Sacral Nerve Modulation in IPAA Patients With Poor Function

NCT ID: NCT05730959

Last Updated: 2023-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2025-12-31

Brief Summary

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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..

Detailed Description

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Conditions

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Stoma Malfunction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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malfunctioning IPAA

Patients with malfunctioning IPAA

Group Type OTHER

Sacral nerve modulation

Intervention Type DEVICE

Implant of nerve stimulator

Interventions

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Sacral nerve modulation

Implant of nerve stimulator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* UC With IPAA
* Bad functional outcome

Exclusion Criteria

* Established treatable cause of malfunction
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Akershus

OTHER

Sponsor Role lead

Responsible Party

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Tom Oresland

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Oresland, PhD

Role: STUDY_CHAIR

University of Oslo

Other Identifiers

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2014/2206

Identifier Type: -

Identifier Source: org_study_id

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