Background: Sacral neuromodulation (SNM) treatment of refractory urinary symptoms is associated with quality of life improvements using disease-specific instruments. There is a paucity of information relating universal health outcomes to effective treatment of urinary symptoms. The objective was to analyze changes in Patient-Reported Outcomes Measurement Information System (PROMIS) item-bank scores following SNM for treating refractory lower urinary tract symptoms (LUTS).
Materials and methods: This is a sub-analysis collected from an institutional review board approved, retrospective chart review evaluating changes between pre- and post-procedure PROMIS scores in subjects undergoing successful SNM implantation for refractory LUTS at a multidisciplinary adult continence clinic. The difference between pre- and post-procedure PROMIS scores was compared via two-sided Wilcoxon signed-rank test, with p <0.05 considered statistically significant.
Results: Of the 29 subjects, most were female (89.66%), Caucasian (68.97%), nonsmokers (89.66%) with public insurance (62.07%). The median age was 63years and body mass index was 33.2kg/m2. Procedure indications included urinary urge incontinence (83%), mixed urinary incontinence (10%), retention (17.24%), and overactive bladder (3%). Pain Interference and Depression scores had a nonsignificant improvement from 64.2 (ranging 58.9-67.5) to 60.75 (ranging 55.2-67.2), p = 0.21, and 55.2 (ranging 51.5-59.9) to 53.4 (ranging 49.5-61.1), p = 0.33, respectively. Median Physical Function scores demonstrated nonsignificant worsening following implantation from 38.0 (ranging 34.7-40.9) to 36.1 (ranging 33.1-40.8) (p = 0.25). Twenty-one subjects (72%) reported an improvement in at least 1 PROMIS item-bank with 6 subjects (21%) reporting no improvement in any of the item-banks.
Conclusions: Treatment of refractory LUTS with SNM resulted in no statistically significant changes in the PROMIS item-banks of Physical Function, Pain Interference, or Depression. Further prospective investigation is necessary to delineate the relationship of the self-reported universal-health outcomes in the treatment of LUTS.
Acknowledgments
None.
Statement of ethics
This research complies with the guidelines for human. Ethical approval and participants’ consent were not required as the data analysis was performed on a de-identified database collected under the approval of the IRB.
Conflict of interest statement
Initial findings were presented at AUGS PFD Week 2018 in Chicago, IL, USA. DJ Sanderson would like to disclose that he is a consultant with InterPRO Urology as of July 2019. PJ Doyle would like to disclose that she is the Chief Medical Officer of EndoGlow, LLC. The remaining authors have no conflicts of interest to declare.
Funding source
No external funding was received for completion of this research.
Author contributions
EMJ: Protocol/project development, data collection, statistical analysis, manuscript writing/editing;DJS: Protocol/project development, statistical analysis, manuscript writing/editing; MG: Data collection, manuscript writing/editing; PJD: Supervision, manuscript writing/editing.
Data availability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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