Aims
To evaluate validity and responsiveness of PFDI and PFIQ short forms across 4 multi-center studies and develop conversion formulas between short and long versions.
Methods
1006 participants in 4 prospective studies of pelvic floor disorders completed long versions of the PFDI, PFIQ and SF-36 (or SF-12) at baseline and 3 and 12 months after treatment. Responses were used to calculate scores for the short versions. We calculated correlations between scale versions using Pearson’s correlation coefficient and compared their relative responsiveness using the standardized response mean.
Results
PFDI and PFIQ short form scale scores demonstrated excellent correlations with long versions and similar responsiveness. Responsiveness was good to excellent for PFDI-20 urinary and prolapse scales, moderate for PFDI-20 colorectal scale and each of the PFIQ-7 scales, and poor for SF-36 (or SF-12) summary scores. Conversion formulas demonstrated excellent goodness of fit.
Conclusions
The long and short forms of the PFDI and PFIQ correlate well and have similar overall responsiveness in participants from 4 different prospective multicenter studies consisting of diverse patient populations with a broad range of pelvic floor disorders. The short forms provide a reliable and valid alternative in situations where reduced response burden is desired.
Background
Few studies have characterized longer-term outcomes after retropubic and transobturator midurethral slings.
Methods
Women completing 2-year participation in a randomized equivalence trial who had not received surgical retreatment for stress urinary incontinence were invited to participate in a 5-year observational cohort. The primary outcome, treatment success, was defined as no retreatment or self-reported stress incontinence symptoms. Secondary outcomes included urinary symptoms and quality of life, satisfaction, sexual function and adverse events.
Results
404 of 597 (68%) women from the original trial enrolled. Five-years after surgical treatment, success was 7.9% greater in women assigned to retropubic-sling compared to transobturator-sling (51.3% vs 43.4%, 95% CI −1.4%, 17.2%) not meeting pre-specified criteria for equivalence. Satisfaction decreased over 5-years, but remained high and similar between arms (79%, retropubic-sling vs 85%, transobturator-sling groups, p=0.15). Urinary symptoms and quality of life worsened over time (p<0.001), and women with retropubic-sling reported greater urinary urgency (P=0.001), more negative quality of life impact (p=0.02), and worse sexual function (P=0.001). There was no difference in proportion of women experiencing at least 1 adverse event (p=0.17). Seven new mesh erosions were noted (retropubic-sling-3, transobturator-sling-4).
Conclusion
Treatment success declined over 5-years for retropubic and transobturator-slings and did not meet pre-specified criteria for equivalence with retropubic demonstrating a slight benefit. However, satisfaction remained high in both arms. Women undergoing transobturator-sling reported more sustained improvement in urinary symptoms and sexual function. New mesh erosions occurred in both arms over time, although at a similarly low rate.
In this preclinical animal model, direct, but not intravenous, injection of MSCs into the injured anal sphincter at the time of repair resulted in improved contractile function of the sphincter after injury, increased matrix deposition in the external anal sphincter, and increased expression of TFG-β1 and lysyl oxidase in the acute phase after injury.
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