Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Overactive Bladder Clinical Trial

Official title:

Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04527445
• Other study ID #: 5200182
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Loma Linda University
• Contact: Forrest Jellison, MD
• Phone: 909 558-2830
• Email: fjellison[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Radiation Exposure
• Urge Incontinence
• Urgency-frequency Syndrome
• Urinary Bladder, Overactive
• Urinary Incontinence, Urge

Intervention

Procedure:
• Reduced radiation fluoroscopy
See previous information about each arm
• Conventional fluoroscopy
See previous information about each arm

Locations

Country	Name	City	State
United States	Loma Linda University Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Exposure	measure radiation exposure, milligray (mGy)	At time of procedure
Secondary	Optimal lead placement	based on intraoperative motor response	At time of procedure
Secondary	Voiding log (Bladder Record)	Clinical Outcome	3 months after surgery
Secondary	Clinical Outcome assessed by validated questionnaire		3 months after surgery
Secondary	Inoperative complications	surgery complication	At time of procedure
Secondary	Operative times	minutes	At time of procedure