Rectal NeoplasmsNCT00515853

The Role of Biofeedback in Improving Continence After Anterior Resection

A study testing Biofeedback in people with Rectal Neoplasms and Fecal Incontinence, run by University of Southampton 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

Search all trials

Trial summary

The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rectal Neoplasms, Fecal Incontinence, Aged
What is being tested?: Biofeedback
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 121 participants
Where: 1 siteUnited Kingdom
Study dates: 27 Nov 2006to 13 May 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Rectosigmoid or rectal cancer

Who cannot join

Inoperable

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Southampton General Hospital
Southampton, Hampshire, SO16 6YD

Other trials in United Kingdom

About this study

The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

Read the detailed description

See above

Conditions: Rectal Neoplasms, Fecal Incontinence, Aged
Being tested: Biofeedback
Keywords: Rectal neoplasms, Biofeedback (Psychology), Fecal Incontinence, Aged, Anterior resection
Medical subject headings: Rectal Neoplasms, Fecal Incontinence

What participants receive

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

BiofeedbackBehavioural
Biofeedback sessions or biofeedback exercises

Study groups in NCT00515853
Study group	Role	What they receive
Biofeedback	Experimental	Received feedback Receives: Behavioral: Biofeedback
No biofeedback	No intervention	Did not received feedback

What is being measured

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

Cleveland Clinic Incontinence (CCI) Score
The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence.
Measured: 1 year

Timeline

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

27 Nov 200613 May 2010

First posted14 Aug 2007 (estimated)
Study start27 Nov 2006
Primary completion13 May 2010
Study completion13 May 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rectal NeoplasmsStudies 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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 121 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00515853
Sponsor's protocol ID: RHM GSU 0132
Status last verified: Jan 2022
First submitted: 10 Aug 2007
Last updated: 7 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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?

See locations

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

All Rectal Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Biofeedback in Improving Continence After Anterior Resection
ClinicalTrials.gov ID: NCT00515853
Acronym / sponsor ID: RHM GSU 0132
Conditions: Rectal Neoplasms, Fecal Incontinence, Aged
Keywords: Rectal neoplasms, Biofeedback (Psychology), Fecal Incontinence, Aged, Anterior resection
Study type: Interventional
Recruitment status: Completed
Enrolment: 121 participants (actual)
Lead sponsor: University of SouthamptonUniversity, hospital or other
Study start: 27 Nov 2006 (actual)
Primary completion: 13 May 2010 (actual)
Study completion: 13 May 2010 (actual)
First posted: 14 Aug 2007 (estimated)
Results: Posted 7 Mar 2022

Clinical summary

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

The purpose of this study is to determine whether biofeedback exercises improve anal continence after anterior resection for rectal cancer.

Detailed description

See above

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Biofeedback	Experimental	Behavioral: BiofeedbackReceived feedback
No biofeedback	No intervention	–Did not received feedback

Who may qualify

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

Key inclusion criteria (1 listed)

Rectosigmoid or rectal cancer

Key exclusion criteria (1 listed)

Inoperable

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
BiofeedbackBiofeedback sessions or biofeedback exercises	Behavioural	Biofeedback

Primary outcome

Cleveland Clinic Incontinence (CCI) Score
Time frame: 1 year
The Cleveland Clinic incontinence score (CCI) is an anal incontinence severity score. It is easy to use and gives the patient a score of 0 to 20, where zero equates to perfect continence and twenty equates to complete anal incontinence.

Results and safety

Results posted to the registry on 7 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Biofeedback	61	46
No Biofeedback	60	43

Primary outcome: Cleveland Clinic Incontinence (CCI) Score

Time frame: 1 year. Mean (Standard Deviation). Unit: score on a scale

Measure	Biofeedback n = 43	No Biofeedback n = 46
CCI final	4.2 (4.2)	3.7 (3.5)
Adjusted CCI final	1.2 (6.0)	-0.7 (5.5)

Biofeedback vs No Biofeedback: p = 0.54, Regression, Linear

Population analysed: Analyzed participants, less than the randomized participants

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Biofeedback	5 of 61 (8.2%)	0 of 61 (0%)	1 of 61
No Biofeedback	7 of 60 (11.7%)	0 of 60 (0%)	4 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Rectal Neoplasms

Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer

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.

S A Pilkington principal investigator

Southampton University

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

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback in people with Rectal Neoplasms and Fecal Incontinence, run by University of Southampton at 1 site in United Kingdom.

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 1 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 7 Mar 2022. 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?

Yes. Results are posted in the registry (first posted 7 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Cleveland Clinic Incontinence (CCI) Score (time frame: 1 year). 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 NCT00515853.

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 7 Mar 2022.