Sacral Nerve Modulation in IPAA Patients With Poor Function

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05730959

Enrollment

Registered

2023-02-16

Start date

2016-01-01

Completion date

2025-12-31

Last updated

2023-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stoma Malfunction

Keywords

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

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..

Interventions

DEVICESacral nerve modulation

Implant of nerve stimulator

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* UC With IPAA * Bad functional outcome

Exclusion criteria

* Established treatable cause of malfunction

Design outcomes

Primary

Measure	Time frame	Description
Øresland Score	12 months	functional score

Secondary

Measure	Time frame	Description
Bowel physiology	At inclusion and at 12 months	Barostat

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026