Balloon Inflation in Biofeedback
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHull University Teaching Hospitals NHS Trust
About this trial
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.
Eligibility criteria
Qualifiers
dyssynergia, constipation, obstructive defecation
Disqualifiers
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
Trial design
Treatments tested in this trial
- Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy.
- No intervention
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov