Fecal IncontinenceNCT02165475
Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
A study testing Biofeedback, Loperamide and Stool bulking agent (stericulia or isphagula husk) in people with Fecal Incontinence, run by University Hospital, Linkoeping at 1 site in Sweden.
Trial summary
Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments. Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Biofeedback, Loperamide and Stool bulking agent (stericulia or isphagula husk)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteSweden
- Study dates
- May 2002to Mar 2005
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years of age
- Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
- Patients from whom written consent was obtained
Who cannot join
- Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
- Presence of neurological diseases or peripheral vascular disease
- Uncontrolled diabetes mellitus
- Congenital anorectal malformations
- Recent colorectal or gastrointestinal surgery
- Presence of external full-thickness rectal prolapse
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- Inflammatory bowel disease
- Chronic diarrhoea
- Use of tibial nerve or sacral nerve stimulations
- Ongoing pregnancy
- Any malignant disease
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Pelvic floor unit, University hospital of Linköping
Linköping, 58185
About this study
Official title: Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial
Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments.
Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination.
Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.
- Conditions
- Fecal Incontinence
- Being tested
- Biofeedback, Loperamide, Stool bulking agent (stericulia or isphagula husk), Combination of biofeedback and medical treatment
- Medical subject headings
- Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
LoperamideDrug
Stool bulking agent (stericulia or isphagula husk)Drug
Combination of biofeedback and medical treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | Not described Receives: Behavioral: Biofeedback |
| medical treatment | Experimental | Not described Receives: Drug: Loperamide; Drug: Stool bulking agent (stericulia or isphagula husk) |
| combination of the two treatments | Experimental | Not described Receives: Other: Combination of biofeedback and medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom diary
Measured: Up to eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startMay 2002
- Primary completionMar 2005
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 N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Sjödahl, University Hospital, Linkoeping
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165475
- Sponsor's protocol ID
- Dnr 02-220
- Status last verified
- Jun 2014
- First submitted
- 11 Jun 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents is Effective for the Treatment of Fecal Incontinence in Women - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02165475
- Acronym / sponsor ID
- Dnr 02-220
- Conditions
- Fecal Incontinence
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Mar 2005 (actual)
- First posted
- 17 Jun 2014 (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.
Background: Biofeedback and medical treatments have been extensively used for moderate fecal incontinence. There is limited data comparing and combining these two treatments.
Aim: To evaluate the effect of biofeedback and medical treatments, separately and in combination.
Methods: Sixty-five consecutive female patients, referred to a tertial center for fecal incontinence were included. The patients were randomized to start with either biofeedback (4-6 months) or medical treatment with loperamide and stool-bulking agents (2 months). Both groups continued with a combination treatments, i.e. medical treatment was added to biofeedback and vice versa. A two-week prospective bowel symptom diary and anorectal physiology were evaluated at baseline, after single- and combination treatments.
Study design
- Primary purpose
- Treatment
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: Biofeedback |
| medical treatment | Experimental | Drug: Loperamide, Drug: Stool bulking agent (stericulia or isphagula husk) |
| combination of the two treatments | Experimental | Other: Combination of biofeedback and medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than 18 years of age
- Patients with at least one or more episodes of FI during a period of 2 weeks as recorded by bowel function diary
- Patients from whom written consent was obtained
Key exclusion criteria (11 listed)
- Previous congenital or acquired spinal injury, spinal tumour or spinal surgery
- Presence of neurological diseases or peripheral vascular disease
- Uncontrolled diabetes mellitus
- Congenital anorectal malformations
- Recent colorectal or gastrointestinal surgery
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 | Biofeedback |
| Loperamide | Drug | medical treatment |
| Stool bulking agent (stericulia or isphagula husk) | Drug | medical treatment |
| Combination of biofeedback and medical treatment | Other | combination of the two treatments |
Primary outcome
symptom diary
Time frame: Up to eight months
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 18 Jun 2014.
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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?
A study testing Biofeedback, Loperamide and Stool bulking agent (stericulia or isphagula husk) in people with Fecal Incontinence, run by University Hospital, Linkoeping at 1 site in Sweden.
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 3 inclusion and 11 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 18 Jun 2014. 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 Sweden. 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?
symptom diary (time frame: Up to eight months). 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 18 Jun 2014.