An observational study in Pelvic Floor Dysfunction, sponsored by Manchester University NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-02.
Sponsored by Manchester University NHS Foundation Trust · Observational
Anal Acoustic Reflectometry (AAR) is a reliable and reproducible 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. In previous studies AAR has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence.
The Recto-anal Inhibitory Reflex (RAIR) is a normal response when the rectum fills with faeces, fluid or air, whereby there is a change in the pressures within the anal canal to determine the type of contents. This can be absent or altered in patients who have difficulty in opening their bowels. The RAIR is currently measured by anal manometry using a 4.9mm catheter, resulting in an anal canal which is already partially opened prior to the measurement, and potentially distorted.
AAR is considered a catheter free technique as the balloon has a cross-sectional area of only 0.4mm2 when collapsed. The investigators propose to measure the RAIR using a 1.7mm diameter catheter alongside the AAR balloon to determine the effect that its placement has on the recorded parameters of AAR. This aims to improve our understanding of the opening and closing of the anal canal in response to distension of the rectum.
Manchester University NHS Foundation Trust is the lead sponsor of 135 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of pelvic floor dysfunction
Exclusion Criteria:
Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed Note, that initial inclusion of Squeeze parameters was detailed in error, these were not compared in this study and were compared in previous study
Opening Pressure
Measurements of differences in Opening pressure (Op - cm H2O) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Opening Elastance
Measurements of differences in Opening Elastance (Oe - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Closing Pressure
Measurements of differences in Closing Pressure (Cp - cm H2O) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Closing Elastance
Measurements of differences in Closing Elastance (Ce - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Hysteresis
Measurements of differences in Hysteresis (%) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR). Hysteresis is the extent of energy expenditure during opening and closing of the anal canal and represents the difference between opening and closing pressure and is expressed as a percentage
Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
| Milestone | Pelvic Floor Dysfunction |
|---|---|
| Started | 40 |
| Completed | 35 |
| Not completed | 5 |
| Withdrew: Physician decision | 5 |
Measurements of differences in Opening pressure (Op - cm H2O) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
| cmH2O | Pre-Rair | Post-RAIR |
|---|---|---|
| Opening Pressure | 34.44 (13.84 to 82.96) | 15.41 (0 to 50.53) |
Measurements of differences in Opening Elastance (Oe - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
| cmH2O/mm2 | Pre-Rair | Post-RAIR |
|---|---|---|
| Opening Elastance | 1.39 (0.74 to 2.18) | 1.1 (0 to 2.13) |
Measurements of differences in Closing Pressure (Cp - cm H2O) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
| cmH2O | Pre-Rair | Post-RAIR |
|---|---|---|
| Closing Pressure | 20.06 (6.01 to 55.92) | 8.00 (0 to 35.41) |
Measurements of differences in Closing Elastance (Ce - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
| cmH2O/mm2 | Pre-Rair | Post-RAIR |
|---|---|---|
| Closing Elastance | 1.31 (0.64 to 2.29) | 1.13 (0 to 1.73) |
Measurements of differences in Hysteresis (%) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR). Hysteresis is the extent of energy expenditure during opening and closing of the anal canal and represents the difference between opening and closing pressure and is expressed as a percentage
| percent | Pre-Rair | Post-RAIR |
|---|---|---|
| Hysteresis | 39.71 (26.2 to 56.86) | 39.9 (0 to 82.28) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pelvic Floor Dysfunction | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | Pelvic Floor Dysfunction |
|---|---|
| Median | 57.5 (34 to 77) |
| Sex: Female, Male(Participants) | Pelvic Floor Dysfunction |
|---|---|
| Female | 26 |
| Male | 6 |
| Race and Ethnicity Not Collected(Participants) | Pelvic Floor Dysfunction |
|---|
| Region of Enrollment(participants) | Pelvic Floor Dysfunction |
|---|---|
| United Kingdom | 32 |
Plan to share: No
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Manchester University NHS Foundation Trust