Anal IncontinencePhase 4NCT02550899
Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence
A Phase 4 study testing Transanal submucosal injection group 1, Transanal submucosal injection group 2 and Transanal submucosal injection group 3 in people with Anal Incontinence, run by Karolinska Institutet.
Trial summary
A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anal Incontinence
- What is being tested?
- Transanal submucosal injection group 1, Transanal submucosal injection group 2 and Transanal submucosal injection group 3
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Feb 2014
- Phase
- Phase 4
- 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
- informed consent, anal incontinence with Wexner score >10
Who cannot join
- ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease
About this study
A randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.
Read the detailed description
A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .
Patients with anal incontinence severity Wexner score >7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.
- Conditions
- Anal Incontinence
- Being tested
- Transanal submucosal injection group 1, Transanal submucosal injection group 2, Transanal submucosal injection group 3
- Medical subject headings
- Encopresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal submucosal injection group 1Procedure or surgery
Transanal submucosal injection using an anoscope using four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide
Transanal submucosal injection group 2Procedure or surgery
Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide
Transanal submucosal injection group 3Procedure or surgery
Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide
| Study group | Role | What they receive |
|---|---|---|
| Bulkamid injection treatment group 1 | Active comparator | Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide Receives: Procedure: Transanal submucosal injection group 1 |
| Bulkamid injection treatment group 2 | Active comparator | injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide Receives: Procedure: Transanal submucosal injection group 2 |
| Bulkamid injection treatment group 3 | Active comparator | injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide Receives: Procedure: Transanal submucosal injection group 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wexner overall score
Measured: 1 year
Secondary outcomes (2)
FIQL overall score
Measured: 1 year
Adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal IncontinenceStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Altman, Karolinska Institutet
- Investigators
- Daniel Altman, MD, PhD, Study director, Karolinska Institutet Danderyd Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550899
- Sponsor's protocol ID
- KIDS
- Status last verified
- Jan 2016
- First submitted
- 12 Sep 2015
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyacrylamide Hydrogel Injection Treatment for Anal Incontinence
- ClinicalTrials.gov ID
- NCT02550899
- Acronym / sponsor ID
- KIDS
- Conditions
- Anal Incontinence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 Sep 2015 (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 randomized study to evaluate the safety and effects of transanal submucosal polyacrylamide hydrogel injection therapy for anal incontinence.
Detailed description
A prospective randomized study to assess the use of Bulkamid for anal incontinence using three different transanal injection techniques .
Patients with anal incontinence severity Wexner score >7. Standardised injection treatment at baseline. Clinical status and subjective symptom evaluation (Wexner score and FIQL) at baseline, 2 months, 6 months and 1 year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bulkamid injection treatment group 1 | Active comparator | Procedure: Transanal submucosal injection group 1Injection at four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide |
| Bulkamid injection treatment group 2 | Active comparator | Procedure: Transanal submucosal injection group 2injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide |
| Bulkamid injection treatment group 3 | Active comparator | Procedure: Transanal submucosal injection group 3injection at three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- informed consent, anal incontinence with Wexner score >10
Key exclusion criteria (1 listed)
- ino additional pregnancies, schedule for pelvic organ surgery within 1 year of treatment, current or previous pelvic organ cancer, insulin treated diabetes, inflammatory bowel disease
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 |
|---|---|---|
| Transanal submucosal injection group 1Transanal submucosal injection using an anoscope using four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide | Procedure or surgery | Bulkamid injection treatment group 1 |
| Transanal submucosal injection group 2Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide | Procedure or surgery | Bulkamid injection treatment group 2 |
| Transanal submucosal injection group 3Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide | Procedure or surgery | Bulkamid injection treatment group 3 |
Primary outcome
Wexner overall score
Time frame: 1 year
2 secondary outcomes
FIQL overall score
Time frame: 1 year
Adverse events
Time frame: 1 year
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 12 Jan 2016.
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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.
Daniel Altman, MD, PhD study director
Karolinska Institutet Danderyd Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transanal submucosal injection group 1, Transanal submucosal injection group 2 and Transanal submucosal injection group 3 in people with Anal Incontinence, run by Karolinska Institutet.
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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Wexner overall 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?
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 12 Jan 2016.