Neurogenic BladderNCT05688644
Sacral Neuromodulation in Neurogenic Patients
An observational study of Neurogenic Bladder and Neurogenic Bowel, run by Omri Schwarztuch Gildor at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder, Neurogenic Bowel, Urge Incontinence
- What is being tested?
- InterStim II
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 19 Dec 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with approved indication for sacral neuromodulation
Who may be able to join
- Patients who underwent InterStim II advanced evaluation for approved indication
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients
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
- Being tested
- InterStim II
- Keywords
- Sacral Neuromodulation, Neurogenic Bladder, Neurogenic Bowel
- Medical subject headings
- Urinary Bladder, Neurogenic, Neurogenic Bowel, Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Retention, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterStim IIDevice
Sacral neuromodulation
| Study group | Role | What they receive |
|---|---|---|
| Neurogenic Patients | Patients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II Receives: Device: InterStim II | |
| Idiopathic | Patients without underlined relevant neurologic condition, after advanced evaluation of InterStim II Receives: Device: InterStim II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of at least 50% in number of catheterizations per day
Measured: 1 year
Decrease of at least 50% in number of fecal incontinence episodes
Measured: 1 year
Decrease of at least 50% in number of urge urinary incontinence episodes
Measured: 1 year
Secondary outcomes (2)
Number of revision surgeries
Measured: 1 year
number of follow-up visits for programming and/or troubleshooting
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start19 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omri Schwarztuch Gildor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omri Schwarztuch Gildor, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688644
- Sponsor's protocol ID
- MMC-0221-21
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients
- ClinicalTrials.gov ID
- NCT05688644
- Acronym / sponsor ID
- MMC-0221-21
- Conditions
- Neurogenic Bladder, Neurogenic Bowel, Urge Incontinence, Overactive Bladder, Retention, Urinary, Fecal Incontinence
- Keywords
- Sacral Neuromodulation, Neurogenic Bladder, Neurogenic Bowel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Omri Schwarztuch GildorUniversity, hospital or other
- Study start
- 19 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neurogenic Patients | – | Device: InterStim IIPatients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II |
| Idiopathic | – | Device: InterStim IIPatients without underlined relevant neurologic condition, after advanced evaluation of InterStim II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with approved indication for sacral neuromodulation
Key inclusion criteria (1 listed)
- Patients who underwent InterStim II advanced evaluation for approved indication
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterStim IISacral neuromodulation | Device | Idiopathic, Neurogenic Patients |
Primary outcome
Decrease of at least 50% in number of catheterizations per day
Time frame: 1 year
Decrease of at least 50% in number of fecal incontinence episodes
Time frame: 1 year
Decrease of at least 50% in number of urge urinary incontinence episodes
Time frame: 1 year
2 secondary outcomes
Number of revision surgeries
Time frame: 1 year
number of follow-up visits for programming and/or troubleshooting
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder and Neurogenic Bowel, run by Omri Schwarztuch Gildor at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of at least 50% in number of catheterizations per day (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.