Sacral Neuromodulation in Neurogenic Patients

NCT05688644 | Unknown FDA Device

• 1 other identifier: MMC-0221-21
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Sacral Neuromodulation; Neurogenic Bladder; Neurogenic Bowel

Outcome Measures

Primary Outcomes (3)

• Decrease of at least 50% in number of catheterizations per day

  1 year

• Decrease of at least 50% in number of fecal incontinence episodes

  1 year

• Decrease of at least 50% in number of urge urinary incontinence episodes

  1 year

Secondary Outcomes (2)

• Number of revision surgeries

  1 year

• number of follow-up visits for programming and/or troubleshooting

  1 year

Study Arms (2)

Neurogenic Patients

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

Device: InterStim II

Idiopathic

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

Device: InterStim II

Interventions

InterStim II DEVICE

Sacral neuromodulation

Idiopathic; Neurogenic Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with approved indication for sacral neuromodulation

You may qualify if:

• Patients who underwent InterStim II advanced evaluation for approved indication

You may not qualify if:

• N/A

Sponsors & Collaborators

• Omri Schwarztuch Gildor: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Urinary Incontinence; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Urologist

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 18, 2023
• Study Start: December 19, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)