Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Radiation Exposure Overactive Bladder Urge Incontinence Urgency-frequency Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Subjects notified of the arm after the procedure is performed

Study Groups

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Reduced Radiation Fluoroscopy

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

Group Type EXPERIMENTAL

Reduced radiation fluoroscopy

Intervention Type PROCEDURE

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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.

Group Type ACTIVE_COMPARATOR

Conventional fluoroscopy

Intervention Type PROCEDURE

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Interventions

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Reduced radiation fluoroscopy

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Intervention Type PROCEDURE

Conventional fluoroscopy

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Intervention Type PROCEDURE

Eligibility Criteria

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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.