Faecal IncontinenceNCT02782364
Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter
An observational study of Faecal Incontinence, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Faecal Incontinence
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Oct 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of faecal incontinence
Who may be able to join
- adults over 18 years
- have capacity to consent to the study
- patients with symptoms of faecal incontinence
Who cannot join
- minors under age of 18 years old
- patients who lack capacity to consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of South Manchester
Manchester, Greater Manchester, M23 9LT
About this study
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.
Read more
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:
- Stepwise then fast-fill
- Fast-fill then stepwise
- Conditions
- Faecal Incontinence
- Keywords
- Faecal Incontinence
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Faecal Incontinence: fast-fill measurement first | 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. 18 patients will undergo fast-fill measurement first. | |
| Faecal Incontinence: step-wise measurement first. | 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. 18 patients will have step-wise measurement first. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opening Pressure
Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
Measured: 10 minutes
Opening Elastance
Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
Measured: 10 minutes
Closing Pressure
Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
Measured: 10 minutes
Closing Elastance
Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
Measured: 10 minutes
Hysteresis
Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
Measured: 10 minutes
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
Measured: 10 minutes
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
Measured: 10 minutes
Secondary outcomes (1)
Manometry - Resting Pressure
anal manometry measured in cmH20
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Faecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karen J Telford, MBChBMDFRCS, Study chair, University Hospital of South Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782364
- Sponsor's protocol ID
- 2015GA004
- Status last verified
- Jan 2021
- First submitted
- 12 May 2016
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: individual patient data will not add any further information to the overall data
Publications
Klarskov N, Saaby ML, Lose G. A faster urethral pressure reflectometry technique for evaluating the squeezing function. Scand J Urol. 2013 Dec;47(6):529-33. doi: 10.3109/21681805.2013.776629. Epub 2013 Mar 19.
PubMed 23506115Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES. Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943.
PubMed 23132420Klarskov N. Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.
PubMed 22381095Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique. Dis Colon Rectum. 2012 Feb;55(2):211-7. doi: 10.1097/DCR.0b013e31823b2499.
PubMed 22228166Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.
PubMed 21825892Saaby ML, Klarskov N, Lose G. Urethral pressure reflectometry before and after tension-free vaginal tape. Neurourol Urodyn. 2012 Nov;31(8):1231-5. doi: 10.1002/nau.22239. Epub 2012 Mar 27.
PubMed 22457059
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter
- ClinicalTrials.gov ID
- NCT02782364
- Acronym / sponsor ID
- 2015GA004
- Conditions
- Faecal Incontinence
- Keywords
- Faecal Incontinence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 25 May 2016 (estimated)
- Results
- Posted 10 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Stepwise then fast-fill
- Fast-fill then stepwise
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Faecal Incontinence: fast-fill measurement first | – | –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. 18 patients will undergo fast-fill measurement first. |
| Faecal Incontinence: step-wise measurement first. | – | –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. 18 patients will have step-wise measurement first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of faecal incontinence
Key inclusion criteria (3 listed)
- adults over 18 years
- have capacity to consent to the study
- patients with symptoms of faecal incontinence
Key exclusion criteria (2 listed)
- minors under age of 18 years old
- patients who lack capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opening Pressure
Time frame: 10 minutes
Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
Opening Elastance
Time frame: 10 minutes
Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
Closing Pressure
Time frame: 10 minutes
Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
Closing Elastance
Time frame: 10 minutes
Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
Hysteresis
Time frame: 10 minutes
Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
Squeeze Opening Pressure
Time frame: 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
Squeeze Opening Elastance
Time frame: 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
1 secondary outcome
Manometry - Resting Pressure
Time frame: 10 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23506115Klarskov N, Saaby ML, Lose G. A faster urethral pressure reflectometry technique for evaluating the squeezing function. Scand J Urol. 2013 Dec;47(6):529-33. doi: 10.3109/21681805.2013.776629. Epub 2013 Mar 19.
- Background: PubMed 23132420Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES. Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943.
- Background: PubMed 22381095Klarskov N. Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.
- Background: PubMed 22228166Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique. Dis Colon Rectum. 2012 Feb;55(2):211-7. doi: 10.1097/DCR.0b013e31823b2499.
- Background: PubMed 21825892Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.
- Background: PubMed 22457059Saaby ML, Klarskov N, Lose G. Urethral pressure reflectometry before and after tension-free vaginal tape. Neurourol Urodyn. 2012 Nov;31(8):1231-5. doi: 10.1002/nau.22239. Epub 2012 Mar 27.
- Individual participant dataSharing planned: No. individual patient data will not add any further information to the overall data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J Telford, MBChBMDFRCS study chair
University Hospital of South Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Faecal Incontinence, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opening Pressure (time frame: 10 minutes). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782364, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.