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Fluoroscopy is performed when placing a lead during a sacral neuromodulation procedure. During lead placement, subjects will receive either conventional or experimental fluoroscopic settings. The radiation exposure will be compared between the two groups.
Patients scheduled for lead implantation during sacral neuromodulation in the operating room and consent will be included in this study. Placement of the lead in the operating room with fluoroscopy is the standard of care in this procedure. Fluoroscopy is performed with a C-arm and there are settings that change the radiation exposure. Patients scheduled to undergo lead placement will be randomized to: a) the investigational (reduced radiation with fluoroscopic settings) or b. the control (conventional fluoroscopy).
The surgeon can change fluoroscopy radiation exposure by changing C-arm settings from the reduced radiation to conventional fluoroscopic options. During the surgery, the surgeon may change the settings from reduced radiation (intervention) to conventional fluoroscopy (control) to safely place lead. The surgeon will use their judgment to optimally place lead and maintain safety during placement. Any deviation from randomization will be recorded.
The intervention arm is defined: Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
The control arm is defined: The standard of care in the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set at the default.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced Radiation Fluoroscopy | Experimental | Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current. |
|
| Conventional Fluoroscopy | Active Comparator | The standard of care is the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set as the default. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced radiation fluoroscopy | Procedure | See previous information about each arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Radiation Exposure | measure radiation exposure, milligray (mGy) | At time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal lead placement | based on intraoperative motor response | At time of procedure |
| Voiding log (Bladder Record) | Clinical Outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Forrest Jellison, MD | Contact | 909 558-2830 | fjellison@llu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Forrest Jellison, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Health | Recruiting | Loma Linda | California | 92354 | United States |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Subjects notified of the arm after the procedure is performed
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| Conventional fluoroscopy | Procedure | See previous information about each arm |
|
| 3 months after surgery |
| Clinical Outcome assessed by validated questionnaire | 3 months after surgery |
| Inoperative complications | surgery complication | At time of procedure |
| Operative times | minutes | At time of procedure |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |