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

Faecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782364
• Other study ID #: 2015GA004
• Status: Completed
• Start date: November 2015
• Est. completion date: October 2016

Study information

• Verified date: January 2021
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence

Locations

Country	Name	City	State
United Kingdom	University Hospital of South Manchester	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opening Pressure	Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open	10 minutes
Primary	Opening Elastance	Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch	10 minutes
Primary	Closing Pressure	Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening	10 minutes
Primary	Closing Elastance	Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch	10 minutes
Primary	Hysteresis	Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal	10 minutes
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	10 minutes
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	10 minutes
Secondary	Manometry - Resting Pressure	anal manometry measured in cmH20	10 minutes