Stoma MalfunctionNCT05730959
Sacral Nerve Modulation in IPAA Patients With Poor Function
A study testing Sacral nerve modulation in people with Stoma Malfunction, run by University Hospital, Akershus.
Trial summary
IPAA patients with poor functional outcome where no obvious reason can be detected are identified from our patient registry. These patients are offered a sacral nerve modulation test period of three weeks. They will then be scored on function and physiological testing will be done by a Barostat. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stoma Malfunction
- What is being tested?
- Sacral nerve modulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2025
- 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
- UC With IPAA
- Bad functional outcome
Who cannot join
- Established treatable cause of malfunction
About this study
IPAA patients with poor functional outcome where no obvious reason can be detected are identified from our patient registry. These patients are offered a sacral nerve modulation test period of three weeks. They will then be scored on function and physiological testing will be done by a Barostat. After a another 14 days without stimulation the tests will be repeated. Those who respond positively will be offered permanent implantation of the Device..
- Conditions
- Stoma Malfunction
- Being tested
- Sacral nerve modulation
- Keywords
- IPAA (Ileal Pouch-Anal Anastomosis), SNM (Sacral Nerve Modultion)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacral nerve modulationDevice
Implant of nerve stimulator
| Study group | Role | What they receive |
|---|---|---|
| malfunctioning IPAA | Other | Patients with malfunctioning IPAA Receives: Device: Sacral nerve modulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Øresland Score
functional score
Measured: 12 months
Secondary outcomes (1)
Bowel physiology
Barostat
Measured: At inclusion and at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Jan 2016
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma MalfunctionStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Oresland, University Hospital, Akershus
- Investigators
- Tom Oresland, PhD, Study chair, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730959
- Sponsor's protocol ID
- 2014/2206
- Status last verified
- Feb 2023
- First submitted
- 30 Apr 2019
- Last updated
- 16 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacral Nerve Modulation in IPAA Patients With Poor Function
- ClinicalTrials.gov ID
- NCT05730959
- Acronym / sponsor ID
- 2014/2206
- Conditions
- Stoma Malfunction
- Keywords
- IPAA (Ileal Pouch-Anal Anastomosis), SNM (Sacral Nerve Modultion)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Feb 2023 (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.
IPAA patients with poor functional outcome where no obvious reason can be detected are identified from our patient registry. These patients are offered a sacral nerve modulation test period of three weeks. They will then be scored on function and physiological testing will be done by a Barostat. After a another 14 days without stimulation the tests will be repeated. Those who respond positively will be offered permanent implantation of the Device..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| malfunctioning IPAA | Other | Device: Sacral nerve modulationPatients with malfunctioning IPAA |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- UC With IPAA
- Bad functional outcome
Key exclusion criteria (1 listed)
- Established treatable cause of malfunction
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 |
|---|---|---|
| Sacral nerve modulationImplant of nerve stimulator | Device | malfunctioning IPAA |
Primary outcome
Øresland Score
Time frame: 12 months
functional score
1 secondary outcome
Bowel physiology
Time frame: At inclusion and at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Stoma Malfunction
RecruitingObservational study
Para Versus Trans Rectus Stoma Placement for Prevention of Stoma Related Complications
Stoma Malfunction
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.
Tom Oresland, PhD study chair
University of Oslo
Questions about this trial
What is this clinical trial studying?
A study testing Sacral nerve modulation in people with Stoma Malfunction, run by University Hospital, Akershus.
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 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: status not confirmed, as of the sponsor's last update on 16 Feb 2023. 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.
Are results available for this study?
Results are not available in the source record.
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?
Øresland Score (time frame: 12 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 16 Feb 2023.