Heymen 2009.
Methods | Randomised controlled trial. Analysis: intention to treat. |
|
Participants | Setting and country: single centre. Tertiary referral hospital in USA. Inclusion criteria: consecutive series of "chronically incontinent patients referred to University of North Carolina Hospitals". At least 1 teaspoon of faeces at least weekly; anatomic defects on anal ultrasound permissible. Exclusion criteria: flatus incontinence and staining only; psychotic disorder and severe cognitive impairment Number of participants: 168 randomised. After run‐in period of conservative management, 108 started intervention as randomised. Age: average 59.6 years Sex: 83 female, 25 male Other characteristics of participants: |
|
Interventions | PFMT alone 63 participants. PFMT plus manometric biofeedback 45 participants. Both groups taught behavioural strategies to avoid incontinence. |
|
Outcomes | Primary: Faecal Incontinence Severity Index (FISI) Secondary: Days per week incontinent; complete continence (no staining); squeeze pressure and abdominal tension; Faecal incontinence quality of life score (FI‐QoL); telephone report to therapist of "adequate relief" |
|
Notes | Randomised patients prior to run‐in period which resulted in unbalanced group sizes: 35 patients reported adequate relief from run‐in and 24 withdrew, resulting in 109 patients only entering treatment phase. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Co‐investigator produced the randomisation table using random number generator |
Allocation concealment (selection bias) | Unclear risk | Group membership was reported to the therapist after patient arrived for initial visit. Patients randomised prior to unblinded run‐in phase |
Blinding (performance bias and detection bias) All outcomes | High risk | Therapist telephoned participant to ask if they had experienced "adequate relief" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis reported: authors replaced missing values with zero |