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. |