| Methods |
Randomised controlled trial. |
| Participants |
10 people (7 women) with passive faecal incontinence and low maximal resting anal pressure but with intact sphincters demonstrated on endoanal ultrasound scan
Median duration of incontinence: 2 years (range 1 to 7)
Groups comparable at baseline on maximal resting anal pressure (cross‐over)
Exclusion criteria: pregnant women, ischaemic heart disease, aortic aneurysm, uncontrolled hypertension, inflammatory bowel disease, other secondary causes of FI |
| Interventions |
A: 0% gel (placebo containing no active ingredient)
B: 10% phenylephrine gel in identical coded foil tubes
C: 20% phenylephrine gel
D: 30% phenylephrine gel
E: 40% phenylephrine gel
Duration of treatment: 1 anal application per day, minimum 48 hours apart
Assessment: one and two hours after application |
| Outcomes |
Maximal resting anal pressure: comparable at baseline on all study days
Maximal resting anal pressure: 7 increased, no change in 3 participants
D & E: maximal resting anal pressure increased to within normal range (P < 0.05 versus placebo group A)
B & C: maximal resting anal pressure increased but below normal range
Effect sustained for a median of 7 hours
Adverse effects: two people experienced a stinging/burning sensation immediately after application of phenylephrine gel, which settled within 20 minutes |
| Notes |
Washout of 48 hours between daily doses |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
It is reported that "Gels were applied in a random order..................." however it is not specified how sequence was generated |
| Allocation concealment (selection bias) |
Unclear risk |
It is reported that "Gels were applied in a random order..................." however it is not specified if the allocation was concealed or no |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
It is reported that both the investigator and patients were unaware of the nature of each gel. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
It is not specified if the outcome was assessed by the investigator or someone else. |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing data |
| Selective reporting (reporting bias) |
Unclear risk |
Protocol not available |
| Was use of a cross over design appropriate? |
Low risk |
This is a randomised controlled trial and not a cross‐over trial and this domain of risk of bias assessment is not applicable and would be judged as low risk. |
| Is it clear that the order of receiving treatment was randomised? |
Low risk |
This is a randomised controlled trial and not a cross‐over trial and this domain of risk of bias assessment is not applicable and would be judged as low risk. |
| Can it be assumed that the trial was not biased from carry over effects? |
Low risk |
This is a randomised controlled trial and not a cross‐over trial and this domain of risk of bias assessment is not applicable and would be judged as low risk. |
