Radiation ExposureNCT04527445
Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement
A study testing Reduced radiation fluoroscopy and Conventional fluoroscopy in people with Radiation Exposure and Overactive Bladder, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Radiation Exposure, Overactive Bladder, Urge Incontinence
- What is being tested?
- Reduced radiation fluoroscopy and Conventional fluoroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
Who cannot join
- neurogenic bladder, BMI >40, or peripheral neuropathy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Health
Loma Linda, California, 92354
Forrest Jellison, MD, 909-558-8724, fjellison@llu.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Reduced radiation fluoroscopy, Conventional fluoroscopy
- Keywords
- Sacral Neuromodulation, Fluoroscopy
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced radiation fluoroscopyProcedure or surgery
See previous information about each arm
Conventional fluoroscopyProcedure or surgery
See previous information about each arm
| Study group | Role | What they receive |
|---|---|---|
| Reduced Radiation Fluoroscopy | Experimental | Reduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current. Receives: 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. Receives: Procedure: Conventional fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Exposure
measure radiation exposure, milligray (mGy)
Measured: At time of procedure
Secondary outcomes (5)
Optimal lead placement
based on intraoperative motor response
Measured: At time of procedure
Voiding log (Bladder Record)
Clinical Outcome
Measured: 3 months after surgery
Clinical Outcome assessed by validated questionnaire
Measured: 3 months after surgery
Inoperative complications
surgery complication
Measured: At time of procedure
Operative times
minutes
Measured: At time of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Forrest Jellison, MD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04527445
- Sponsor's protocol ID
- 5200182
- Status last verified
- Mar 2026
- First submitted
- 23 Aug 2020
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction in Fluoroscopy Radiation Exposure During Lead Implantation for Sacral Neuromodulation: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT04527445
- Acronym / sponsor ID
- 5200182
- Keywords
- Sacral Neuromodulation, Fluoroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Radiation Fluoroscopy | Experimental | Procedure: Reduced radiation fluoroscopyReduced radiation fluoroscopy technique is performed by the C-arm set at 1 pulses-per-second and reduction of current. |
| Conventional Fluoroscopy | Active comparator | Procedure: Conventional fluoroscopyThe standard of care is the conventional fluoroscopy, the C-arm is set at 30 pulses-per-second and the current set as the default. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing lead implantation for sacral neuromodulation that have overactive bladder as defined by urinary urgency, frequency, nocturia with or without urgency incontinence.
Key exclusion criteria (1 listed)
- neurogenic bladder, BMI >40, or peripheral neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced radiation fluoroscopySee previous information about each arm | Procedure or surgery | Reduced Radiation Fluoroscopy |
| Conventional fluoroscopySee previous information about each arm | Procedure or surgery | Conventional Fluoroscopy |
Primary outcome
Radiation Exposure
Time frame: At time of procedure
measure radiation exposure, milligray (mGy)
5 secondary outcomes
Optimal lead placement
Time frame: At time of procedure
Voiding log (Bladder Record)
Time frame: 3 months after surgery
Clinical Outcome assessed by validated questionnaire
Time frame: 3 months after surgery
Inoperative complications
Time frame: At time of procedure
Operative times
Time frame: At time of procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Forrest Jellison, MD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced radiation fluoroscopy and Conventional fluoroscopy in people with Radiation Exposure and Overactive Bladder, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Forrest Jellison, MD (909 558-2830, fjellison@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Exposure (time frame: At time of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026; AzTrials last refreshed its copy on 27 Oct 2026.