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. 2015 Aug 24;2015(8):CD004464. doi: 10.1002/14651858.CD004464.pub3

Kahlke 2015#.

Methods Randomised crossover trial
 Blinding: participant and investigator. Sequence generation by random number table
 Follow‐up: 3 months
 Setting: single‐centre, Germany
Withdrawals: 2 participants
Intention‐to‐treat analysis: no
Participants Enrolled: 16
 Median age (SD): 55.5 (11.8)
 Gender: female (16)
 Duration of symptoms: mean (SD): 51.9 (42.7)
 Received permanent implant: 16
 Lost to follow‐up: 0
 Inclusion criteria: not mentioned
 Exclusion criteria: not mentioned
Interventions All patients had sacral nerve modulation through a staged implantation procedure between 2009 and 2011. After 26.8 months (median) following implantation 16 out of the 31 participants agreed to be randomised into a crossover design to stimulation ON or OFF, each period lasted for 3 weeks. After 6 weeks (i.e. the two periods) participants while blinded selected the preferred period (ON or OFF) which was continued for a further 3 months. There was no treatment‐free interval.
Outcomes Frequency of bowel movements, frequency of faecal incontinence, Cleveland Clinic Incontinence Score (CCIS).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table utilised.
Allocation concealment (selection bias) Unclear risk Unclear 'Randomised crossover study'.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Participants and key study personnel blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Personnel assessing outcome were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Out of the 16 participants enrolled, 2 discontinued; the reasons cited were participant turned stimulator ON with handheld device because she had become completey incontinent (n = 1); participant fell on lower back leading to breakage of permanent lead (n = 1).
Selective reporting (reporting bias) Low risk All outcomes reported.
Other bias Low risk None identified.