Introduction
It has been reported in an open-label study that the combination of alkalinized lidocaine and heparin can immediately relieve the symptoms of urinary urgency, frequency, and pain associated with interstitial cystitis (IC). This combination has also been reported to relieve pain associated with sex in patients with IC.
Aim
The aim of this study was to corroborate these findings in a multicenter setting.
Methods
The study design was a multicenter prospective, double-blind, crossover, placebo-controlled trial. Each participant met all of the clinical National Institute of Diabetes and Digestive and Kidney Diseases criteria (excluding cystoscopy) for IC. Each patient received drug and control, in random order, within 48 hours of enrolling in the study.
Main Outcome Measures
The primary outcome measure was percent change in pain score (11-point analog pain scale) 12 hours after receiving the drug or control. Secondary measures were the global assessment response (GAR) of symptoms and 12-hour average urgency reduction determined from 11-point urgency scales.
Results
Eighteen (18) patients completed the trial. The average reduction of pain over 12 hours was 21% for control and 42% for active drug (P = 0.0363). GAR was 13% for control and 50% for drug (P = 0.0137). Average urgency reduction was 13% for control and 35% for drug (P = 0.0328).
Conclusions
The combination of alkalinized lidocaine and heparin provides up to 12 hours of relief from urgency and pain associated with IC. This combination provides significant immediate relief of symptoms for patients with IC.
Tamm-Horsfall protein is qualitatively different in patients with interstitial cystitis compared to controls. These data suggest that altered Tamm-Horsfall protein may be involved in interstitial cystitis pathogenesis and it may be useful for clinical diagnosis.
These multisite data validate that abnormal glycosylation of Tamm-Horsfall protein occurs in patients with interstitial cystitis and may have a role in interstitial cystitis causation.
BackgroundWe examined the effect of advanced preparation and organisation of equipment and drugs for Pre-hospital Emergency Anaesthesia (PHEA) and tracheal intubation on procedural time, error rates, and cognitive load.MethodsThis study was a randomised, controlled experiment with a crossover design. Clinical teams (physician and paramedic) from the Emergency Medical Retrieval Service and the Scottish Air Ambulance Division were randomised to perform a standardised pre-hospital clinical simulation using either unprepared (standard practice) or pre-prepared (experimental method) PHEA equipment and drugs. Following a two-week washout period, each team performed the corresponding simulation. The primary outcome was intervention time. Secondary outcomes were safety-related incidents and errors, and degree of cognitive load.ResultsIn total 23 experiments were completed, 12 using experimental method and 11 using standard practice. Time required to perform PHEA using the experimental method was significantly shorter than with standard practice (11,45 versus 20:59) minutes: seconds; p = < 0.001). The experimental method also significantly reduced procedural errors (0 versus 9, p = 0.007) and the cognitive load experienced by the intubator assistant (41.9 versus 68.7 mm, p = 0.006).ConclusionsPre-preparation of PHEA equipment and drugs resulted in safer performance of PHEA and has the potential to reduce on-scene time by up to a third.Electronic supplementary materialThe online version of this article (10.1186/s13049-018-0549-3) contains supplementary material, which is available to authorized users.
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