Sacral Nerve Modulation in IPAA Patients With Poor Function
Sponsor
University Hospital, Akershus (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05730959
Collaborator
(none)
22
1
120
Study Details
Study Description
Brief 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. After a another 14 days without stimulation the tests will be repeated. Those who respond positively will be offered permanent implantation of the Device..
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
22 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Sacral Nerve Modulation in IPAA Patients With Poor Function
Actual Study Start Date
:
Jan 1, 2016
Anticipated Primary Completion Date
:
Dec 31, 2024
Anticipated Study Completion Date
:
Dec 31, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: malfunctioning IPAA Patients with malfunctioning IPAA |
Device: Sacral nerve modulation
Implant of nerve stimulator
|
Outcome Measures
Primary Outcome Measures
- Øresland Score [12 months]
functional score
Secondary Outcome Measures
- Bowel physiology [At inclusion and at 12 months]
Barostat
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
UC With IPAA
-
Bad functional outcome
Exclusion Criteria:
- Established treatable cause of malfunction
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University Hospital, Akershus
Investigators
- Study Chair: Tom Oresland, PhD, University of Oslo
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tom Oresland,
Clinical professor,
University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT05730959
Other Study ID Numbers:
- 2014/2206
First Posted:
Feb 16, 2023
Last Update Posted:
Feb 16, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tom Oresland,
Clinical professor,
University Hospital, Akershus