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Is the ICIQ-SF questionnaire reliable in a real-life setting? Results of a prospective single-center study

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Sources of Funding: none

Introduction

The aim of the study is to assess functional outcomes, using validated questionnaires, in a large group of patients after robot-assisted radical prostatectomy (RARP) in a single center. We also assessed the correlation between ICIQ-SF and EORTC QLQ-C30 results in order to evaluate the association between objective measurements and &[Prime]return to normal activities&[Prime] which represents the &[Prime]real life&[Prime] functional goal of this technique.

Methods

363 patients underwent RARP between September 2009 and August 31st 2016. All data were prospectively collected in a compulsory regional database (Flemish cancer registry). The database was accessed on August 2016. Pre- and post-operative ICIQ-SF and EORTC QLQ-C30 questionnaires were available for every patient. Minimal clinical important difference (MCID) values between pre and post-operative scores (defined as the smallest difference in score in the domain of interest which patients perceive as successful) were used to define a successful outcome after surgery. Paired T-test analyses were used to compare pre and post-operative results. Patients where then subdivided, according to the MSID, in two groups: patients with successful outcome and without successful outcome. Chi-squared test was used to investigate the relationship between ICIQ-SF and EORTC QLQ-C30 results.

Results

Mean follow up was 13.5 months (median 11, range 1-43). Before surgery, 81% of patients reported a ICIQ-SF score of 0. Using MCID= 4,11 points, this proportion decreased to 60% (N=227), p=0.26. At baseline 45% of patients had Global health scores of 100 (45%). After surgery this proportion was 52%. MCID was 6,67, (p=0.00). Before surgery 76% and 88% of patients resulted to have 100 points in Physical and Role functioning respectively. After surgery this proportion decreased to 71.6% and 67% (p=0.89, 0.043) respectively. MCID resulted to be 6.4 and 9.1 points respectively. The results obtained for each EORTC QLQ-C30 domain were compared to the objective results of the ICIQ-SF. Satisfactory EORTC outcomes were not associated to satisfactory ICIQ-SF scores (all p≤ 0.05).

Conclusions

According to our knowledge, this is the first prospective, single center study comparing ICIQ-SF results and the real-life outcomes addressed with EORTC QLQ-C30, of a big cohort of patients submitted to RARP. We showed that quality of life is not only determined by objective continence outcomes and should be associated with more true-life questionnaires, in order to improve the knowledge and the treatment of this group of patients._x000D_ _x000D_

Funding

none

Authors
Manuela Tutolo
Youri Bekhuis
Wouter Everaerts
Alberto Briganti
Steven Joniau
Ben Van Cleynenbreugel
Giulia Castagna
Enrico Ammirati
Emanuele Zaffuto
Dirk De Ridder
Frank Van Der Aa
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