Title

954 Validation of a patient-reported outcome measure (PROM) for urethral stricture surgery: A
prospective study at a German tertiary care center

Eur Urol Suppl 2015;14/2;e954           Print!

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Kluth L.A., Dahlem R., Becker A., Schmid M., Soave A., Rosenbaum C., Ludwig T.A., Rink M., Reiss P., Engel O., Riechardt S., Chun
F.K.H., Fisch M., Ahyai S.A.

University Medical Center Hamburg-Eppendorf, Dept. of Urology, Hamburg, Germany

INTRODUCTION & OBJECTIVES: Jackson et al. previously validated a patient-reported outcome measure (PROM) assessing both voiding
symptoms and health related quality of life (HRQoL) following urethral stricture surgery (USS). However, this tool lacks evaluation of urinary
incontinence and erectile function. We aimed to prospectively validate the USS-PROM in a homogenous cohort of patients undergoing
buccal mucosa graft urethroplasty (BMGU) for urethral stricture disease at a German tertiary care center.

MATERIAL & METHODS: This was an institutional review board approved study. First, the USS-PROM was translated into German and
retranslated into English. We included the International Consultation on Incontinence Questionnaire - Urinary Incontinence (ICIQ-UI SF) and
the International Index of Erectile Function (IIEF-5) to evaluate urinary incontinence and erectile function, respectively. Between 01/2012
and 05/2013, 187 patients underwent one-stage BMGU for urethral stricture disease at our institution. Psychometric assessment included
responsiveness, internal consistency, test-retest reliability, and criterion validity. Participants self-completed USS-PROM before, 3 months
and 6 months after surgery.

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RESULTS: A total of 93 men agreed and were enrolled in this study, thus completed the USS-PROM before and 3 months after surgery.
Sixty nine (75.6%) and 21 (22.6%) patients experienced one or more previous urethrotomies and/or urethroplasties, respectively. Significant
improvements of voiding symptoms assessed by Qmax and the International Consultation on Incontinence Questionnaire Male Lower
Urinary Tract Symptoms (ICIQ-MLUTS) module, and HRQoL assessed by EQ-5D visual analogue (EQ-VAS) demonstrated responsiveness
to change (all p-values <0.001; Table 1). While ICIQ-UI scores did not change (p>0.05), IIEF-5 scores improved significantly (p=0.048).
Internal consistency was high with Cronbach's α of 0.83 for the overall ICIQ-MLUTS. Forty (43%) patients also completed the USS-PROM 6
months after surgery, which was sufficient to assess reliability: test-retest intraclass correlation coefficient was 0.94 for ICIQ-MLUTS,
demonstrating high reproducibility. There was a negative correlation between change in ICIQ-MLUTS total score and change in Qmax (r=-
0.40) demonstrating moderate criterion validity.

CONCLUSIONS: Here, we present the largest prospective study validating the USS-PROM. To our best knowledge, we validated the USS-
PROM into German for the first time. Furthermore, we demonstrated, that erectile function is important to assess in patients undergoing
BMGU for urethral stricture disease, underscoring the need for its inclusion in future USS-PROMs. Longer FU assessed by USS-PROM is
needed to evaluate its mid- and long-term value.

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