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Sacral Neuromodulation in Neurogenic Patients

Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05688644
Enrollment
100
Registered
2023-01-18
Start date
2021-12-19
Completion date
2024-12-31
Last updated
2023-01-18

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

Conditions

Fecal Incontinence, Neurogenic Bladder, Neurogenic Bowel, Overactive Bladder, Retention, Urinary, Urge Incontinence

Keywords

Sacral Neuromodulation, Neurogenic Bladder, Neurogenic Bowel

Brief summary

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.

Interventions

DEVICEInterStim II

Sacral neuromodulation

Sponsors

Omri Schwarztuch Gildor
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion criteria

* N/A

Design outcomes

Primary

MeasureTime frame
Decrease of at least 50% in number of urge urinary incontinence episodes1 year
Decrease of at least 50% in number of catheterizations per day1 year
Decrease of at least 50% in number of fecal incontinence episodes1 year

Secondary

MeasureTime frame
Number of revision surgeries1 year
number of follow-up visits for programming and/or troubleshooting1 year

Countries

Israel

Outcome results

None listed

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