Clinical trial NCT04527445: 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
Overall status: RECRUITING
Phase: NA
Conditions: Radiation Exposure
Overactive Bladder
Urge Incontinence
Urgency-frequency Syndrome
Keywords: Sacral Neuromodulation
Fluoroscopy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2020-08-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Radiation Exposure
timeFrame: At time of procedure
Secondary outcomes:
measure: Optimal lead placement
timeFrame: At time of procedure
measure: Voiding log (Bladder Record)
timeFrame: 3 months after surgery
measure: Clinical Outcome assessed by validated questionnaire
timeFrame: 3 months after surgery
measure: Inoperative complications
timeFrame: At time of procedure
measure: Operative times
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University
name: Forrest Jellison, MD
role: PRINCIPAL_INVESTIGATOR
References: