Sacral Nerve Modulation in IPAA Patients With Poor Function

February 15, 2023 updated by: Tom Oresland, University Hospital, Akershus
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • UC With IPAA
  • Bad functional outcome

Exclusion Criteria:

  • Established treatable cause of malfunction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: malfunctioning IPAA
Patients with malfunctioning IPAA
Device: Sacral nerve modulation
Implant of nerve stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Øresland Score
Time Frame: 12 months
functional score
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel physiology
Time Frame: At inclusion and at 12 months
Barostat
At inclusion and at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Akershus

Investigators

  • Study Chair: Tom Oresland, PhD, University of Oslo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 30, 2019

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Estimate)

February 16, 2023

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014/2206

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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