Trial Outcomes & Findings for Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry (NCT NCT02782377)

NCT ID: NCT02782377

Last Updated: 2020-12-02

Results Overview

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).

• Recruitment status: COMPLETED
• Target enrollment: 40 participants
• Primary outcome timeframe: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
• Results posted on: 2020-12-02

Participant Flow

Participant milestones

Measure	Pelvic Floor Dysfunction Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed
Overall Study STARTED	40
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Pelvic Floor Dysfunction Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed
Overall Study Physician Decision	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pelvic Floor Dysfunction n=32 Participants Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed
Age, Continuous	57.5 years n=32 Participants
Sex: Female, Male Female	26 Participants n=32 Participants
Sex: Female, Male Male	6 Participants n=32 Participants
Region of Enrollment United Kingdom	32 participants n=32 Participants

PRIMARY outcome

Timeframe: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

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).

Outcome measures

Measure	Pre-Rair n=32 Participants AAR performed Prior to Rectal distension	Post-RAIR n=32 Participants AAR performed after rectal distension
Opening Pressure	34.44 cmH2O Interval 13.84 to 82.96	15.41 cmH2O Interval 0.0 to 50.53

PRIMARY outcome

Timeframe: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

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).

Outcome measures

Measure	Pre-Rair n=32 Participants AAR performed Prior to Rectal distension	Post-RAIR n=32 Participants AAR performed after rectal distension
Opening Elastance	1.39 cmH2O/mm2 Interval 0.74 to 2.18	1.1 cmH2O/mm2 Interval 0.0 to 2.13

PRIMARY outcome

Timeframe: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

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).

Outcome measures

Measure	Pre-Rair n=32 Participants AAR performed Prior to Rectal distension	Post-RAIR n=32 Participants AAR performed after rectal distension
Closing Pressure	20.06 cmH2O Interval 6.01 to 55.92	8.00 cmH2O Interval 0.0 to 35.41

PRIMARY outcome

Timeframe: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

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).

Outcome measures

Measure	Pre-Rair n=32 Participants AAR performed Prior to Rectal distension	Post-RAIR n=32 Participants AAR performed after rectal distension
Closing Elastance	1.31 cmH2O/mm2 Interval 0.64 to 2.29	1.13 cmH2O/mm2 Interval 0.0 to 1.73

PRIMARY outcome

Timeframe: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

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

Outcome measures

Measure	Pre-Rair n=32 Participants AAR performed Prior to Rectal distension	Post-RAIR n=32 Participants AAR performed after rectal distension
Hysteresis	39.71 percent Interval 26.2 to 56.86	39.9 percent Interval 0.0 to 82.28

Adverse Events

Pelvic Floor Dysfunction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nick Heywood

University Hospital of South Manchester

Phone: +447739002473

Email: nheywood@doctors.org.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place