Trials / Unknown
UnknownNCT05688644
Sacral Neuromodulation in Neurogenic Patients
Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Omri Schwarztuch Gildor · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Neurogenic Bladder
- Neurogenic Bowel
- Urge Incontinence
- Overactive Bladder
- Retention, Urinary
- Fecal Incontinence
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InterStim II | Sacral neuromodulation |
Timeline
- Start date
- 2021-12-19
- Primary completion
- 2023-12-31
- Completion
- 2024-12-31
- First posted
- 2023-01-18
- Last updated
- 2023-01-18
Locations
1 site across 1 country: Israel
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05688644. Inclusion in this directory is not an endorsement.