Recruiting

Sacral Neuromodulation

Sponsor:

Loma Linda University

Code:

NCT04527445

Conditions

Radiation Exposure

Overactive Bladder

Urge Incontinence

Urgency-frequency Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Reduced radiation fluoroscopy

Conventional fluoroscopy

Study Details

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

Radiation Exposure

Overactive Bladder

Urge Incontinence

Urgency-frequency Syndrome

Study ID

NCT04527445

Start date

Jun, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reduced Radiation Fluoroscopy

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

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.

Interventions

Reduced radiation fluoroscopy

See previous information about each arm

Conventional fluoroscopy

See previous information about each arm

Primary outcome measure

  • Radiation Exposure [ Time Frame: At time of procedure ]

Central Contacts and Locations

Central contacts

Forrest Jellison, MD

909 558-2830fjellison@llu.edu

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Forrest Jellison, MD

909-558-8724fjellison@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • Sacral Neuromodulation
  • Fluoroscopy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-03-06.