The Impact of Fluoroscopy During Percutaneous Nerve Evaluation on Subsequent Implantation of a Sacral Neuromodulator Among Women With Pelvic Floor Disorders: A Randomized, Noninferiority Trial
| Autor: | Kate V. Meriwether, Jeremy Gaskins, Casey L Kinman, Sean L. Francis, Ankita Gupta, J Ryan Stewart, Nazir Uddin, Deslyn T.G. Hobson |
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| Rok vydání: | 2020 |
| Předmět: |
medicine.medical_specialty
Percutaneous Lumbosacral Plexus Electric Stimulation Therapy Logistic regression Pelvic Floor Disorders 03 medical and health sciences 0302 clinical medicine medicine Humans Fecal incontinence Fluoroscopy Stage (cooking) Prospective cohort study Univariate analysis medicine.diagnostic_test business.industry General Medicine medicine.disease Electrodes Implanted Surgery Treatment Outcome Anesthesiology and Pain Medicine Neurology Overactive bladder Female Neurology (clinical) medicine.symptom business 030217 neurology & neurosurgery |
| Zdroj: | Neuromodulation: Technology at the Neural Interface. 23:1164-1171 |
| ISSN: | 1094-7159 |
| Popis: | Objectives To evaluate whether percutaneous nerve evaluation (PNE) without fluoroscopy is inferior to fluoroscopy use in women undergoing trials of sacral neuromodulation (SNM) for pelvic floor disorders (PFDs). Materials and methods In an unblinded noninferiority trial, women undergoing PNE were randomized to fluoroscopy or no fluoroscopy. The primary outcome was "success" and defined as implantation of the permanent SNM device within three months of PNE. At an expected 40% success and a 30% noninferiority threshold, 33 participants in each group were needed for 80% power (α = 0.05). Univariate analyses and a logistic regression model adjusting for univariate variables associated with the primary outcome were performed. Results From April 2016 to December 2018, 74 participants underwent PNE of which 36 underwent PNE with fluoroscopy and 38 without. The fluoroscopy group had less baseline mean daily voids compared to the no fluoroscopy group (10.79 ± 6.48 vs. 16.21 ± 10.05, p = 0.01). PNE performed without fluoroscopy had similar success (18/38, 47.4%) compared to fluoroscopy (21/36, 58.3%), meeting our noninferiority definition (difference 10.9%, 90% CI -8% to 30%, p = 0.049). In a logistic regression model adjusting for age, Charlson comorbidity index, stage of prolapse, and number of baseline voids per day, trial success was still similar between the two groups (adjOR 1.82, 95% CI 0.52 to 6.94, p = 0.36). Conclusions PNE performed without fluoroscopy is noninferior to PNE with fluoroscopy use for the outcome of SNM device implantation within three months among women undergoing therapy for PFDs. |
| Databáze: | OpenAIRE |
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