Fecal IncontinencePhase 4NCT03746834
NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
A Phase 4 study testing NASHA/Dx (Solesta®) in people with Fecal Incontinence and Anorectal Malformation, run by Uppsala University.
Trial summary
Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fecal Incontinence, Anorectal Malformation
- What is being tested?
- NASHA/Dx (Solesta®)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2013to 12 Dec 2015
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistent FI (Miller incontinence score >5)
- Anorectal malformation.
Who cannot join
- Pregnancy
- Rectal prolapse
- Significant mucosal prolapse
- Inflammatory bowel disease
- Anorectal surgery within the last year Before inclusion
- Anticoagulant medication/bleeding diathesis
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- Anorectal sepsis in the past
- Immunodeficiency
- Immunosuppressing therapy
About this study
Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy.
The study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.
- Conditions
- Fecal Incontinence, Anorectal Malformation
- Being tested
- NASHA/Dx (Solesta®)
- Keywords
- Fecal incontinence, Anorectal malformation
- Medical subject headings
- Fecal Incontinence, Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NASHA/Dx (Solesta®)Device
Perianal submucosal injection of 3-4 ml of NASHA/Dx
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Patients are given NASHA/Dx as a perianal injection Receives: Device: NASHA/Dx (Solesta®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of incontinence episodes
The number of incontinences episodes as measured over a two week interval The number of incontience episodes is measured with a bowel-movement-diary over a two week period.
Measured: The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.
Secondary outcomes (4)
Miller´s incontinence score
Change of Miller´s incontinence score
Measured: Before treatment compared with data at 18 months after treatment. Miller´s incontinence score is measured on a scale from 0 (meaning total fecal continence) to 18 (meaning total fecal incontinence).
Quality of life, general
Change in quality of Life as observed with SF-36
Measured: Before treatment compared with data at 18 months after treatment. SF-36 measures quality of life in 8 subscales. Each scaled from 0 to 100. Higher score is considered better. Two total scores of mental and physical QoL can be calculated.
Adverse events
Control of any adverse events during the course of the study
Measured: Before treatment compared with data at 18 months after treatment
Quality of life, disease specific
Change in quality of Life as observed with FIQL
Measured: Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start20 Sep 2013
- Primary completion12 Dec 2015
- Study completion12 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients are treated with injection of NASHA/Dx and act as their own Controls over time.
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Danielson, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746834
- Sponsor's protocol ID
- 461:2013/6500
- Status last verified
- Nov 2018
- First submitted
- 2 May 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data collected is of very personal type and since the number of subjects is so small there would be a risk of identification if all the data was released.
Publications
Danielson J, Karlbom U, Wester T, Graf W. Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents. Tech Coloproctol. 2013 Aug;17(4):389-95. doi: 10.1007/s10151-012-0949-8. Epub 2012 Dec 7.
PubMed 23224913Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.
PubMed 19581853Danielson J, Karlbom U, Graf W, Wester T. Outcome in adults with anorectal malformations in relation to modern classification - Which patients do we need to follow beyond childhood? J Pediatr Surg. 2017 Mar;52(3):463-468. doi: 10.1016/j.jpedsurg.2016.10.051. Epub 2016 Nov 15.
PubMed 27894765
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NASHA/Dx as a Perianal Implant for the Treatment of Persistent Fecal Incontience After Anorectal Malformation
- ClinicalTrials.gov ID
- NCT03746834
- Acronym / sponsor ID
- 461:2013/6500
- Conditions
- Fecal Incontinence, Anorectal Malformation
- Keywords
- Fecal incontinence, Anorectal malformation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 20 Sep 2013 (actual)
- Primary completion
- 12 Dec 2015 (actual)
- Study completion
- 12 Dec 2015 (actual)
- First posted
- 20 Nov 2018 (actual)
- 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.
Persistent fecal incontinence (FI) after anorectal malformations (ARM) is a common occurence. During the last two decades perianal injection therapy has emerged as an option for treating patients with FI due to other causes than ARMs. The studies done on different implants have always expempted patients with ARM which has led to ARM being a formal contraindication for treatment with perianal injection therapy.
The study aims to treat patients with persistent FI after ARM with perianal injection of NASHA/Dx (Solesta®) and follow them with Clinical examination and questionnaires up to 18 months post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients are treated with injection of NASHA/Dx and act as their own Controls over time.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Device: NASHA/Dx (Solesta®)Patients are given NASHA/Dx as a perianal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Persistent FI (Miller incontinence score >5)
- Anorectal malformation.
Key exclusion criteria (9 listed)
- Pregnancy
- Rectal prolapse
- Significant mucosal prolapse
- Inflammatory bowel disease
- Anorectal surgery within the last year Before inclusion
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 |
|---|---|---|
| NASHA/Dx (Solesta®)Perianal submucosal injection of 3-4 ml of NASHA/Dx | Device | Treatment arm |
Primary outcome
Change in number of incontinence episodes
Time frame: The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.
The number of incontinences episodes as measured over a two week interval The number of incontience episodes is measured with a bowel-movement-diary over a two week period.
4 secondary outcomes
Miller´s incontinence score
Time frame: Before treatment compared with data at 18 months after treatment. Miller´s incontinence score is measured on a scale from 0 (meaning total fecal continence) to 18 (meaning total fecal incontinence).
Quality of life, general
Time frame: Before treatment compared with data at 18 months after treatment. SF-36 measures quality of life in 8 subscales. Each scaled from 0 to 100. Higher score is considered better. Two total scores of mental and physical QoL can be calculated.
Adverse events
Time frame: Before treatment compared with data at 18 months after treatment
Quality of life, disease specific
Time frame: Before treatment compared with data at 18 months after treatment. Measures 4 subscales, each measuring 1-4. Higher score implies better quality of life.
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 20 Nov 2018.
- Results publication: PubMed 23224913Danielson J, Karlbom U, Wester T, Graf W. Efficacy and quality of life 2 years after treatment for faecal incontinence with injectable bulking agents. Tech Coloproctol. 2013 Aug;17(4):389-95. doi: 10.1007/s10151-012-0949-8. Epub 2012 Dec 7.
- Results publication: PubMed 19581853Danielson J, Karlbom U, Sonesson AC, Wester T, Graf W. Submucosal injection of stabilized nonanimal hyaluronic acid with dextranomer: a new treatment option for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1101-6. doi: 10.1007/DCR.0b013e31819f5cbf.
- Results publication: PubMed 27894765Danielson J, Karlbom U, Graf W, Wester T. Outcome in adults with anorectal malformations in relation to modern classification - Which patients do we need to follow beyond childhood? J Pediatr Surg. 2017 Mar;52(3):463-468. doi: 10.1016/j.jpedsurg.2016.10.051. Epub 2016 Nov 15.
- Individual participant dataSharing planned: No. The data collected is of very personal type and since the number of subjects is so small there would be a risk of identification if all the data was released.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NASHA/Dx (Solesta®) in people with Fecal Incontinence and Anorectal Malformation, run by Uppsala University.
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 9 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 20 Nov 2018. 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?
Change in number of incontinence episodes (time frame: The change in number of incontinence episodes before treatment is compared with data at 18 months after injection.). 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 NCT03746834, which also lists 3 linked publications.
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 20 Nov 2018.