Hull University Teaching Hospitals
Hull, HU16 5JQ, United Kingdom
Location status: Recruiting
NCT Number: NCT07705542
Chronic constipation, particularly due to dyssynergic defecation, is common and impacts quality of life. Biofeedback therapy (BFT) is the most effective conservative treatment, teaching patients to coordinate abdominal and anal muscles during defecation. In standard practice, the rectal balloon used in high-resolution anorectal manometry (HRAM) and biofeedback is left deflated, though some centres inflate it to simulate a more natural urge to defecate.
However, the efficacy of this modification has not been validated. This study aims to determine whether performing BFT with the balloon inflated to a patient's defecatory desire volume enhances physiological coordination and patient understanding compared to the standard deflated approach.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hull, HU16 5JQ, United Kingdom
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This study specifically uses the patient's own defecatory desire volume during biofeedback therapy to help improve physiological push technique.
The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.
Time frame: During a single study visit; baseline measurements (balloon deflated) and intervention measurements (balloon inflated to the participant's desire-to-defecate volume) are obtained sequentially during the same HRAM examination.
The primary outcome measure for this study is the change in anorectal pressure gradient (the difference between rectal and anal canal pressures) recorded during the push manoeuvre on high-resolution anorectal manometry (HRAM). This measurement reflects how effectively the rectal and anal muscles work together to open the bowels - known as defecatory coordination.
The study will compare each participant's average pressure gradient when performing push manoeuvres:
An improvement in the pressure gradient (i.e. a higher rectal pressure relative to anal pressure) will indicate better defecatory performance.
Time frame: During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.
The secondary outcome measures for this study focus on participants' experiences and perceptions during the biofeedback session, as well as the consistency of their physiological responses.
Contact information is provided by the study sponsor or research team.
Hull University Teaching Hospitals NHS Trust
Other Gov
Analysing the Impact of Balloon Inflated vs Balloon Deflated Push Manoeuvres in Chronically Constipated Patients During Biofeedback Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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