ConstipationNCT00502957
Biofeedback Treatment for Functional Constipation
A study testing Biofeedback in people with Constipation, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1) anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using relaxation techniques. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Constipation
- What is being tested?
- Biofeedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Nov 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- chronic constipation
- medical recommendation to undergo biofeedback training
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94115
About this study
Official title: Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success
The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1) anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using relaxation techniques.
The study will also examine which medical and psychological factors determine biofeedback success for treating constipation, such as bowel habits, emotional reactions to constipation, and levels of stress and psychological distress.
Read the detailed description
This is a randomized controlled trial (RCT) to evaluate the efficacy of anorectal biofeedback therapy for functional constipation secondary to pelvic floor dyssynergia. Participants will be randomized to either six sessions of anorectal biofeedback or to six sessions of generalized biofeedback.
Participants will complete questionnaires at baseline, at completion of randomized treatment(12 weeks), and six months after completion of treatment to measure change in bowel habits, constipation severity, constipation-related quality of life, and constipation-related disability. An examination of psychosocial factors will also be conducted prior to treatment to distinguish which ones are predictive of biofeedback success for functional constipation.
- Conditions
- Constipation
- Being tested
- Biofeedback
- Keywords
- biofeedback, constipation
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2007 (estimated)
- Study startMar 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Investigators
- Madhulika G Varma, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502957
- Sponsor's protocol ID
- H9654-26326
- Status last verified
- Aug 2009
- First submitted
- 16 Jul 2007
- Last updated
- 25 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hart SL, Lee JW, Berian J, Patterson TR, Del Rosario A, Varma MG. A randomized controlled trial of anorectal biofeedback for constipation. Int J Colorectal Dis. 2012 Apr;27(4):459-66. doi: 10.1007/s00384-011-1355-9. Epub 2011 Dec 9.
PubMed 22159695
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback for Functional Constipation: Efficacy and Predictive Factors of Success
- ClinicalTrials.gov ID
- NCT00502957
- Acronym / sponsor ID
- H9654-26326
- Conditions
- Constipation
- Keywords
- biofeedback, constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 18 Jul 2007 (estimated)
- 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.
The purpose of this randomized, controlled trial is to examine how well biofeedback treatment works to improve constipation. The study is comparing two kinds of biofeedback treatment: 1) anorectal-specific biofeedback therapy and 2) generalized biofeedback therapy using relaxation techniques.
The study will also examine which medical and psychological factors determine biofeedback success for treating constipation, such as bowel habits, emotional reactions to constipation, and levels of stress and psychological distress.
Detailed description
This is a randomized controlled trial (RCT) to evaluate the efficacy of anorectal biofeedback therapy for functional constipation secondary to pelvic floor dyssynergia. Participants will be randomized to either six sessions of anorectal biofeedback or to six sessions of generalized biofeedback.
Participants will complete questionnaires at baseline, at completion of randomized treatment(12 weeks), and six months after completion of treatment to measure change in bowel habits, constipation severity, constipation-related quality of life, and constipation-related disability. An examination of psychosocial factors will also be conducted prior to treatment to distinguish which ones are predictive of biofeedback success for functional constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- chronic constipation
- medical recommendation to undergo biofeedback training
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Biofeedback | Behavioural | – |
Primary outcome
Not reported in the source record.
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 25 Jun 2010.
- Derived from this study: PubMed 22159695Hart SL, Lee JW, Berian J, Patterson TR, Del Rosario A, Varma MG. A randomized controlled trial of anorectal biofeedback for constipation. Int J Colorectal Dis. 2012 Apr;27(4):459-66. doi: 10.1007/s00384-011-1355-9. Epub 2011 Dec 9.
Related trials for Constipation
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effect of Abdominal Massage Training Provided to Caregivers on Constipation Management
Constipation
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
Recruiting
Effect of a Constipation Prevention Checklist in Hip Surgery Patients
Constipation, Perioperative Nursing
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
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.
Madhulika G Varma, MD principal investigator
University of California, San Francisco
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 Constipation, run by University of California, San Francisco at 1 site in United States.
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 2 inclusion and 0 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 25 Jun 2010. 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 States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00502957, which also lists 1 linked publication.
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 25 Jun 2010.