Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

NCT04527445 | Recruiting

• 1 other identifier: 5200182
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Urgency-frequency Syndrome; Radiation Exposure; Overactive Bladder; Urge Incontinence

Keywords

Sacral Neuromodulation; Fluoroscopy

Outcome Measures

Primary Outcomes (1)

• Radiation Exposure

  measure radiation exposure, milligray (mGy)

  At time of procedure

Secondary Outcomes (5)

• Optimal lead placement

  At time of procedure

• Voiding log (Bladder Record)

  3 months after surgery

• Clinical Outcome assessed by validated questionnaire

  3 months after surgery

• Inoperative complications

  At time of procedure

• Operative times

  At time of procedure

Study Arms (2)

Reduced Radiation Fluoroscopy

EXPERIMENTAL

Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current.

Procedure: Reduced radiation fluoroscopy

Conventional Fluoroscopy

ACTIVE COMPARATOR

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

Interventions

Reduced radiation fluoroscopy PROCEDURE

See previous information about each arm

Reduced Radiation Fluoroscopy

Conventional fluoroscopy PROCEDURE

See previous information about each arm

Conventional Fluoroscopy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.

You may not qualify if:

• neurogenic bladder, BMI \>40, or peripheral neuropathy.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92354, United States

RECRUITING

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Study Officials

• Forrest Jellison, MD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Forrest Jellison, MD

CONTACT

909 558-2830; fjellison@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Subjects notified of the arm after the procedure is performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: August 26, 2020
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)