| Methods |
Cross‐over randomised controlled trial |
| Participants |
12 adults (7 women) with FI after ileoanal pouch surgery for ulcerative colitis
Median age 44 years (range 29 to 67)
8 had nocturnal incontinence only, 4 had both diurnal and nocturnal incontinence
Exclusion criteria: active pouchitis, disruption of anal sphincter muscles on endoanal ultrasound examination, concomitant use of tricyclic or monoamine oxidase inhibitors, hypertension, ischaemic heart disease or aortic aneurysm. |
| Interventions |
A: 10% phenylephrine gel
B: placebo gel (0.5 mL), both used anally twice a day
Length of treatment: 4 weeks (two four‐week treatment periods with a one‐week washout period)
Dose titration: the choice of 10% phenylephrine gel was based on previous pilot studies on healthy volunteers |
| Outcomes |
Cure: A: 4/12, B: 0/12
Subjective improvement in symptoms: A: 6/12, B: 1/12
Incontinence score (28 day symptom score, n, mean, SD): A: 12, 12.2 (5.7), B: 12, 16.5 (4.4)
Adverse effects: A: 0/12, B: 0/12
Maximum anal resting pressure (n, mean, SD): A: 12, 89 (17), B: 12, 75 (14)
Anodermal blood flow (no difference) |
| Notes |
8 patients continued with loperamide during the study
Suggestion of an interaction between treatment and placebo periods, possibly reflecting an insufficient washout period |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Random assignment was performed using random numbers generated by a scientific calculator, and the randomization code was kept in the hospital pharmacy and made known to the investigators only after analysis of the completed study" |
| Allocation concealment (selection bias) |
Low risk |
"Random assignment was performed using random numbers generated by a scientific calculator, and the randomization code was kept in the hospital pharmacy and made known to the investigators only after analysis of the completed study" |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Repored as "double‐blind" trial but it is not specified who was blinded. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Repored as "double‐blind" trial but it is not specified who was blinded. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No incomplete data |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Was use of a cross over design appropriate? |
Low risk |
Yes |
| Is it clear that the order of receiving treatment was randomised? |
Low risk |
"Random assignment was performed using random numbers generated by a scientific calculator, and the randomization code was kept in the hospital pharmacy and made known to the investigators only after analysis of the completed study" |
| Can it be assumed that the trial was not biased from carry over effects? |
Unclear risk |
"...........two four‐week treatment phases separated by a one‐week washout phase." |
