Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter

• Sponsor: Manchester University NHS Foundation Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT02782364
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Duration (Months): 11
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Faecal Incontinence

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter
• Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Oct 1, 2016
• Actual Study Completion Date: Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Opening Pressure [10 minutes]

   Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open

2. Opening Elastance [10 minutes]

   Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch

3. Closing Pressure [10 minutes]

   Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening

4. Closing Elastance [10 minutes]

   Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch

5. Hysteresis [10 minutes]

   Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal

6. 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

7. 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

Secondary Outcome Measures

1. Manometry - Resting Pressure [10 minutes]

   anal manometry measured in cmH20

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital of South Manchester	Manchester	Greater Manchester	United Kingdom	M23 9LT

Sponsors and Collaborators

• Manchester University NHS Foundation Trust

Investigators

• Study Chair: Karen J Telford, MBChBMDFRCS, University Hospital of South Manchester

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hornung 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. Erratum in: Br J Surg. 2013 Jan;100(2):301.
• 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.
• Klarskov 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.
• Mitchell 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.
• Mitchell 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.
• Saaby 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.

• Responsible Party: Manchester University NHS Foundation Trust
• ClinicalTrials.gov Identifier: NCT02782364
• Other Study ID Numbers: 2015GA004
• First Posted: May 25, 2016
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Manchester University NHS Foundation Trust: Faecal Incontinence
• Additional relevant MeSH terms: Fecal Incontinence

Study Results

Participant Flow

Recruitment Details	Patients attending clinic for routine evaluation of faecal incontinence were approached to particpate in this study

Arm/Group Title	Stepwise First, Then Fast-fill	Fast-fill First, Then Stepwise
Arm/Group Description	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. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo stepwise measurement first and another half of the patients will have stepwise measurement first. Patients in this arm underwent stepwise, followed by a two minute rest, then fast fill, followed by a two minute rest, and then by manometry	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. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo fast-fill measurement first and another half of the patients will have step-wise measurement first. Patient min this arm underwent fast fill, followed by a two minute rest, then step wise, followed by a two minute rest, and then by manometry
Period Title: Overall Study
STARTED	18	18
COMPLETED	18	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Faecal Incontinence
Arm/Group Description	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
Overall Participants	32
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	23 71.9%
>=65 years	9 28.1%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	26 81.3%
Male	6 18.8%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United Kingdom	32 100%

Outcome Measures

1. Primary Outcome

Title	Opening Pressure
Description	Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepwise	Fast-fill
Arm/Group Description	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.	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.
Measure Participants	32	32
Median (Full Range) [cmH2O]	35.13	37.5

2. Primary Outcome

Title	Opening Elastance
Description	Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepwise	Fast-fill
Arm/Group Description	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.	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.
Measure Participants	32	32
Median (Full Range) [cm H2O/mm2]	0.84	1.31

3. Primary Outcome

Title	Closing Pressure
Description	Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepwise	Fast-fill
Arm/Group Description	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.	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.
Measure Participants	32	32
Median (Full Range) [cmH2O]	27.22	22.7

4. Primary Outcome

Title	Closing Elastance
Description	Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepwise	Fast-fill
Arm/Group Description	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.	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.
Measure Participants	32	32
Median (Full Range) [cm H2O/mm2]	0.88	1.11

5. Primary Outcome

Title	Hysteresis
Description	Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepwise	Fast-fill
Arm/Group Description	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.	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.
Measure Participants	32	32
Median (Full Range) [percentage]	19.04	35.75

6. Primary Outcome

Title	Squeeze Opening Pressure
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepwise	Fast-fill
Arm/Group Description	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.	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.
Measure Participants	32	32
Median (Full Range) [cmH2O]	59.47	69.87

7. Primary Outcome

Title	Squeeze Opening Elastance
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stepwise	Fast-fill
Arm/Group Description	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.	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.
Measure Participants	32	32
Median (Full Range) [cmH20/mm2]	1.06	1.27

8. Secondary Outcome

Title	Manometry - Resting Pressure
Description	anal manometry measured in cmH20
Time Frame	10 minutes

Outcome Measure Data

Analysis Population Description

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/Group Title	Faecal Incontinence
Arm/Group Description	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 and another 18 patients will have step-wise measurement first. This study is classed as observational as the randomisation is solely the order in which the two tests are performed. The test itself can be performed at can be performed at different rates and this study is to evaluate the two
Measure Participants	29
Median (Full Range) [cmH20]	45

Adverse Events

Time Frame	Patients were recruited over a 12 month window. This study treatment and data was collected on one day (a point in time measurement) and any adverse events (if present) would occur at the time of measurement. If no events were noted at this point, then further data was not collected
Adverse Event Reporting Description	AEs or SAEs would occur during or directly after the procedure and noted by the attending clinician.
Arm/Group Title	Stepwise First, Then Fast-fill		Fast-fill First, Then Stepwise
Arm/Group Description	Stepwise First, Then Fast-fill measurement. Observational study where patients with faecal incontinence undergo two AAR measurements; first with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo stepwise measurement first and another half of the patients will have stepwise measurement first. Patients in this arm underwent stepwise, followed by a two minute rest, then fast fill, followed by a two minute rest, and then by manometry Previous Work has been carried out looking at the sequence has shown no difference in the order. Therefore to keep consistency this method has been continued and results combined		Fast-fill measurement then Stepwise measurement. Observational study where patients with faecal incontinence undergo two AAR measurements; with the newer fast-fill technique and the second with the original step-wise technique. A further standard manometry measurement will be taken. To reduce the bias of one test on the other, the order of the test were randomised so that half of the patients will undergo fast-fill measurement first and another half of the patients will have step-wise measurement first. Patient min this arm underwent fast fill, followed by a two minute rest, then step wise, followed by a two minute rest, and then by manometry. Previous Work has been carried out looking at the sequence has shown no difference in the order. Therefore to keep consistency this method has been continued and results combined
All Cause Mortality
	Stepwise First, Then Fast-fill		Fast-fill First, Then Stepwise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Serious Adverse Events
	Stepwise First, Then Fast-fill		Fast-fill First, Then Stepwise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Stepwise First, Then Fast-fill		Fast-fill First, Then Stepwise
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.