Balloon Inflation in Biofeedback

NCT07705542 | Recruiting

• 1 other identifier: 367053
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Chronic Constipation; Dyssynergia; Anismus

Keywords

biofeedback

Outcome Measures

Primary Outcomes (1)

• Physiological improvement

  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.

  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.

Secondary Outcomes (1)

• Patient experience

  During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.

Study Arms (2)

Balloon deflated on push manoeuvre during biofeedback therapy

ACTIVE COMPARATOR

Other: No intervention

Balloon inflated to defecatory desire volume on push manoeuvre during biofeedback therapy

ACTIVE COMPARATOR

Other: Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy.

Interventions

Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy. OTHER

This study specifically uses the patient's own defecatory desire volume during biofeedback therapy to help improve physiological push technique.

Balloon inflated to defecatory desire volume on push manoeuvre during biofeedback therapy

No intervention OTHER

The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.

Balloon deflated on push manoeuvre during biofeedback therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• dyssynergia, constipation, obstructive defecation

You may not qualify if:

• 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

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University Teaching Hospitals

Hull, HU16 5JQ, United Kingdom

RECRUITING

Related Publications (14)

• Picking, Christopher MD1; Buddam, Avanija MBBS2; Chandra, Subhash MBBS2. S1723 Rectal Perforation; A Rare Complication From Anorectal Manometry: A Case Report and Literature Review. The American Journal of Gastroenterology 116():p S765-S766, October 2021. | DOI: 10.14309/01.ajg.0000780424.47437.24

  BACKGROUND

• Park JS, Kang SB, Kim DW, Kim NY, Lee KH, Kim YH. Iatrogenic colorectal perforation induced by anorectal manometry: report of two cases after restorative proctectomy for distal rectal cancer. World J Gastroenterol. 2007 Dec 7;13(45):6112-4. doi: 10.3748/wjg.v13.45.6112.

  PMID: 18023112 BACKGROUND

• Skardoon GR, Khera AJ, Emmanuel AV, Burgell RE. Review article: dyssynergic defaecation and biofeedback therapy in the pathophysiology and management of functional constipation. Aliment Pharmacol Ther. 2017 Aug;46(4):410-423. doi: 10.1111/apt.14174. Epub 2017 Jun 29.

  PMID: 28660663 BACKGROUND

• Ozkutuk N, Eser I, Bor S. Effectiveness of Biofeedback Therapy on Quality of Life in Patients with Dyssynergic Defecation Disorder. Turk J Gastroenterol. 2021 Jan;32(1):22-29. doi: 10.5152/tjg.2020.19678.

  PMID: 33893763 BACKGROUND

• Rao SS, Benninga MA, Bharucha AE, Chiarioni G, Di Lorenzo C, Whitehead WE. ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterol Motil. 2015 May;27(5):594-609. doi: 10.1111/nmo.12520. Epub 2015 Apr 1.

  PMID: 25828100 BACKGROUND

• Black CJ, Ford AC. Chronic idiopathic constipation in adults: epidemiology, pathophysiology, diagnosis and clinical management. Med J Aust. 2018 Jul 16;209(2):86-91. doi: 10.5694/mja18.00241.

  PMID: 29996755 BACKGROUND

• Bae SH. Dyssynergic Defecation in Chronically Constipated Children in Korea. Pediatr Gastroenterol Hepatol Nutr. 2023 Mar;26(2):127-133. doi: 10.5223/pghn.2023.26.2.127. Epub 2023 Mar 7.

  PMID: 36950062 BACKGROUND

• Shi H, Li L, Huang L, Xia W, Zhu M, Zhao Y. High-Resolution Anorectal Manometry and Balloon Expulsion Test Outcomes in Functional Constipation: A Comparative Study. Med Sci Monit. 2024 Nov 7;30:e944599. doi: 10.12659/MSM.944599.

  PMID: 39506302 BACKGROUND

• Hite M, Curran T. Biofeedback for Pelvic Floor Disorders. Clin Colon Rectal Surg. 2021 Jan;34(1):56-61. doi: 10.1055/s-0040-1714287. Epub 2020 Sep 4.

  PMID: 33536850 BACKGROUND

• Rao SS, Bharucha AE, Chiarioni G, Felt-Bersma R, Knowles C, Malcolm A, Wald A. Functional Anorectal Disorders. Gastroenterology. 2016 Mar 25:S0016-5085(16)00175-X 10.1053/j.gastro.2016.02.009. doi: 10.1053/j.gastro.2016.02.009. Online ahead of print.

  PMID: 27144630 BACKGROUND

• Sadeghi A, Akbarpour E, Majidirad F, Bor S, Forootan M, Hadian MR, Adibi P. Dyssynergic Defecation: A Comprehensive Review on Diagnosis and Management. Turk J Gastroenterol. 2023 Mar;34(3):182-195. doi: 10.5152/tjg.2023.22148.

  PMID: 36919830 BACKGROUND

• Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060.

  PMID: 27270989 BACKGROUND

• Aziz I, Whitehead WE, Palsson OS, Tornblom H, Simren M. An approach to the diagnosis and management of Rome IV functional disorders of chronic constipation. Expert Rev Gastroenterol Hepatol. 2020 Jan;14(1):39-46. doi: 10.1080/17474124.2020.1708718. Epub 2020 Jan 2.

  PMID: 31893959 BACKGROUND

• Marinica Grando L, Halfvarson J, van Nieuwenhoven M. Rectal Sensory and Compliance Testing: A Method Comparison Study between High-Resolution Anorectal Manometry and Barostat Investigations. Diagnostics (Basel). 2024 Feb 6;14(4):351. doi: 10.3390/diagnostics14040351.

  PMID: 38396390 BACKGROUND

MeSH Terms

Conditions

Constipation; Ataxia

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Central Study Contacts

John Gallagher, Clinical Scientist

CONTACT

01482624036; john.gallagher6@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 15, 2026
• Study Start: May 13, 2026
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)