Faecal Incontinence
Conditions
Keywords
Faecal Incontinence
Brief summary
Anal Acoustic Reflectometry (AAR) is a technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles. The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. Despite the two measurements being within the normal range, some patients can have significant faecal incontinence. This has prompted clinicians to search for a better investigation to guide the management of this condition. AAR is a reproducible and repeatable technique that has been used as a research technique in the assessment of faecal incontinence. It has been shown to correlate with symptom severity and, unlike manometry, is able to distinguish between different symptomatic subgroups with faceal incontinence. In our studies so far the investigators have increased the bag inflation pressure a step at a time which means that each study takes about 20 minutes to perform. The limitation of this method is that during the measurement of squeeze pressure the sphincter muscle is subject to fatigue. A recent study using the acoustic technique in the urethra has demonstrated a faster method of recording measurements over an 8 minute period. The investigators propose to study the fatiguability effects of this faster technique and validate the method against the existing step-wise technique and standard anal manometry. Patients will be randomised into two groups: 1. Stepwise then fast-fill 2. Fast-fill then stepwise
Interventions
None listed
Sponsors
Manchester University NHS Foundation Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adults over 18 years * have capacity to consent to the study * patients with symptoms of faecal incontinence
Exclusion criteria
* minors under age of 18 years old * patients who lack capacity to consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Squeeze Opening Elastance | 10 minutes | Squeeze opening elastance (Sq)e - cm H20/mm2) - the resistance of the anal canal to stretch whilst the patient is voluntarily trying to keep the anal canal closed |
| Opening Pressure | 10 minutes | Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open |
| Opening Elastance | 10 minutes | Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch |
| Closing Pressure | 10 minutes | Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening |
| Closing Elastance | 10 minutes | Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch |
| Hysteresis | 10 minutes | Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal |
| Squeeze Opening Pressure | 10 minutes | Squeeze opening pressure (SqOp - cm H20) - the pressure at which the anal canal just starts to open whilst the patient is voluntarily trying to keep the anal canal closed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manometry - Resting Pressure | 10 minutes | anal manometry measured in cmH20 |
Countries
United Kingdom
Participant flow
Recruitment details
Patients attending clinic for routine evaluation of faecal incontinence were approached to particpate in this study
Participants by arm
| Arm | Count |
|---|---|
| Faecal Incontinence Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. 16 patients will undergo fast-fill measurement first and another 16 patients will have step-wise measurement first | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | Faecal Incontinence | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 9 Participants | — |
| Age, Categorical Between 18 and 65 years | 23 Participants | — |
| Age, Continuous | 60 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 32 participants | — |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 6 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 18 |
| other Total, other adverse events | 0 / 18 | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 | 0 / 18 |
Outcome results
Primary
Closing Elastance
Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Closing Elastance | 0.88 cm H2O/mm2 |
| Fast-fill | Closing Elastance | 1.11 cm H2O/mm2 |
Primary
Closing Pressure
Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Closing Pressure | 27.22 cmH2O |
| Fast-fill | Closing Pressure | 22.7 cmH2O |
Primary
Hysteresis
Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Hysteresis | 19.04 percentage |
| Fast-fill | Hysteresis | 35.75 percentage |
Primary
Opening Elastance
Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Opening Elastance | 0.84 cm H2O/mm2 |
| Fast-fill | Opening Elastance | 1.31 cm H2O/mm2 |
Primary
Opening Pressure
Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Opening Pressure | 35.13 cmH2O |
| Fast-fill | Opening Pressure | 37.5 cmH2O |
Primary
Squeeze Opening Elastance
Squeeze opening elastance (Sq)e - cm H20/mm2) - the resistance of the anal canal to stretch whilst the patient is voluntarily trying to keep the anal canal closed
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Squeeze Opening Elastance | 1.06 cmH20/mm2 |
| Fast-fill | Squeeze Opening Elastance | 1.27 cmH20/mm2 |
Primary
Squeeze Opening Pressure
Squeeze opening pressure (SqOp - cm H20) - the pressure at which the anal canal just starts to open whilst the patient is voluntarily trying to keep the anal canal closed
Time frame: 10 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Squeeze Opening Pressure | 59.47 cmH2O |
| Fast-fill | Squeeze Opening Pressure | 69.87 cmH2O |
Secondary
Manometry - Resting Pressure
anal manometry measured in cmH20
Time frame: 10 minutes
Population: 29 patient analysed due to equipment issues performing for other 3 patients. It was pre-specified to combine data collected from the manometry regardless of the sequence of administration of techniques for AAR measurements as previous study had previously shown that the order of data collection did not impact on the measurements obtained
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Stepwise | Manometry - Resting Pressure | 45 cmH20 |