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

NCT02782364 | Completed Results

• 1 other identifier: 2015GA004
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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. 1.Stepwise then fast-fill
2. 2.Fast-fill then stepwise

Conditions

Faecal Incontinence

Keywords

Faecal Incontinence

Outcome Measures

Primary Outcomes (7)

• Opening Pressure

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

  10 minutes

• Opening Elastance

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

  10 minutes

• Closing Pressure

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

  10 minutes

• Closing Elastance

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

  10 minutes

• Hysteresis

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

  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

  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

  10 minutes

Secondary Outcomes (1)

• Manometry - Resting Pressure

  10 minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of faecal incontinence

You may qualify if:

• adults over 18 years
• have capacity to consent to the study
• patients with symptoms of faecal incontinence

You may not qualify if:

• minors under age of 18 years old
• patients who lack capacity to consent

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

University Hospital of South Manchester

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

Related Publications (6)

• 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.

  PMID: 23506115 BACKGROUND

• 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.

  PMID: 23132420 BACKGROUND

• 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.

  PMID: 22381095 BACKGROUND

• 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.

  PMID: 22228166 BACKGROUND

• 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.

  PMID: 21825892 BACKGROUND

• 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.

  PMID: 22457059 BACKGROUND

MeSH Terms

Conditions

Encopresis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Results Point of Contact

• Title: Karen Telford
• Organization: University Hospital of South Manchester

karen.telford@uhsm.nhs.uk

01612916654

Study Officials

• Karen J Telford, MBChBMDFRCS

  University Hospital of South Manchester

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: May 25, 2016
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 22, 2021
• Results First Posted: December 10, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)