Analysing the Impact of Balloon Inflated vs Balloon Deflated Push Manoeuvres in Chronically Constipated Patients During Biofeedback Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Physiological improvement
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •dyssynergia, constipation, obstructive defecation
Exclusion Criteria
- •Patients with anorectal inflammation due to conditions such as solitary rectal ulcer syndrome
- •Patients with significantly altered anorectal anatomy due to abnormalities such as large rectocele, rectal prolapse or intussusception
- •History of major anorectal surgery
- •Unable to be investigated with HR-ARM due to contraindications such as recent anorectal surgery (<6 weeks), active anorectal infections, severe anal pain or fissures(?), thrombosed haemorrhoids, or inability to tolerate anorectal catheters
- •Patients with pre-existing co-morbid inflammatory gastrointestinal conditions, including
- •Coeliac and Crohn's disease
Arms & Interventions
Balloon inflated to defecatory desire volume on push manoeuvre during biofeedback therapy
Intervention: Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy. (Other)
Balloon deflated on push manoeuvre during biofeedback therapy
Intervention: No intervention (Other)
Outcomes
Primary Outcomes
Physiological improvement
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: * with the balloon deflated (standard practice), and * with the balloon inflated to the level that gives the natural sensation of needing to open the bowels. An improvement in the pressure gradient (i.e. a higher rectal pressure relative to anal pressure) will indicate better defecatory performance.
Secondary Outcomes
- Patient experience(During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.)