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

Thin 2015.

Methods Randomised parallel‐arm
 Blinding: Investigator
 Follow‐up: 6 months
 Setting: two centres, London, UK
 Intention‐to‐treat analysis: yes
Participants Enrolled: 40
 Age: 59 years (mean age)
 Gender: male (1); female (39).
 Duration of symptoms: not stated
 Inclusion criteria:
Age > 18 years
Meets NICE criteria (2007) for symptom severity and failure of previous conservative therapy
Exclusion criteria:
Inability to provide informed consent for the research study
Severe concomitant medical condition precluding randomization to operative treatment
Neurological diseases, such as diabetic neuropathy, multiple
sclerosis and progressing Parkinson’s disease
Other medical conditions precluding stimulation, such as bleeding
disorders, certain cardiac pacemakers, peripheral vascular
disease
Congenital anorectal anomalies or absence of native rectum as a
result of surgery
Present evidence of external full‐thickness rectal prolapse.
Previous rectal surgery (rectopexy/resection) < 12 months ago
Stoma in situ
Chronic bowel disease, such as inflammatory bowel disease,
chronic uncontrolled diarrhoea
Anatomical limitations that would prevent successful placement of
electrodes
Pregnancy or intention to become pregnant.
Previous experience of SNS or PTNS
Interventions SNS vs percutaenous tibial nerve stimulation (PTNS)
Outcomes FI episodes/week (total, urge and passive); symptom severity scoring with Cleveland Clinic Incontinence Score (CCIS); quality of life measurements using EQ‐5D, FIQL and SF‐36.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization sequence generated remotely by a statistician uninvolved in recruitment, and requests were made and actioned by e‐mail.
Allocation concealment (selection bias) Low risk Randomization sequence generated remotely by a statistician uninvolved in recruitment, and requests were made and actioned by e‐mail.
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Investigator blinded but unclear whether patients were blinded.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Investigator blinded but unclear whether patients were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Out of 23 participants randomised to the SNS group, 4 withdrew prior to intervention (intercurrent disease n = 1; symptoms resolved n = 1; declined further participation n = 2). Then a further 3 participants failed temporary SNS. Another participant who passed the temporary SNS withdrew from treatment owing to urgent investigation for new pararectal cyst. Moreover, in the PTNS group 1 participant withdrew before intervention (symptoms resolved).
Selective reporting (reporting bias) Low risk Pre‐specified outcomes in study protocol reported.
Other bias Low risk None identified