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NCT02357784 · ClinicalTrials.gov registry record · NA
Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment
A NA study, sponsored by Northwestern University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT02357784 is a NA study that was terminated before completion, run by Northwestern University. The registered enrollment target is 1 participants.
The verdict
NCT02357784, a NA study, was terminated before completion, sponsored by Northwestern University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI. In many situations, DI is the result of a failure of communication between the brain and the sacral nerve, which controls the bladder, bowel, and pelvic floor. The only currently available treatment with level 1 effectiveness data for the treatment of BOTH UI and FI is called Sacral Neuromodulation (SNM). Sacral Neuromodulation is a standard of care treatment that involves surgically implanting a device in to a patient's body to target communication issues between their brain and bladder/bowel. Because the exact mechanism of action of SNM remains unclear, this study aims to better understand how SNM affects the nerves of patients with DI. Patients who are already planning on undergoing SNM device implantation will be recruited to this study. Study participants will undergo Current Perception Threshold (CPT) Testing and fill out questionnaires before SNM and 3 months after their SNM treatment. CPT Testing uses mild electrical stimulation in the urethra and rectum to measure and quantify the amount of physical stimuli required for the nerves in the pelvic floor to sense a stimulus. By learning more about nerve function in patients with DI, the investigators hope to find a way to screen patients before treatment with SNM to make sure the treatment will be effective for that individual.
Interventions
- DEVICE Neurometer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2015-01 |
| Est. Completion | 2018-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02357784
The ClinicalTrials.gov registry entry for NCT02357784 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Neurometer is the first listed.
NCT02357784 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02357784 about?
NCT02357784 is a clinical study titled "Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment". Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI. In many situations, DI is the result of a failure of communication between the brain and t...
What is the current status of trial NCT02357784?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2015-01. Estimated completion is 2018-11.
What interventions are being tested in trial NCT02357784?
The interventions under investigation include: Neurometer (DEVICE).
Who is sponsoring clinical trial NCT02357784?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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