Fecal IncontinencePhase 1NCT00303030
A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence
A Phase 1 study testing 1. Anal injection and 2. Biofeedback in people with Fecal Incontinence, run by University Hospital of North Norway at 3 sites in Norway.
Trial summary
A short presentation of a randomized clinical trial of biofeedback and anal injections as a first treatment option of faecal incontinence. Background: Faecal incontinence affects mainly women who have suffered sphincter disruption from vaginal delivery, but individuals of all ages can be affected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- 1. Anal injection and 2. Biofeedback
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 3 sitesNorway
- Study dates
- May 2006to Jun 2011
- Phase
- Phase 1
- 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
- Fecal incontinence lasting more than 6 months
- St. Marks score of 4 or more
- No known local or general neurological disease
- 18 years or older
- No constipation
Who cannot join
- Total rupture of the sphincter of more than 120 degrees
- Diabetes mellitus with late complications (neurological og cardiovascular)
- Ulcus simplex/rectal ulcus
- Anal/rectal prolapse
- ileo-anal anastomosis
- Cancer recti or cancer ani last 2 years
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
Norway3 sites
Innlandssykehuset Hamar
Hamar
Anorektallaboratoriet, Østfoldsykehuset Sarpsborg
Sarpsborg, 1723
Avdeling for gastroenterologisk kirurgi, University hospital of North Norway
Tromsø, 9016
About this study
Official title: A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence.
A short presentation of a randomized clinical trial of biofeedback and anal injections as a first treatment option of faecal incontinence.
Background: Faecal incontinence affects mainly women who have suffered sphincter disruption from vaginal delivery, but individuals of all ages can be affected. The treatment of this debility is not uniform between institutions or internationally. Often is surgical reconstruction of the anal sphincter performed, or other invasive, costly treatment options.
Read more
The study: We intend to conduct a randomized, controlled, clinical trial where we compare the effect of two less invasive, less costly treatment options as a first alternative: biofeedback and anal injections. Our hypothesis is that anal injections will give a better and more lasting effect than biofeedback. The primary endpoint will be change in faecal incontinence assessed by the St. Marks incontinence score. Secondary endpoints will include change in quality of life and several physiological parameters. We intend to include 62 patients in both groups, 124 all together, from 2 centres in Norway. The observation time is 2 years. We plan to include the first patient April 2006, and conclude the study by December 2010. This study can contribute to a more appropriate treatment-algorithm for these patients.
Study group:
- Barthold Vonen MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
- Rolv-Ole Lindsetmo MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
- Arvid Stordahl MD PhD., Department of Surgery, Østfold Hospital Fredrikstad
- Ylva Sahlin MD PhD, Department of Surgery, Innlandet Hospital Hamar
- Trond Dehli, MD, Department of gastroenterological surgery, University Hospital of North Norway
- Kjersti Mevik, Stud. Med, University of Tromso
Project manager: Trond Dehli
Funding, approvals, publication: This study is funded from Northern Norway Regional Health Authority and The Institution of Norwegian Health- and rehabilitation-organizations. It has been approved by the Regional Committee for Medical Research Ethics and Norwegian Social Science Data Services. The results will be published in an international peer-reviewed journal after the Vancouver-convention's guidelines. The results will also be presented at national and international conferences.
Contact:
Trond Dehli, Department of gastroenterological surgery, University hospital North Norway, Breivika, 9038 Tromsø trond.dehli@unn.no tlf: +47 776 26 000
- Conditions
- Fecal Incontinence
- Being tested
- 1. Anal injection, 2. Biofeedback
- Keywords
- Fecal incontinence, Biofeedback, Patient Satisfaction, Quality of LifeTreatment Outcome, Injections
- Medical subject headings
- Fecal Incontinence, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Anal injectionProcedure or surgery
Also called Solesta
Submucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere.
2. BiofeedbackProcedure or surgery
Training under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe.
| Study group | Role | What they receive |
|---|---|---|
| 1. Anal injection | Active comparator | Not described Receives: Procedure: 1. Anal injection |
| 2. Biofeedback | Active comparator | Not described Receives: Procedure: 2. Biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incontinence measured by St.Marks incontinence score
Measured: 2 years
Secondary outcomes (2)
Health related Quality of Life measures
Measured: 2 years
Physiologic measures
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMay 2006
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Barthold Vonen, M.D., Ph.D., Study director, University of Tromsø, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303030
- Sponsor's protocol ID
- Biofeedback or injections
- Status last verified
- Nov 2011
- First submitted
- 14 Mar 2006
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Clinical Trial of Biofeedback and Anal Injections as First Treatment of Fecal Incontinence.
- ClinicalTrials.gov ID
- NCT00303030
- Acronym / sponsor ID
- Biofeedback or injections
- Conditions
- Fecal Incontinence
- Keywords
- Fecal incontinence, Biofeedback, Patient Satisfaction, Quality of LifeTreatment Outcome, Injections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Norwegian Foundation for Health and Rehabilitation
- Study start
- May 2006
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Mar 2006 (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.
A short presentation of a randomized clinical trial of biofeedback and anal injections as a first treatment option of faecal incontinence.
Background: Faecal incontinence affects mainly women who have suffered sphincter disruption from vaginal delivery, but individuals of all ages can be affected. The treatment of this debility is not uniform between institutions or internationally. Often is surgical reconstruction of the anal sphincter performed, or other invasive, costly treatment options.
The study: We intend to conduct a randomized, controlled, clinical trial where we compare the effect of two less invasive, less costly treatment options as a first alternative: biofeedback and anal injections. Our hypothesis is that anal injections will give a better and more lasting effect than biofeedback. The primary endpoint will be change in faecal incontinence assessed by the St. Marks incontinence score. Secondary endpoints will include change in quality of life and several physiological parameters. We intend to include 62 patients in both groups, 124 all together, from 2 centres in Norway. The observation time is 2 years. We plan to include the first patient April 2006, and conclude the study by December 2010. This study can contribute to a more appropriate treatment-algorithm for these patients.
Study group:
- Barthold Vonen MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
- Rolv-Ole Lindsetmo MD PhD, Department of gastroenterological surgery, University Hospital of North Norway
- Arvid Stordahl MD PhD., Department of Surgery, Østfold Hospital Fredrikstad
- Ylva Sahlin MD PhD, Department of Surgery, Innlandet Hospital Hamar
- Trond Dehli, MD, Department of gastroenterological surgery, University Hospital of North Norway
- Kjersti Mevik, Stud. Med, University of Tromso
Project manager: Trond Dehli
Funding, approvals, publication: This study is funded from Northern Norway Regional Health Authority and The Institution of Norwegian Health- and rehabilitation-organizations. It has been approved by the Regional Committee for Medical Research Ethics and Norwegian Social Science Data Services. The results will be published in an international peer-reviewed journal after the Vancouver-convention's guidelines. The results will also be presented at national and international conferences.
Contact:
Trond Dehli, Department of gastroenterological surgery, University hospital North Norway, Breivika, 9038 Tromsø trond.dehli@unn.no tlf: +47 776 26 000
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Anal injection | Active comparator | Procedure: 1. Anal injection |
| 2. Biofeedback | Active comparator | Procedure: 2. Biofeedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Fecal incontinence lasting more than 6 months
- St. Marks score of 4 or more
- No known local or general neurological disease
- 18 years or older
- No constipation
Key exclusion criteria (7 listed)
- Total rupture of the sphincter of more than 120 degrees
- Diabetes mellitus with late complications (neurological og cardiovascular)
- Ulcus simplex/rectal ulcus
- Anal/rectal prolapse
- ileo-anal anastomosis
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 |
|---|---|---|
| 1. Anal injectionAlso: SolestaSubmucosal injection just above the linea dentata in the anal canal of 4 x 1 ml of dextranomere. | Procedure or surgery | 1. Anal injection |
| 2. BiofeedbackTraining under the guidance of a physiotherapist with the help of a biofeedback device with an anal probe. | Procedure or surgery | 2. Biofeedback |
Primary outcome
Incontinence measured by St.Marks incontinence score
Time frame: 2 years
2 secondary outcomes
Health related Quality of Life measures
Time frame: 2 years
Physiologic measures
Time frame: 2 years
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 17 Nov 2011.
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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.
Barthold Vonen, M.D., Ph.D. study director
University of Tromsø, Norway
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1. Anal injection and 2. Biofeedback in people with Fecal Incontinence, run by University Hospital of North Norway at 3 sites in Norway.
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 5 inclusion and 7 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 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Incontinence measured by St.Marks incontinence score (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2011.