ClinicalTrials.gg
RecruitingNCT04527445Updated Mar 6, 2026

Fluoroscopy Radiation Reduction During Sacral Neuromodulation Lead Placement

An interventional study of Reduced radiation fluoroscopy and Conventional fluoroscopy in Radiation Exposure, Overactive Bladder and Urge Incontinence, sponsored by Loma Linda University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 333 studies in Urinary Bladder, Overactive with a site in United States — 40 open to participants now, 48 under way, 2 of them phase 3. Urinary Bladder, Overactive · United States.

Planned enrollment
164th of 288
44 · median 66
Started
2026
with 14 others
No phase
113 of 333
20 open now
Primary completion
2027-06
later than 30 of 47 live
Registered
237th of 333
by date

Among the 333 studies in Urinary Bladder, Overactive with a site in United States, this one is the 164th largest by planned enrollment of the 288 interventional ones that give a count, is one of 15 that started in 2026, is one of 113 with no phase, reaches primary completion later than 30 of the 47 other live ones, and was the 237th registered.

Urinary Bladder, Overactive

858 studies on the registry are indexed under Urinary Bladder, Overactive; 126 are open to participants now.

Browse Urinary Bladder, Overactive studies →

Open to participants now

40 of the 333 studies in Urinary Bladder, Overactive with a site in United States are open now. Recruiting first, the newest first:

34 more — sign in →

All 40 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 73 Urinary Bladder, Overactive studies recruiting now, 44 (60%) set no upper age limit and 15 (21%) stop at 75 or younger; 6 take children under 18; 8 take healthy volunteers.

This study: 18 Years to 89 Years · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

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

Keywords

  • Sacral Neuromodulation
  • Fluoroscopy
04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • neurogenic bladder, >40, or peripheral neuropathy.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (estimated)

Study 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.

    Procedure: Reduced radiation fluoroscopy

  • 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

Interventions

  • ProcedureReduced radiation fluoroscopy

    See previous information about each arm

  • ProcedureConventional fluoroscopy

    See previous information about each arm

06

What researchers measure

Primary outcomes

  1. Radiation Exposure

    measure radiation exposure, milligray (mGy)

    Time frame: At time of procedure

Secondary outcomes

  1. Optimal lead placement

    based on intraoperative motor response

    Time frame: At time of procedure

  2. Voiding log (Bladder Record)

    Clinical Outcome

    Time frame: 3 months after surgery

  3. Clinical Outcome assessed by validated questionnaire

    Time frame: 3 months after surgery

  4. Inoperative complications

    surgery complication

    Time frame: At time of procedure

  5. Operative times

    minutes

    Time frame: At time of procedure

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.

Of 133 non-industry interventional studies with no phase under Urinary Bladder, Overactive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's planned 12 months is below that.

Counting every sponsor, half of 174 studies reached it within 19 months; a quarter within 10 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2020
First posted
Aug 26, 2020
StartEst.
Jun 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Mar 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04527445
Responsible party
Sponsor
First posted
Aug 26, 2020
Start date
Jun 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Mar 6, 2026

Study contacts

Forrest Jellison, MD
Contact
fjellison@llu.edu
909 558-2830
Forrest Jellison, MD
principal investigator · Loma Linda University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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