Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry

Pelvic Floor Dysfunction Clinical Trial

Official title:

Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782377
• Other study ID #: 2016GA002
• Status: Completed
• Start date: February 2016
• Est. completion date: April 2017

Study information

• Verified date: November 2020
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adults over 18 years old

2. Have capacity to consent to the study

3. Patients with pelvic floor dysfunction.

Exclusion Criteria:

1. Minors under the age of 18 years old

2. Patients who lack capacity to consent

3. Patients with known rectal tumours and proctitis

4. Asymptomatic patients

Related Conditions & MeSH terms

• Pelvic Floor Dysfunction

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 (7)

Cheeney G, Nguyen M, Valestin J, Rao SS. Topographic and manometric characterization of the recto-anal inhibitory reflex. Neurogastroenterol Motil. 2012 Mar;24(3):e147-54. doi: 10.1111/j.1365-2982.2011.01857.x. Epub 2012 Jan 11. — View Citation

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	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).	during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Primary	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).	during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Primary	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).	during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Primary	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).	during single study visit- measurement taken prior to balloon inflation and post balloon inflation
Primary	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	during single study visit- measurement taken prior to balloon inflation and post balloon inflation