Tjandra 2008.

Methods	Randomised controlled trial, parallel groups Blinding: no Follow‐up: 12 months Withdrawals: 7 Setting: single centre, Australia Intention‐to‐treat analysis: no
Participants	Enrolled: 120 Age: 63.9 (±13.2) in SNS group. 63 (±12.1) in the control group. Gender: male (9); female (111). Duration of symptoms: not mentioned Received permanent implant: 53 Lost to follow‐up: none Inclusion criteria: involuntary passage of solid or liquid stool at least once per week; refractory to medical therapy and pelvic floor exercises; and aged 35 to 86 years. Exclusion criteria: rectal prolapse, inflammatory bowel disease, congenital anorectal malformation, neurologic disorders such as Parkinson’s disease, multiple sclerosis, spinal cord injury, stoma in situ, pregnancy, external anal sphincter defect of more than 120° of the circumference, bleeding diathesis, and mental or physical disability precluding adherence to study protocol.
Interventions	A (53): SNS (Peripheral nerve evaluation for at least 7 days; then permanent implantation in participants with ≥ 50% reduction in faecal incontinence episodes per week or ≥ 50% reduction in number of days with faecal incontinence per week based on the two‐week bowel diary) B (60): control group (optimal medical therapy). Optimal medical therapy includes bulking agents, pelvic floor exercises with a team of dedicated physiotherapists, and dietary management on fluid and fibre with a team of dieticians.
Outcomes	Anorectal physiology, severity of incontinence, two‐week bowel diary (number of incontinent episodes per week, days with incontinence per week, days with staining per week and days with pads per week), faecal incontinence quality of life. Continuous data: all mean (SD) N Episodes of faecal incontinence per week at 3 months: A 2.9 (6.3) 53, B 8.1 (14.1) 60 Episodes of faecal incontinence per week at 12 months: A 3.1 (10.1) 53, B 9.4 (11.8) 60 Days with pads per week at 3 months: A 1.6 (2.6) 53, B 3 (3.8) 60 Days with pads per week at 12 months: A 2.2 (3) 53, B 3.2 (3.1) 60 Days with incontinence per week at 3 months: A 1 (1.7) 53, B 2.9 (2.4) 60 Days with incontinence per week at 12 months: A 1 (1.7) 53, B 3.1 (3.1) 60 Days with staining per week at 3 months: A 1.3 (1.7) 53, B 4.5 (2.1) 60 Days with staining per week at 12 months: A 1.4 (2) 53, B 4.5 (2.3) 60 Cleveland Clinic Incontinence Score [higher = worse] at 3 months: A 1.1 (1) 53, B 12.1 (2.1) 60 Cleveland Clinic Incontinence Score at 12 months: A 1.2 (1.8)53, B 14.1 (1.9) 60 Quality of Life SF12 [higher = better]: SF12 Physical at 3 months: A 43.18 (11.68) 53, B 41.5 (9.89) 60 SF12 Physical at 12 months: A 42.22 (9.25) 53, B 40.5 (10.2) 60 SF12 Mental at 3 months: A 50.16 (10.41) 53, B 47.82 (10.66) 60 SF12 Mental at 12 months: A 49.22 (10.88) 53, B 48.22 (10.12) 60 Quality of Life ASCRS Faecal Incontinence Quality of Life Index (FIQL) [higher = better]: Lifestyle at 3 months: A 3.34 (0.72) 53, B 2.12 (0.91) 60 Lifestyle at 12 months: A3.31 (0.72) 53, B 2.31 (0.89) 60 Coping at 3 months: A 2.87 (0.8) 53, B 1.85 (0.92) 60 Coping at 12 months : A 2.68 (0.87) 53, B 1.86 (0.88) 60 Depression/self perception at 3 months: A 3.31 (0.77) 53, B 2.68 (0.65) 60 Depression/self perception at 12 months: A 3.25 (0.8) 53, B 2.64 (0.84) 60 Embarrassment at 3 months: A 2.89 (0.85) 53, B 1.7 (0.67) 60 Embarrassment at 12 months: A 2.76 (0.94) 53, B 1.78 (0.61) 60 Anal manometry measures only reported in SNS Group A at 3 months Ability to defer defecation and worsening of faecal incontinence only reported in SNS Group A at 3 months Adverse effects only reported for SNS group: implantation site pain (6 %) particularly in slimmer participants, seroma (2%) which required percutaneous aspiration and excessive tingling in the vaginal region (9%).
Notes	Severity of incontinence was assessed by the Wexner's incontinence score. The score ranged from 0 (normal continence) to 20 (maximum incontinence). Quality of life was assessed using Fecal Incontinence Quality of Life index (FIQL) of The American Society of Colon and Rectal Surgeons; and the standard short form‐12 health survey quality of life questionnaire (SF‐12).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation was performed from the central registry by using sealed envelopes
Allocation concealment (selection bias)	Low risk	Randomisation was performed from the central registry by using sealed envelopes
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants could not be not blinded and the control group did not have sham stimulation
Blinding of outcome assessment (detection bias) All outcomes	High risk	Unblinded assessment for both control and experimental group
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	7 participants in the SNS group stopped early but have been counted in the denominators
Selective reporting (reporting bias)	Low risk	Data from all participants reported
Other bias	Low risk	None identified