Anismus, Chronic Constipation, Constipation, Dyssynergia
Conditions
Keywords
biofeedback
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.
Interventions
OTHERInflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy.
This study specifically uses the patient's own defecatory desire volume during biofeedback therapy to help improve physiological push technique.
OTHERNo intervention
The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.
Sponsors
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physiological improvement | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient experience | 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. 1. Patient-perceived ease and naturalness of the push manoeuvre * Participants will rate how easy or natural it felt to perform the push manoeuvre under each condition - with the balloon inflated and deflated. * Responses will be collected immediately after the procedure using a short, structured questionnaire (e.g. Likert-type scale). * This will help determine which condition feels more realistic and comfortable to participants. 2. Reproducibility of defecatory pressure patterns * The consistency of push manoeuvre pressure profiles will be compared between the inflated and deflated balloon conditions. * This will assess whether balloon inflation improves the reliability of muscle coordination during repeated attempts. |
Countries
United Kingdom
Contacts
CONTACTJohn Gallagher, Clinical Scientist
Outcome results
None listed