A new validated score for detecting patient-reported success on postoperative ICIQ-SF: a novel two-stage analysis from two large RCT cohorts

Abstract

Introduction and hypothesisThe Patient Global Impression of Improvement (PGI-I) and International Consultation of Incontinence Questionnaire – Short Form (ICIQ-SF) are validated instruments for the assessment of patient reported outcome measures (PROM) following treatment of stress urinary incontinence (SUI). However, there is a paucity of evidence as to what represents a successful postintervention ICIQ-SF score. To determine the correlation between the postoperative ICIQ-SF scores with the PGI-I outcomes, the latter was considered one of the standard PROM following surgical treatment for SUI. The aim of this study was to determine, and if appropriate validate, an ICIQ-SF cut-off score that can predict a successful PROM as determined by PGI-I.MethodsFour large datasets yielding 674 ICIQ-SF score/PGI-I outcome data pairs were used in this study for (a) determining and (b) validating the cut-off ICIQ-SF score for a successful PGI-I outcome. Two long-term follow-up datasets were used representing follow-up periods of 3 and 8 years of a randomized controlled trial (RCT) performed between April 2005 and April 2007 in a tertiary urogynaecology centre in Scotland, UK. All patients had urodynamic SUI or mixed urinary incontinence (MUI, with predominant SUI) and were randomized to treatment with either an inside-out or an outside-in transobturator tape (TVT-O or TOT, respectively) as a sole procedure. The datasets yielded 432 ICIQ-SF score/PGI-I outcome data pairs. Successful outcome was defined as “very much improved/much improved” on the PGI-I scale. SPSS v. 22.0 (IBM Corp., Armonk, NY) was used for all statistical analyses. The correlations and cut-off scores generated were then validated on two independent datasets representing the 1-year and 4-year follow-up periods of the multicentre RCT in six units in the UK. The datasets yielded 242 ICIQ-SF score/PGI-I outcome data pairs. All patients had urodynamic SUI or MUI (with predominant SUI) and were randomized to either adjustable single incision minisling (SIMS) or TVT-O.ResultsSignificant correlations at the 0.01 level (two-tailed) were clearly demonstrated between ICIQ-SF scores at follow up and PGI-I outcomes in terms of success/failure in both the generation and validation datasets. Higher ICIQ-SF scores correlated with a ‘poorer’ PGI-I score. Using ROC analysis, a postoperative ICIQ-SF score of 6 was validated as approximately 90 % sensitive and 85 % specific for success/failure with a high Cohen’s kappa coefficient of 0.83 (95 % CI 0.74 – 0.89).ConclusionsThis two-stage study provided a robust well-validated postoperative ICIQ-SF cut-off score (of 6/21) that is likely to be associated with a patient-reported successful outcome on the PGI-I following surgical treatment with a midurethral sling in women at different stages of follow-up over 1 – 8 years. Such a cut-off score could enable the comparison of results between various studies and serve as a valuable guide for surgeons to counsel patients before and/or after surgical treatment. Our study fills a research g...

Mid‐term safety and efficacy of the ALTIS® single‐incision sling for female stress urinary incontinence: less mesh, same results

“…Regarding erosion, after nearly 2 years of follow-up, there have been no vaginal or vesical/ urethral erosions. We can compare it with the 3.5% of Kocjancic et al [7] or the 2% (8% if including exposure of the adjustment thread) of Dias et al [15]. We cannot explain this according to age because our mean age (59 years) was older than the other two studies (54 and 53 years).…”

“…We are strict about this goal, as we think that patients’ perception of success is an important objective. Karmakar et al recently tried to establish a threshold point in the ICIQ to evaluate patients’ satisfaction. According to these authors, this score would be 6/21.…”

Patients' satisfaction and safety of bulk injection therapy Urolastic for treatment of stress urinary incontinence: A cross‐sectional study

“…Finally, one could argue that validated questionnaires such as the ICIQ‐SF have no additional value when assessed only after surgery. However, a strong correlation between PGI‐I and ICIQ‐SF as well as validation of a cutoff score of the ICIQ‐SF postoperatively have been reported 22 …”

The Effect of Pelvic Floor Muscle Training On Incontinence Problems After Radical Prostatectomy

“…The ICIQ form has been described as a new scale that can be used in epidemiological research and in routine clinical evaluation of incontinence and quality of life ( Karmakar, Mostafa, & Abdel-Fattah, 2017 ). Gotoh, Homma, Funahashi, Matsukawa, and Kato (2009) evaluated the scale’s psychometric properties, and its reliability was confirmed by Çetinel (2005) in Turkey.…”