score
Construct Item Pre-operative mean Post-operative mean at 6 mo.s P 95%CI mean of differences
LUTS
Q1 2.30 1 0.07 −0.13-2.73
Q2 3.40 0.70 <0.001 1.39-4.01
Q3 2.50 0.80 <0.001 0.58-2.82
Q4 2.50 1 <0.001 0.42-2.58
Q5 2.20 1.30 <0.001 −0.90-2.70
Q6 1.70 1 0.173 −0.37-1.77
LUTS-related QoL Q7 2.42 0.83 <0.001 1.10-2.09
Peeling's picture Q8 3.17 1.33 <0.001 1.13-2.54
EQ5D TTO 0.89 0.92 0.04 −0.11-0.06
EQVAS 70 84 <0.001 14-21
IIEF-5 17.3 15.2 0.174 1.71-8.38

Q, question; CI, confidence interval; LUTS, lower urinary tract symptoms; QoL, quality of life; TTO, time trade-off; IIEF, International Index of Erectile Function
Questionnaire.

Using our strict criteria, 8 (19%) men had signs of urethral
narrowing at 6 months. Three of them required endoscopic
intervention, whereas five men maintained good flow rates in
serial uroflowmetry studies with up to three years follow-up.
It is currently unclear what percent of these strictures will
progress to a clinically significant one that interferes with the
patient's QoL.
This study has certain limitations. First, the relatively
small sample size (n = 42) may have influenced the
reliability statistics of our study. Terwee et al recom-
mended at least 100 subjects to ensure internal consis-
tency.12 However, Cronbach's α was 0.79 for the LUTS
construct of USS-PROM, which is greater than the
minimum recommended value of 0.70.13 Notably, none
of the similar studies recruited such a high number of
patients and all reported Cronbach's α values that ranged
between 0.70 and 0.83.15–17 Second, our cohort included a
variety of strictures that ranged from short navicular fossa
strictures to long panurethral strictures treated with
different reconstructive techniques, making it difficult to
ascertain our results in specific patient subgroups.
In conclusion, Turkish version of USS-PROM showed
comparable psychometric properties with previous valida-
tion studies and the original one. This instrument can be
reliably utilized in different healthcare systems and in
patient populations with different cultures and languages.
However, there is a need for broader complementation of
this tool with novel PROMs that will address all domains of
sexual function, QoL associated with oral graft harvesting,
and concerns for cosmesis in distal urethral reconstruction.
Further work should also focus on testing of these
instruments in specific patient subgroups so that a reliable
comparison can be performed between different operative
techniques.
POTENTIAL CONFLICT OF
INTEREST:
Nothing to disclose.
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How to cite this article: Önol FF, Bindayi A,
Tahra A, Basibuyuk I, Onol SY. Turkish validation
of the urethral stricture surgery specific patient-
reported outcome measure (USS-PROM) with
supplemental assessment of erectile function and
morbidity due to oral graft harvesting. Neurourology
and Urodynamics. 2017;9999:1–7.