NCT05730959

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..

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2019

Completed
3.8 years until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

9 years

First QC Date

April 30, 2019

Last Update Submit

February 15, 2023

Conditions

Stoma Malfunction

Keywords

IPAA (Ileal Pouch-Anal Anastomosis)SNM (Sacral Nerve Modultion)

Outcome Measures

Primary Outcomes (1)

  • Øresland Score

    functional score

    12 months

Secondary Outcomes (1)

  • Bowel physiology

    At inclusion and at 12 months

Study Arms (1)

malfunctioning IPAA

OTHER

Patients with malfunctioning IPAA

Device: Sacral nerve modulation

Interventions

Sacral nerve modulationDEVICE

Implant of nerve stimulator

malfunctioning IPAA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • UC With IPAA
  • Bad functional outcome

You may not qualify if:

  • Established treatable cause of malfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Tom Oresland, PhD

    University of Oslo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

April 30, 2019

First Posted

February 16, 2023

Study Start

January 1, 2016

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

February 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share