High-Resolution Anorectal Manometry and Balloon Expulsion Test Outcomes in Functional Constipation: A Comparative Study.
Huihui Shi, Li Li, Ling Huang...
https://pubmed.ncbi.nlm.nih.gov/39506302/Actively Recruiting
Led by Hull University Teaching Hospitals NHS Trust · Updated on 2026-07-15
10
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether inflating the anorectal catheter balloon to a patients natural urge to defecate during biofeedback therapy improves physiological coordination and patient understanding in people with chronic constipation caused by dyssynergic defecation. This study compares this balloon-inflated method to the standard practice where the balloon remains deflated. The trial is an interventional crossover design aiming to assess treatment effectiveness and patient experience. Participants will undergo biofeedback therapy sessions using two approaches one with the balloon deflated during push maneuvers and the other with the balloon inflated to the patients defecatory desire volume. These two methods are performed sequentially during the same high-resolution anorectal manometry examination within a single study visit. The study aims to determine if the inflated balloon method enhances coordination and patient comprehension compared to the usual deflated balloon technique. During the single study visit, baseline measurements are taken with the balloon deflated, followed by intervention measurements with the balloon inflated. Researchers will evaluate physiological improvements and collect patient experience feedback immediately after completing both balloon conditions. The main outcome measures focus on physiological coordination during push maneuvers and patient understanding of the defecation process. The total participant involvement is limited to this one visit with no long-term follow-up.
CONDITIONS
Balloon Inflation in Biofeedback
J
John Gallagher, Clinical Scientist
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Hull University Teaching Hospitals NHS Trust
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a single study visit where they experience biofeedback therapy with the balloon both deflated and inflated to their defecatory desire volume during push maneuvers. Measurements and patient feedback are collected during this session.
1 visit (in-person)
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Huihui Shi, Li Li, Ling Huang...
https://pubmed.ncbi.nlm.nih.gov/39506302/S S C Rao, M A Benninga, A E Bharucha...
https://pubmed.ncbi.nlm.nih.gov/25828100/Imran Aziz, William E Whitehead, Olafur S Palsson...
https://pubmed.ncbi.nlm.nih.gov/31893959/G R Skardoon, A J Khera, A V Emmanuel...
https://pubmed.ncbi.nlm.nih.gov/28660663/Nilay Özkütük, İsmet Eşer, Serhat Bor
https://pubmed.ncbi.nlm.nih.gov/33893763/Anahita Sadeghi, Elham Akbarpour, Fatemeh Majidirad...
https://pubmed.ncbi.nlm.nih.gov/36919830/Sun Hwan Bae
https://pubmed.ncbi.nlm.nih.gov/36950062/Melissa Hite, Thomas Curran
https://pubmed.ncbi.nlm.nih.gov/33536850/Lucian Marinica Grando, Jonas Halfvarson, Michiel van Nieuwenhoven
https://pubmed.ncbi.nlm.nih.gov/38396390/Jun-Seok Park, Sung-Bum Kang, Duck-Woo Kim...
https://pubmed.ncbi.nlm.nih.gov/18023112/Hull University Teaching Hospitals NHS Trust
Lead Sponsor