Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
Primary Purpose
Radiation Exposure, Overactive Bladder, Urge Incontinence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reduced radiation fluoroscopy
Conventional fluoroscopy
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Exposure focused on measuring Sacral Neuromodulation, Fluoroscopy
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
Exclusion Criteria:
- neurogenic bladder, BMI >40, or peripheral neuropathy.
Sites / Locations
- Loma Linda University HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Reduced Radiation Fluoroscopy
Conventional Fluoroscopy
Arm Description
Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
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.
Outcomes
Primary Outcome Measures
Radiation Exposure
measure radiation exposure, milligray (mGy)
Secondary Outcome Measures
Optimal lead placement
based on intraoperative motor response
Voiding log (Bladder Record)
Clinical Outcome
Clinical Outcome assessed by validated questionnaire
Inoperative complications
surgery complication
Operative times
minutes
Full Information
NCT ID
NCT04527445
First Posted
August 23, 2020
Last Updated
November 29, 2022
Sponsor
Loma Linda University
1. Study Identification
Unique Protocol Identification Number
NCT04527445
Brief Title
Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
Official Title
Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2020 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Exposure, Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome
Keywords
Sacral Neuromodulation, Fluoroscopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Subjects notified of the arm after the procedure is performed
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reduced Radiation Fluoroscopy
Arm Type
Experimental
Arm Description
Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.
Arm Title
Conventional Fluoroscopy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Reduced radiation fluoroscopy
Intervention Description
See previous information about each arm
Intervention Type
Procedure
Intervention Name(s)
Conventional fluoroscopy
Intervention Description
See previous information about each arm
Primary Outcome Measure Information:
Title
Radiation Exposure
Description
measure radiation exposure, milligray (mGy)
Time Frame
At time of procedure
Secondary Outcome Measure Information:
Title
Optimal lead placement
Description
based on intraoperative motor response
Time Frame
At time of procedure
Title
Voiding log (Bladder Record)
Description
Clinical Outcome
Time Frame
3 months after surgery
Title
Clinical Outcome assessed by validated questionnaire
Time Frame
3 months after surgery
Title
Inoperative complications
Description
surgery complication
Time Frame
At time of procedure
Title
Operative times
Description
minutes
Time Frame
At time of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
Exclusion Criteria:
neurogenic bladder, BMI >40, or peripheral neuropathy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Forrest Jellison, MD
Phone
909 558-2830
Email
fjellison@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Forrest Jellison, MD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Forrest Jellison, MD
Phone
909-558-8724
Email
fjellison@llu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
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