Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Reduced radiation fluoroscopy, Conventional fluoroscopy.
- Who it may be relevant to
- Registry conditions: Radiation Exposure, Overactive Bladder, Urge Incontinence, Urgency-frequency Syndrome. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study
Overview
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.
Interventions
- Procedure Reduced radiation fluoroscopy
See previous information about each arm - Procedure Conventional fluoroscopy
See previous information about each arm
Primary outcome measures
- Radiation Exposure [Time frame: At time of procedure]
Secondary outcome measures (5)
- Optimal lead placement [Time frame: At time of procedure]
- Voiding log (Bladder Record) [Time frame: 3 months after surgery]
- Clinical Outcome assessed by validated questionnaire [Time frame: 3 months after surgery]
- Inoperative complications [Time frame: At time of procedure]
- Operative times [Time frame: At time of procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Loma Linda University Health — Loma Linda
Identifiers
NCT: NCT04527445 · 5200182