Sacral Neuromodulation in Neurogenic Patients

Omri Schwarztuch Gildor

Status: Invitation-only

Conditions: Neurogenic Bowel; Fecal Incontinence; Retention, Urinary; Neurogenic Bladder; Overactive Bladder; Urge Incontinence

Treatments: Device: InterStim II

Study type: Observational

Funder types: Other

Identifiers

NCT05688644

MMC-0221-21

Details and patient eligibility

About

The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. [. The main question[s] it aims to answer are:

• determine efficacy and safety of the therapy in neurogenic patients.
• compare outcomes of the therapy to idiopathic patients.

If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion criteria

• N/A

Trial design

100 participants in 2 patient groups

Neurogenic Patients

Description:

Patients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II

Treatment:

Device: InterStim II

Idiopathic

Description:

Patients without underlined relevant neurologic condition, after advanced evaluation of InterStim II

Treatment:

Device: InterStim II