Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Urge Incontinence; Radiation Exposure; Urgency-frequency Syndrome
• Intervention / Treatment: Procedure: Reduced radiation fluoroscopy; Procedure: Conventional fluoroscopy

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.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Forrest Jellison, MD; Phone Number: 909 558-2830; Email: fjellison@llu.edu

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Recruiting
      • Loma Linda University Health
      • Contact: Forrest Jellison, MD; Phone Number: 909-558-8724; Email: fjellison@llu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Reduced Radiation Fluoroscopy; Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.	Procedure: Reduced radiation fluoroscopy; See previous information about each arm
Active Comparator: Conventional Fluoroscopy; 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.	Procedure: Conventional fluoroscopy; See previous information about each arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Exposure	measure radiation exposure, milligray (mGy)	At time of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal lead placement	based on intraoperative motor response	At time of procedure
Voiding log (Bladder Record)	Clinical Outcome	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

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Forrest Jellison, MD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: August 23, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Fluoroscopy; Sacral Neuromodulation
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Incontinence; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Bladder, Overactive; Urinary Incontinence, Urge
• Other Study ID Numbers: 5200182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No