ConstipationNCT07705542

Balloon Inflation in Biofeedback

A study testing Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy. in people with Constipation and Chronic Constipation, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Constipation, Chronic Constipation, Dyssynergia
What is being tested?: Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy.
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited Kingdom
Study dates: 13 May 2026to 6 Jul 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

dyssynergia, constipation, obstructive defecation

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Hull University Teaching Hospitals
Hull, HU16 5JQ

Other trials in United Kingdom

About this study

Official title: Analysing the Impact of Balloon Inflated vs Balloon Deflated Push Manoeuvres in Chronically Constipated Patients During Biofeedback Therapy

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
Being tested: Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy., No intervention
Keywords: biofeedback
Medical subject headings: Constipation, Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
No interventionOther
The patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.

Study groups in NCT07705542
Study group	Role	What they receive
Balloon deflated on push manoeuvre during biofeedback therapy	Active comparator	Not described Receives: Other: No intervention
Balloon inflated to defecatory desire volume on push manoeuvre during biofeedback therapy	Active comparator	Not described Receives: Other: Inflating anorectal catheter balloon to defecatory desired volume during push manoeuvres in biofeedback therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
1. 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.
Measured: During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 20266 Jul 2026

First posted15 Jul 2026
Study start13 May 2026
Primary completion6 Jul 2026
Study completion6 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for ConstipationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07705542
Sponsor's protocol ID: 367053
Status last verified: Mar 2026
First submitted: 22 Jun 2026
Last updated: 22 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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
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.
PubMed 18023112
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.
PubMed 28660663
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.
PubMed 33893763
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.
PubMed 25828100
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.
PubMed 29996755
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.
PubMed 36950062
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.
PubMed 39506302
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.
PubMed 33536850
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.
PubMed 27144630
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.
PubMed 36919830
Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060.
PubMed 27270989
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.
PubMed 31893959
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.
PubMed 38396390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Analysing the Impact of Balloon Inflated vs Balloon Deflated Push Manoeuvres in Chronically Constipated Patients During Biofeedback Therapy
ClinicalTrials.gov ID: NCT07705542
Acronym / sponsor ID: 367053
Conditions: Constipation, Chronic Constipation, Dyssynergia, Anismus
Keywords: biofeedback
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Hull University Teaching Hospitals NHS TrustOther government
Study start: 13 May 2026 (actual)
Primary completion: 6 Jul 2026 (actual)
Study completion: 6 Jul 2026 (actual)
First posted: 15 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

dyssynergia, constipation, obstructive defecation

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inflating 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.	Other	Balloon inflated to defecatory desire volume on push manoeuvre during biofeedback therapy
No interventionThe patient will do the manoeuvres in the usual way during our clinic appointments which is with the balloon deflated.	Other	Balloon deflated on push manoeuvre during biofeedback therapy

Primary outcome

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.

1 secondary outcome

Patient experience
Time frame: During the study visit; immediately following completion of both balloon conditions during the HRAM biofeedback session.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
BackgroundPicking, 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: PubMed 18023112Park 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.
Background: PubMed 28660663Skardoon 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.
Background: PubMed 33893763Ozkutuk 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.
Background: PubMed 25828100Rao 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.
Background: PubMed 29996755Black 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.
Background: PubMed 36950062Bae 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.
Background: PubMed 39506302Shi 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.
Background: PubMed 33536850Hite 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.
Background: PubMed 27144630Rao 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.
Background: PubMed 36919830Sadeghi 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.
Background: PubMed 27270989Rao SS, Patcharatrakul T. Diagnosis and Treatment of Dyssynergic Defecation. J Neurogastroenterol Motil. 2016 Jul 30;22(3):423-35. doi: 10.5056/jnm16060.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07705542, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.