Evidence Basics
InSite Design/Methods
InSite Results
Fecal Incontinence
Competition
100
Study conclusions are based on this objective
What is primary objective
100
The intent to treat analysis is based on this, rather than actual treatment received
What is randomization
100
This number is the difference (delta) between SNM and SMT success rates at 6 months based on Intent to Treat analysis
What is 19
100
In the Wexner 2010 study, this percentage of patients achieved complete continence at 12 months based on a completers analysis
What is 40.6%
100
In the ORBIT study comparing PTNS to tolterodine, this was the primary efficacy outcome
What is reduction in number of voids/24 hours at 12months
200
Evidence level classification for a randomized, controlled open-label study
What is class 1 evidence
200
Of the 70 patients randomized to SNM, this many underwent test stimulation.
What is 59
200
This is the number of patients randomized to receive SNM
What is 70
200
In the Tjandra 2008 study, this percentage of SNM patients achieved ≥50% improvement in weekly incontinent episodes at 12 months
What is 71%
200
In the most recent AUA guidelines on OAB published in May 2014, Botox was labeled as this to reflect Grade B evidence
What is standard
300
Statistical value that describes the probability that the difference between treatment values is due to chance
What is p value
300
Prior to study enrollment, this was the median number of medications patients had attempted
What is 2
300
This is the percentage of SNM patients in the subgroup UUI analysis that reported complete continence at 6 months.
What is 39%
300
For fecal incontinence, SNM demonstrates significant improvements in this many domains of the Fecal Incontinence Quality of Life (FIQOL) scale.
What is 4
300
In the ABC study comparing Botox to anticholinergic therapy, this percentage of patients report they had not received previous anticholinergic therapy at baseline
What is 41%
400
A method to limit selection bias when enrolling subjects
What is randomization
400
Of the 70 patients randomized to SNM, this many elected NOT to receive lead and test stimulation
What is 11
400
In the SNM group, this number is the difference in success rates (delta) between ITT and As-treated analysis
What is 15
400
In the Hull 2013 study, of the 120 initial SNM implants, this many patients completed a 60 month (5 year) follow up visit
What is 74
400
In the ORBIT study, of the 50 patients randomized to PTNS, this many completed 12 months of therapy
What is 25
500
A method to decrease patient bias and/or investigator bias to a particular treatment
What is blinding
500
This percentage of SMT patients report taking OAB medication at least 80% of the days during the 6-month study period
What is 70%
500
For the ICIQ-OABqol survey, this has been suggested as the smallest change score perceived to have clinical benefit (minimally important difference)
What is 10
500
In the Hull 2013 study, this is the probability of a patient having explant (for any reason) after 5 years
What is 19%
500
In the ORBIT study, this was the only efficacy assessment that demonstrated a statistically significant difference between treatment groups
What is GRA (global response assessment)
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