Sacral Neuromodulation in Neurogenic Patients

• Sponsor: Omri Schwarztuch Gildor (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05688644
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 36.4
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder; Neurogenic Bowel; Urge Incontinence; Overactive Bladder; Retention, Urinary; Fecal Incontinence	Device: InterStim II

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Efficacy and Safety of Sacral Neuromodulation With InterStim II in Neurogenic Bladder and/or Bowel Patients
• Actual Study Start Date: Dec 19, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Neurogenic Patients Patients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II	Device: InterStim II; Sacral neuromodulation
Idiopathic Patients without underlined relevant neurologic condition, after advanced evaluation of InterStim II	Device: InterStim II; Sacral neuromodulation

Outcome Measures

Primary Outcome Measures

1. Decrease of at least 50% in number of catheterizations per day [1 year]

2. Decrease of at least 50% in number of fecal incontinence episodes [1 year]

3. Decrease of at least 50% in number of urge urinary incontinence episodes [1 year]

Secondary Outcome Measures

1. Number of revision surgeries [1 year]

2. number of follow-up visits for programming and/or troubleshooting [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Meir Medical Center	Kfar-Sava		Israel

Sponsors and Collaborators

• Omri Schwarztuch Gildor

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omri Schwarztuch Gildor, Urologist, Clalit Health Services
• ClinicalTrials.gov Identifier: NCT05688644
• Other Study ID Numbers: MMC-0221-21
• First Posted: Jan 18, 2023
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Omri Schwarztuch Gildor, Urologist, Clalit Health Services: Sacral Neuromodulation; Neurogenic Bladder; Neurogenic Bowel
• Additional relevant MeSH terms: Fecal Incontinence; Neurogenic Bowel; Urinary Bladder, Neurogenic; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Retention

Study Results

No Results Posted as of Jan 18, 2023